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AAP: Food additives inadequately regulated, pose risks to children
The regulation of food additives needs an overhaul in the United States because of the risks these compounds pose to children and infants, according to a new policy statement by the American Academy of Pediatrics.
suggested members of the AAP Council on Environmental Health.
Among the additives of greatest concern, the statement notes, are bisphenols (including bisphenol A), phthalates, certain pesticides, perfluoroalkyl chemicals, perchlorate, artificial food colors, nitrates, and nitrites. A technical report accompanying the policy statement reviewed existing evidence on these compounds.
The statement, authored by the council led by Leonardo Trasande, MD, of New York University, noted that many of the more than 10,000 chemicals added to food and food packaging were grandfathered into use prior to current regulations. Further, approximately 1,000 of these chemicals fall under the Food and Drug Administration’s designation of “generally recognized as safe,” which does not require FDA approval for use.
“Current requirements for a ‘generally recognized as safe’ [GRAS] designation are insufficient to ensure the safety of food additives and do not contain sufficient protections against conflict of interest,” they wrote. “Additionally, the FDA does not have authority to obtain data on or reassess the safety of chemicals already on the market.” The FDA does not regularly consider cumulative effects of food additives or the synergistic effects of chemicals found in foods.
The authors noted that concerns about food additives have increased in the past 20 years as new research has identified adverse health effects, including endocrine disruption, associated with these chemicals.
Dr. Trasande and his associates also acknowledged the limited evidence available on food additives particularly for children and infants, but noted this population’s greater vulnerability to chemical exposures.
Compounds addressed in the statement
- Bisphenols. Health concerns tied to these chemicals are endocrine/neurodevelopmental disruption and obesogenic activity.
- Phthalates. Health concerns linked to these chemicals are endocrine disruption, obesogenic activity, oxidative stress, and cardiotoxicity.
- Perfluoroalkyl chemicals. Health concerns associated with these chemicals are immunosuppression, endocrine disruption, obesogenic activity, and decreased birth weight.
- Perchlorate. The health concern tied to this chemical is thyroid hormone disruption.
- Nitrates and nitrites. Use of these as a preservative and color enhancer has been linked to carcinogenicity and thyroid hormone disruption.
Of these, only nitrates and nitrites are directly added to food while the other chemicals are indirect additives via their use in food packaging that directly touches the food.
How health care providers can help parents and children
“Insofar as these modifications can pose additional costs, barriers may exist for low-income families to reduce their exposure to food additives of concern,” the authors wrote. Health care providers “may wish to tailor guidance in the context of practicality, especially because food insecurity remains a substantial child health concern.”
Their recommendations on guidance for parents include:
- Prioritize fresh or frozen vegetables in meals. “Develop a list of low-cost sources for fresh fruits and vegetables” in the area.
- Avoid processed meats (particularly for mothers during pregnancy).
- Avoid microwaving food in plastic. This includes infant formula and pumped human milk.
- Avoid washing plastics in the dishwasher.
- Use plastic alternatives such as glass or stainless steel.
- Encourage both hand-washing and washing all fruits and vegetables.
- Look at recycling codes on products and avoid plastics with codes 3 (phthalates), 6 (styrene), and 7 (bisphenols) unless labeled as “biobased” or “greenware.”
The statement also encourages health care providers to advocate for updating and strengthening the Toxic Substances Control Act.
The committee also made multiple recommendations for government.
Dr. Trasande and coauthor Rachel M. Shaffer, MPH, received funding from some National Institutes of Health grants. The authors had no relevant financial disclosures.
SOURCES: Trasande L et al. Pediatrics. 2018 Jun 23. doi: 10.1542/peds.2018-1408; doi: 10.1542/ peds. 2018-1410.
The regulation of food additives needs an overhaul in the United States because of the risks these compounds pose to children and infants, according to a new policy statement by the American Academy of Pediatrics.
suggested members of the AAP Council on Environmental Health.
Among the additives of greatest concern, the statement notes, are bisphenols (including bisphenol A), phthalates, certain pesticides, perfluoroalkyl chemicals, perchlorate, artificial food colors, nitrates, and nitrites. A technical report accompanying the policy statement reviewed existing evidence on these compounds.
The statement, authored by the council led by Leonardo Trasande, MD, of New York University, noted that many of the more than 10,000 chemicals added to food and food packaging were grandfathered into use prior to current regulations. Further, approximately 1,000 of these chemicals fall under the Food and Drug Administration’s designation of “generally recognized as safe,” which does not require FDA approval for use.
“Current requirements for a ‘generally recognized as safe’ [GRAS] designation are insufficient to ensure the safety of food additives and do not contain sufficient protections against conflict of interest,” they wrote. “Additionally, the FDA does not have authority to obtain data on or reassess the safety of chemicals already on the market.” The FDA does not regularly consider cumulative effects of food additives or the synergistic effects of chemicals found in foods.
The authors noted that concerns about food additives have increased in the past 20 years as new research has identified adverse health effects, including endocrine disruption, associated with these chemicals.
Dr. Trasande and his associates also acknowledged the limited evidence available on food additives particularly for children and infants, but noted this population’s greater vulnerability to chemical exposures.
Compounds addressed in the statement
- Bisphenols. Health concerns tied to these chemicals are endocrine/neurodevelopmental disruption and obesogenic activity.
- Phthalates. Health concerns linked to these chemicals are endocrine disruption, obesogenic activity, oxidative stress, and cardiotoxicity.
- Perfluoroalkyl chemicals. Health concerns associated with these chemicals are immunosuppression, endocrine disruption, obesogenic activity, and decreased birth weight.
- Perchlorate. The health concern tied to this chemical is thyroid hormone disruption.
- Nitrates and nitrites. Use of these as a preservative and color enhancer has been linked to carcinogenicity and thyroid hormone disruption.
Of these, only nitrates and nitrites are directly added to food while the other chemicals are indirect additives via their use in food packaging that directly touches the food.
How health care providers can help parents and children
“Insofar as these modifications can pose additional costs, barriers may exist for low-income families to reduce their exposure to food additives of concern,” the authors wrote. Health care providers “may wish to tailor guidance in the context of practicality, especially because food insecurity remains a substantial child health concern.”
Their recommendations on guidance for parents include:
- Prioritize fresh or frozen vegetables in meals. “Develop a list of low-cost sources for fresh fruits and vegetables” in the area.
- Avoid processed meats (particularly for mothers during pregnancy).
- Avoid microwaving food in plastic. This includes infant formula and pumped human milk.
- Avoid washing plastics in the dishwasher.
- Use plastic alternatives such as glass or stainless steel.
- Encourage both hand-washing and washing all fruits and vegetables.
- Look at recycling codes on products and avoid plastics with codes 3 (phthalates), 6 (styrene), and 7 (bisphenols) unless labeled as “biobased” or “greenware.”
The statement also encourages health care providers to advocate for updating and strengthening the Toxic Substances Control Act.
The committee also made multiple recommendations for government.
Dr. Trasande and coauthor Rachel M. Shaffer, MPH, received funding from some National Institutes of Health grants. The authors had no relevant financial disclosures.
SOURCES: Trasande L et al. Pediatrics. 2018 Jun 23. doi: 10.1542/peds.2018-1408; doi: 10.1542/ peds. 2018-1410.
The regulation of food additives needs an overhaul in the United States because of the risks these compounds pose to children and infants, according to a new policy statement by the American Academy of Pediatrics.
suggested members of the AAP Council on Environmental Health.
Among the additives of greatest concern, the statement notes, are bisphenols (including bisphenol A), phthalates, certain pesticides, perfluoroalkyl chemicals, perchlorate, artificial food colors, nitrates, and nitrites. A technical report accompanying the policy statement reviewed existing evidence on these compounds.
The statement, authored by the council led by Leonardo Trasande, MD, of New York University, noted that many of the more than 10,000 chemicals added to food and food packaging were grandfathered into use prior to current regulations. Further, approximately 1,000 of these chemicals fall under the Food and Drug Administration’s designation of “generally recognized as safe,” which does not require FDA approval for use.
“Current requirements for a ‘generally recognized as safe’ [GRAS] designation are insufficient to ensure the safety of food additives and do not contain sufficient protections against conflict of interest,” they wrote. “Additionally, the FDA does not have authority to obtain data on or reassess the safety of chemicals already on the market.” The FDA does not regularly consider cumulative effects of food additives or the synergistic effects of chemicals found in foods.
The authors noted that concerns about food additives have increased in the past 20 years as new research has identified adverse health effects, including endocrine disruption, associated with these chemicals.
Dr. Trasande and his associates also acknowledged the limited evidence available on food additives particularly for children and infants, but noted this population’s greater vulnerability to chemical exposures.
Compounds addressed in the statement
- Bisphenols. Health concerns tied to these chemicals are endocrine/neurodevelopmental disruption and obesogenic activity.
- Phthalates. Health concerns linked to these chemicals are endocrine disruption, obesogenic activity, oxidative stress, and cardiotoxicity.
- Perfluoroalkyl chemicals. Health concerns associated with these chemicals are immunosuppression, endocrine disruption, obesogenic activity, and decreased birth weight.
- Perchlorate. The health concern tied to this chemical is thyroid hormone disruption.
- Nitrates and nitrites. Use of these as a preservative and color enhancer has been linked to carcinogenicity and thyroid hormone disruption.
Of these, only nitrates and nitrites are directly added to food while the other chemicals are indirect additives via their use in food packaging that directly touches the food.
How health care providers can help parents and children
“Insofar as these modifications can pose additional costs, barriers may exist for low-income families to reduce their exposure to food additives of concern,” the authors wrote. Health care providers “may wish to tailor guidance in the context of practicality, especially because food insecurity remains a substantial child health concern.”
Their recommendations on guidance for parents include:
- Prioritize fresh or frozen vegetables in meals. “Develop a list of low-cost sources for fresh fruits and vegetables” in the area.
- Avoid processed meats (particularly for mothers during pregnancy).
- Avoid microwaving food in plastic. This includes infant formula and pumped human milk.
- Avoid washing plastics in the dishwasher.
- Use plastic alternatives such as glass or stainless steel.
- Encourage both hand-washing and washing all fruits and vegetables.
- Look at recycling codes on products and avoid plastics with codes 3 (phthalates), 6 (styrene), and 7 (bisphenols) unless labeled as “biobased” or “greenware.”
The statement also encourages health care providers to advocate for updating and strengthening the Toxic Substances Control Act.
The committee also made multiple recommendations for government.
Dr. Trasande and coauthor Rachel M. Shaffer, MPH, received funding from some National Institutes of Health grants. The authors had no relevant financial disclosures.
SOURCES: Trasande L et al. Pediatrics. 2018 Jun 23. doi: 10.1542/peds.2018-1408; doi: 10.1542/ peds. 2018-1410.
FROM PEDIATRICS
Children’s ‘gluten-free’ foods are no healthier than others
Children’s foods labeled as gluten-free (GF) generally had less sodium and fat than other foods marketed for children, but they also had a higher percentage of calories from sugar, a study in Pediatrics found. Further,
Parents and caregivers who are purchasing gluten-free products should carefully assess product labels. Another positive step would be to serve whole, unprocessed food, she wrote in Pediatrics.
Dr. Elliott purchased all child-targeted packaged foods available at two major supermarket chains in Alberta from February 2017 to March 2017, excluding candy, chocolate, potato chips, cheese-flavored snacks, sugary sodas, and similar “junk food” products. Of the 374 foods purchased, 18% had gluten-free claims.
“The intent was to examine the regular foods that have been repackaged to attract children,” she wrote, which she defined as meeting any of the following criteria qualified:
- Contains the word “child” or “kids’” in the product or brand name.
- Has the word “fun” or “play” on the package.
- The foods are linked to children’s TV programs, toys, or movies.
- The foods are promoted for lunch boxes.
- Contains graphics or activities, or promotional offers, intended for children.
- “Presents unusual or child-oriented shapes, unusual colors, or playful product names or tastes.”
Dr. Elliott compared the nutritional content of products labeled as gluten-free with that of products without a gluten-free label based on 100-g servings. She then compared the same GF-labeled products to their equivalent products without a GF label, when possible.
She used the Pan American Health Organization (PAHO) Nutrient Profile Model to evaluate the foods. PAHO criteria for nutritionally poor qualities include the following when applied to “processed” and “ultraprocessed” foods:
- A ratio between sodium and calories greater than or equal to 1.
- Total calories from sugar (glucose, fructose, and disaccharides) at least 10% or more of total calories.
- Contains other nonsugar sweeteners.
- Total calories from fat are at least 30% or more of total calories.
- Total saturated fat is at least at least 10% or more of total calories.
Nearly all the non-gluten free children’s foods (97%) and 88% of the children’s gluten-free foods were considered to have poor nutritional quality (P less than .001). High sugar content was present in 79% of gluten-free products and 81% of their gluten-containing equivalent products (P less than .001).
These foods can be classified as unhealthy because of “their high levels of sugar, sodium, and/or fat, which means that the options for purchasing healthy packaged foods are limited,” Dr. Elliott wrote.
Gluten free–labeled products did have less sodium, total fat, and saturated fat than did those without gluten-free claims, but sugar levels were higher and protein levels lower (nonstatistically significant) in gluten-free products.
“Such findings echo those in other studies of child-targeted supermarket foods and reveal that products marketed as ‘better for you’ for children are as much about marketing as they are about nutrition,” Dr. Elliott wrote. “Given children’s lower daily caloric intake and the challenges associated with consuming a nutrient-rich, gluten-free diet for children with celiac disease in particular, it is important that the products designed for children are held to a higher nutritional standard.”
The study’s biggest limitations are its inability to represent all child-marketed packaged foods available in stores and the fact that many foods labeled as “gluten-free” would not have gluten in them anyway, such as apple sauce and fruit snacks.
“In this case, the use of a gluten-free claim on products that are inherently free of gluten might be understood as a marketing tool directed at consumers who view gluten-free products as healthier than their regular counterparts,” Dr. Elliott noted
The research was funded by the Canadian Institutes of Health Research’s Canada Research Chairs Program. Dr. Elliott had no relevant financial disclosures.
SOURCE: Elliott C. Pediatrics. 2018 Jul 20. doi: 10.1542/peds.2018-0525.
Children’s foods labeled as gluten-free (GF) generally had less sodium and fat than other foods marketed for children, but they also had a higher percentage of calories from sugar, a study in Pediatrics found. Further,
Parents and caregivers who are purchasing gluten-free products should carefully assess product labels. Another positive step would be to serve whole, unprocessed food, she wrote in Pediatrics.
Dr. Elliott purchased all child-targeted packaged foods available at two major supermarket chains in Alberta from February 2017 to March 2017, excluding candy, chocolate, potato chips, cheese-flavored snacks, sugary sodas, and similar “junk food” products. Of the 374 foods purchased, 18% had gluten-free claims.
“The intent was to examine the regular foods that have been repackaged to attract children,” she wrote, which she defined as meeting any of the following criteria qualified:
- Contains the word “child” or “kids’” in the product or brand name.
- Has the word “fun” or “play” on the package.
- The foods are linked to children’s TV programs, toys, or movies.
- The foods are promoted for lunch boxes.
- Contains graphics or activities, or promotional offers, intended for children.
- “Presents unusual or child-oriented shapes, unusual colors, or playful product names or tastes.”
Dr. Elliott compared the nutritional content of products labeled as gluten-free with that of products without a gluten-free label based on 100-g servings. She then compared the same GF-labeled products to their equivalent products without a GF label, when possible.
She used the Pan American Health Organization (PAHO) Nutrient Profile Model to evaluate the foods. PAHO criteria for nutritionally poor qualities include the following when applied to “processed” and “ultraprocessed” foods:
- A ratio between sodium and calories greater than or equal to 1.
- Total calories from sugar (glucose, fructose, and disaccharides) at least 10% or more of total calories.
- Contains other nonsugar sweeteners.
- Total calories from fat are at least 30% or more of total calories.
- Total saturated fat is at least at least 10% or more of total calories.
Nearly all the non-gluten free children’s foods (97%) and 88% of the children’s gluten-free foods were considered to have poor nutritional quality (P less than .001). High sugar content was present in 79% of gluten-free products and 81% of their gluten-containing equivalent products (P less than .001).
These foods can be classified as unhealthy because of “their high levels of sugar, sodium, and/or fat, which means that the options for purchasing healthy packaged foods are limited,” Dr. Elliott wrote.
Gluten free–labeled products did have less sodium, total fat, and saturated fat than did those without gluten-free claims, but sugar levels were higher and protein levels lower (nonstatistically significant) in gluten-free products.
“Such findings echo those in other studies of child-targeted supermarket foods and reveal that products marketed as ‘better for you’ for children are as much about marketing as they are about nutrition,” Dr. Elliott wrote. “Given children’s lower daily caloric intake and the challenges associated with consuming a nutrient-rich, gluten-free diet for children with celiac disease in particular, it is important that the products designed for children are held to a higher nutritional standard.”
The study’s biggest limitations are its inability to represent all child-marketed packaged foods available in stores and the fact that many foods labeled as “gluten-free” would not have gluten in them anyway, such as apple sauce and fruit snacks.
“In this case, the use of a gluten-free claim on products that are inherently free of gluten might be understood as a marketing tool directed at consumers who view gluten-free products as healthier than their regular counterparts,” Dr. Elliott noted
The research was funded by the Canadian Institutes of Health Research’s Canada Research Chairs Program. Dr. Elliott had no relevant financial disclosures.
SOURCE: Elliott C. Pediatrics. 2018 Jul 20. doi: 10.1542/peds.2018-0525.
Children’s foods labeled as gluten-free (GF) generally had less sodium and fat than other foods marketed for children, but they also had a higher percentage of calories from sugar, a study in Pediatrics found. Further,
Parents and caregivers who are purchasing gluten-free products should carefully assess product labels. Another positive step would be to serve whole, unprocessed food, she wrote in Pediatrics.
Dr. Elliott purchased all child-targeted packaged foods available at two major supermarket chains in Alberta from February 2017 to March 2017, excluding candy, chocolate, potato chips, cheese-flavored snacks, sugary sodas, and similar “junk food” products. Of the 374 foods purchased, 18% had gluten-free claims.
“The intent was to examine the regular foods that have been repackaged to attract children,” she wrote, which she defined as meeting any of the following criteria qualified:
- Contains the word “child” or “kids’” in the product or brand name.
- Has the word “fun” or “play” on the package.
- The foods are linked to children’s TV programs, toys, or movies.
- The foods are promoted for lunch boxes.
- Contains graphics or activities, or promotional offers, intended for children.
- “Presents unusual or child-oriented shapes, unusual colors, or playful product names or tastes.”
Dr. Elliott compared the nutritional content of products labeled as gluten-free with that of products without a gluten-free label based on 100-g servings. She then compared the same GF-labeled products to their equivalent products without a GF label, when possible.
She used the Pan American Health Organization (PAHO) Nutrient Profile Model to evaluate the foods. PAHO criteria for nutritionally poor qualities include the following when applied to “processed” and “ultraprocessed” foods:
- A ratio between sodium and calories greater than or equal to 1.
- Total calories from sugar (glucose, fructose, and disaccharides) at least 10% or more of total calories.
- Contains other nonsugar sweeteners.
- Total calories from fat are at least 30% or more of total calories.
- Total saturated fat is at least at least 10% or more of total calories.
Nearly all the non-gluten free children’s foods (97%) and 88% of the children’s gluten-free foods were considered to have poor nutritional quality (P less than .001). High sugar content was present in 79% of gluten-free products and 81% of their gluten-containing equivalent products (P less than .001).
These foods can be classified as unhealthy because of “their high levels of sugar, sodium, and/or fat, which means that the options for purchasing healthy packaged foods are limited,” Dr. Elliott wrote.
Gluten free–labeled products did have less sodium, total fat, and saturated fat than did those without gluten-free claims, but sugar levels were higher and protein levels lower (nonstatistically significant) in gluten-free products.
“Such findings echo those in other studies of child-targeted supermarket foods and reveal that products marketed as ‘better for you’ for children are as much about marketing as they are about nutrition,” Dr. Elliott wrote. “Given children’s lower daily caloric intake and the challenges associated with consuming a nutrient-rich, gluten-free diet for children with celiac disease in particular, it is important that the products designed for children are held to a higher nutritional standard.”
The study’s biggest limitations are its inability to represent all child-marketed packaged foods available in stores and the fact that many foods labeled as “gluten-free” would not have gluten in them anyway, such as apple sauce and fruit snacks.
“In this case, the use of a gluten-free claim on products that are inherently free of gluten might be understood as a marketing tool directed at consumers who view gluten-free products as healthier than their regular counterparts,” Dr. Elliott noted
The research was funded by the Canadian Institutes of Health Research’s Canada Research Chairs Program. Dr. Elliott had no relevant financial disclosures.
SOURCE: Elliott C. Pediatrics. 2018 Jul 20. doi: 10.1542/peds.2018-0525.
FROM PEDIATRICS
Key clinical point: Most prepackaged gluten-free foods marketed for children are unhealthy.
Major finding: Of gluten-free packaged children’s foods, 88% had poor nutritional quality, as did 97% of children’s food not labeled as gluten-free.
Study details: The findings are based on a comparison of 374 child-marketed packaged foods, including 66 gluten free–labeled foods and their non-gluten free equivalents and other non-gluten free foods.
Disclosures: The research was funded by the Canadian Institutes of Health Research’s Canada Research Chairs Program. Dr. Elliott had no relevant financial disclosures.
Source: Elliott C. Pediatrics. 2018 Jul 20. doi: 10.1542/peds.2018-0525.
Spinal muscular atrophy added to newborn screening panel recommendations
Spinal muscular atrophy (SMA) is now among the disorders officially included in the Recommended Uniform Screening Panel (RUSP), which is used by state public health departments to screen newborns for genetic disorders.
Secretary of the Department of Health and Human Services Alex M. Azar II formally added SMA to the panel July 2 on the recommendation of the Advisory Committee on Heritable Disorders in Newborns and Children.
“Adding SMA to the list will help ensure that babies born with SMA are identified, so that they have the opportunity to benefit from early treatment and intervention,” according to a statement from the Muscular Dystrophy Association about the decision. “This testing can also provide families with a genetic diagnosis – information that often is required to determine whether their child is eligible to participate in clinical trials.”
Adding SMA to the RUSP does not mean states must screen newborns for the disorder. Each state’s public health apparatus decides independently whether to accept the recommendation and which disorders on the RUSP to screen for. Most states screen for most disorders on the RUSP. Evidence compiled by the advisory committee suggested wide variation in resources, infrastructure, funding, and time to implementation among states.
An estimated 1 in 11,000 newborns have SMA, a disorder caused by mutations in the survival motor neuron 1 (SMN1) gene. SMA affects motor neurons in the brain stem and spinal cord leading to motor weakness and atrophy. The only treatment for SMA had been palliative care until the Food and Drug Administration approved nusinersen (Spinraza) for the disorder in December 2016, although the drug’s approval has raised some ethical questions.1-3
After reviewing the evidence at their February 8, 2018 meeting, the advisory committee recommended the addition of spinal muscular atrophy screening to the RUSP in a March 8, 2018, letter from committee chair Joseph A. Bocchini Jr., MD, who is a professor and the chairman of the department of pediatrics at Louisiana State University Health in Shreveport.
Secretary Azar accepted the recommendation based on the evidence the committee provided; he also requested a follow-up report within 2 years “describing the status of implementing newborn screening for SMA and clinical outcomes of early treatment, including any potential harms, for infants diagnosed with SMA.”
The advisory committee makes its recommendations to the HHS on which heritable disorders to include in the RUSP after they have assessed a systematic, evidence-based review assigned by the committee to an external independent group. Alex R. Kemper, MD, MPH, a professor of pediatrics at the Ohio State University and division chief of ambulatory pediatrics at Nationwide Children’s Hospital, both in Columbus, led the review group for SMA. Dr. Kemper is also deputy editor of the journal Pediatrics and a member of the U.S. Preventive Services Task Force.
According to Secretary Azar’s summary in his July 2, 2018, letter of acceptance, the evidence review suggested that “early screening and treatment can lead to decreased mortality for individuals with SMA and improved motor milestones.”
Dr. Kemper elaborated in an interview that, “SMA can be detected through newborn screening, and treatment is now available that can not only reduce the risk of death but decrease the development of neurologic impairment. As with adding any condition to newborn screening, public health laboratories will need to develop strategies to incorporate the screening test. The current FDA-approved treatment, nusinersen, is delivered by lumbar puncture into the spinal fluid. In addition, there are exciting advances in gene therapy leading to new treatment approaches.”
Approximately 95% of SMA cases result from the deletion of exon 7 from both alleles of SMN1. (Other rarer cases are caused by mutations in different genes.) Without the SMN protein produced by SMN1, a person gradually loses muscle function.
A similar gene, SMN2, also can produce the SMN protein but in much lower amounts, typically less than 10% of what a person needs. People can, however, have multiple copies of SMN2, which can produce slightly more SMN protein for a slower disease process.
The five types of spinal muscular atrophy are determined according to symptom onset, which directly correlates with disorder severity and prognosis. Just over half (54%) of SMA cases are Type I, in which progressive weakness occurs over the first 6 months of life and results in early death. Only 18% of children with Type I live past age 4 years, and 68% die by age 2 years. Type 0 is rarer but more severe, usually causing fetal loss or early infant death.
Type II represents 18% of SMA cases and causes progressive weakness by age 15 months. Most people with Type II survive to their 30s but then experience respiratory failure and rarely reach their fourth decade. Individuals with Types III and IV typically have a normal lifespan and only begin to see progressive muscle weakness after 1 year old or in adulthood.
Dr. Kemper’s group focused on the three types diagnosed in infancy: types I, II, and III.
Dr. Kemper emphasized in an interview that “it will be critical to make sure that infants diagnosed with SMA through newborn screening receive follow-up shortly afterward to determine whether they would benefit from nusinersen. More information is needed about the long-term outcomes of those infants who begin treatment following newborn screening so we not only know about outcomes in later childhood and adolescence but treatment approaches can be further refined and personalized.”
Nusinersen works by altering the splicing of precursor messenger RNA in SMN2 so that the mRNA strands are longer, which thereby increases how much SMN protein is produced. Concerns about the medication, however, have included its cost – $750,000 in the first year and $375,000 every following year for life – and potential adverse events from repeated administration. Nusinersen is injected into the spinal canal four times in the first year and then once annually, and the painful injections require patient immobilization. Potential adverse events include thrombocytopenia and nephrotoxicity, along with potential complications from repeated lumbar punctures over time.2
Other concerns about the drug include its limited evidence base, lack of long-term data, associated costs with administration (for example, travel costs), the potential for patients taking nusinersen to be excluded from future clinical trials on other treatments, and ensuring parents have enough information on the drug’s limitations and potential risks to provide adequate informed consent.2
Yet evidence to date is favorable in children with early onset. Dr. Bocchini wrote in the letter to Secretary Azar that “limited data suggest that treatment effect is greater when the treatment is initiated before symptoms develop and when the individual has more copies of SMN2.”
Dr. Kemper’s group concluded that screening can detect SMA in newborns and that treatment can modify disease course. “Grey literature suggests those with total disease duration less than or equal to 12 weeks before nusinersen treatment were more likely to have better outcomes than those with longer periods of disease duration.”
“Presymptomatic treatment alters the natural history” of the disorder, the group found, although outcome data past 1 year of age are not yet available. Based on findings from a New York pilot program, they predicted that nationwide newborn screening would avert 33 deaths and 48 cases of children who were dependent on a ventilator among an annual cohort of 4 million births.
At the time of the evidence review, Massachusetts, Minnesota, Missouri, North Carolina, New York, Utah, and Wisconsin initiated pilot programs or whole-population mandated screening for SMA. Of the three states that reported costs, all reported costs at $1 or less per screen.
The research for the evidence review was funded by a Health Resources and Services Administration grant to Duke University, Durham, N.C. No disclosures were provided for evidence review group members.
References
1. Gene Ther. 2017 Sep;24(9):534-8.
2. JAMA Intern Med. 2018 Jun 1;178(6):743-44.
3. JAMA Pediatr. 2018 Feb 1;172(2):188-92.
Spinal muscular atrophy (SMA) is now among the disorders officially included in the Recommended Uniform Screening Panel (RUSP), which is used by state public health departments to screen newborns for genetic disorders.
Secretary of the Department of Health and Human Services Alex M. Azar II formally added SMA to the panel July 2 on the recommendation of the Advisory Committee on Heritable Disorders in Newborns and Children.
“Adding SMA to the list will help ensure that babies born with SMA are identified, so that they have the opportunity to benefit from early treatment and intervention,” according to a statement from the Muscular Dystrophy Association about the decision. “This testing can also provide families with a genetic diagnosis – information that often is required to determine whether their child is eligible to participate in clinical trials.”
Adding SMA to the RUSP does not mean states must screen newborns for the disorder. Each state’s public health apparatus decides independently whether to accept the recommendation and which disorders on the RUSP to screen for. Most states screen for most disorders on the RUSP. Evidence compiled by the advisory committee suggested wide variation in resources, infrastructure, funding, and time to implementation among states.
An estimated 1 in 11,000 newborns have SMA, a disorder caused by mutations in the survival motor neuron 1 (SMN1) gene. SMA affects motor neurons in the brain stem and spinal cord leading to motor weakness and atrophy. The only treatment for SMA had been palliative care until the Food and Drug Administration approved nusinersen (Spinraza) for the disorder in December 2016, although the drug’s approval has raised some ethical questions.1-3
After reviewing the evidence at their February 8, 2018 meeting, the advisory committee recommended the addition of spinal muscular atrophy screening to the RUSP in a March 8, 2018, letter from committee chair Joseph A. Bocchini Jr., MD, who is a professor and the chairman of the department of pediatrics at Louisiana State University Health in Shreveport.
Secretary Azar accepted the recommendation based on the evidence the committee provided; he also requested a follow-up report within 2 years “describing the status of implementing newborn screening for SMA and clinical outcomes of early treatment, including any potential harms, for infants diagnosed with SMA.”
The advisory committee makes its recommendations to the HHS on which heritable disorders to include in the RUSP after they have assessed a systematic, evidence-based review assigned by the committee to an external independent group. Alex R. Kemper, MD, MPH, a professor of pediatrics at the Ohio State University and division chief of ambulatory pediatrics at Nationwide Children’s Hospital, both in Columbus, led the review group for SMA. Dr. Kemper is also deputy editor of the journal Pediatrics and a member of the U.S. Preventive Services Task Force.
According to Secretary Azar’s summary in his July 2, 2018, letter of acceptance, the evidence review suggested that “early screening and treatment can lead to decreased mortality for individuals with SMA and improved motor milestones.”
Dr. Kemper elaborated in an interview that, “SMA can be detected through newborn screening, and treatment is now available that can not only reduce the risk of death but decrease the development of neurologic impairment. As with adding any condition to newborn screening, public health laboratories will need to develop strategies to incorporate the screening test. The current FDA-approved treatment, nusinersen, is delivered by lumbar puncture into the spinal fluid. In addition, there are exciting advances in gene therapy leading to new treatment approaches.”
Approximately 95% of SMA cases result from the deletion of exon 7 from both alleles of SMN1. (Other rarer cases are caused by mutations in different genes.) Without the SMN protein produced by SMN1, a person gradually loses muscle function.
A similar gene, SMN2, also can produce the SMN protein but in much lower amounts, typically less than 10% of what a person needs. People can, however, have multiple copies of SMN2, which can produce slightly more SMN protein for a slower disease process.
The five types of spinal muscular atrophy are determined according to symptom onset, which directly correlates with disorder severity and prognosis. Just over half (54%) of SMA cases are Type I, in which progressive weakness occurs over the first 6 months of life and results in early death. Only 18% of children with Type I live past age 4 years, and 68% die by age 2 years. Type 0 is rarer but more severe, usually causing fetal loss or early infant death.
Type II represents 18% of SMA cases and causes progressive weakness by age 15 months. Most people with Type II survive to their 30s but then experience respiratory failure and rarely reach their fourth decade. Individuals with Types III and IV typically have a normal lifespan and only begin to see progressive muscle weakness after 1 year old or in adulthood.
Dr. Kemper’s group focused on the three types diagnosed in infancy: types I, II, and III.
Dr. Kemper emphasized in an interview that “it will be critical to make sure that infants diagnosed with SMA through newborn screening receive follow-up shortly afterward to determine whether they would benefit from nusinersen. More information is needed about the long-term outcomes of those infants who begin treatment following newborn screening so we not only know about outcomes in later childhood and adolescence but treatment approaches can be further refined and personalized.”
Nusinersen works by altering the splicing of precursor messenger RNA in SMN2 so that the mRNA strands are longer, which thereby increases how much SMN protein is produced. Concerns about the medication, however, have included its cost – $750,000 in the first year and $375,000 every following year for life – and potential adverse events from repeated administration. Nusinersen is injected into the spinal canal four times in the first year and then once annually, and the painful injections require patient immobilization. Potential adverse events include thrombocytopenia and nephrotoxicity, along with potential complications from repeated lumbar punctures over time.2
Other concerns about the drug include its limited evidence base, lack of long-term data, associated costs with administration (for example, travel costs), the potential for patients taking nusinersen to be excluded from future clinical trials on other treatments, and ensuring parents have enough information on the drug’s limitations and potential risks to provide adequate informed consent.2
Yet evidence to date is favorable in children with early onset. Dr. Bocchini wrote in the letter to Secretary Azar that “limited data suggest that treatment effect is greater when the treatment is initiated before symptoms develop and when the individual has more copies of SMN2.”
Dr. Kemper’s group concluded that screening can detect SMA in newborns and that treatment can modify disease course. “Grey literature suggests those with total disease duration less than or equal to 12 weeks before nusinersen treatment were more likely to have better outcomes than those with longer periods of disease duration.”
“Presymptomatic treatment alters the natural history” of the disorder, the group found, although outcome data past 1 year of age are not yet available. Based on findings from a New York pilot program, they predicted that nationwide newborn screening would avert 33 deaths and 48 cases of children who were dependent on a ventilator among an annual cohort of 4 million births.
At the time of the evidence review, Massachusetts, Minnesota, Missouri, North Carolina, New York, Utah, and Wisconsin initiated pilot programs or whole-population mandated screening for SMA. Of the three states that reported costs, all reported costs at $1 or less per screen.
The research for the evidence review was funded by a Health Resources and Services Administration grant to Duke University, Durham, N.C. No disclosures were provided for evidence review group members.
References
1. Gene Ther. 2017 Sep;24(9):534-8.
2. JAMA Intern Med. 2018 Jun 1;178(6):743-44.
3. JAMA Pediatr. 2018 Feb 1;172(2):188-92.
Spinal muscular atrophy (SMA) is now among the disorders officially included in the Recommended Uniform Screening Panel (RUSP), which is used by state public health departments to screen newborns for genetic disorders.
Secretary of the Department of Health and Human Services Alex M. Azar II formally added SMA to the panel July 2 on the recommendation of the Advisory Committee on Heritable Disorders in Newborns and Children.
“Adding SMA to the list will help ensure that babies born with SMA are identified, so that they have the opportunity to benefit from early treatment and intervention,” according to a statement from the Muscular Dystrophy Association about the decision. “This testing can also provide families with a genetic diagnosis – information that often is required to determine whether their child is eligible to participate in clinical trials.”
Adding SMA to the RUSP does not mean states must screen newborns for the disorder. Each state’s public health apparatus decides independently whether to accept the recommendation and which disorders on the RUSP to screen for. Most states screen for most disorders on the RUSP. Evidence compiled by the advisory committee suggested wide variation in resources, infrastructure, funding, and time to implementation among states.
An estimated 1 in 11,000 newborns have SMA, a disorder caused by mutations in the survival motor neuron 1 (SMN1) gene. SMA affects motor neurons in the brain stem and spinal cord leading to motor weakness and atrophy. The only treatment for SMA had been palliative care until the Food and Drug Administration approved nusinersen (Spinraza) for the disorder in December 2016, although the drug’s approval has raised some ethical questions.1-3
After reviewing the evidence at their February 8, 2018 meeting, the advisory committee recommended the addition of spinal muscular atrophy screening to the RUSP in a March 8, 2018, letter from committee chair Joseph A. Bocchini Jr., MD, who is a professor and the chairman of the department of pediatrics at Louisiana State University Health in Shreveport.
Secretary Azar accepted the recommendation based on the evidence the committee provided; he also requested a follow-up report within 2 years “describing the status of implementing newborn screening for SMA and clinical outcomes of early treatment, including any potential harms, for infants diagnosed with SMA.”
The advisory committee makes its recommendations to the HHS on which heritable disorders to include in the RUSP after they have assessed a systematic, evidence-based review assigned by the committee to an external independent group. Alex R. Kemper, MD, MPH, a professor of pediatrics at the Ohio State University and division chief of ambulatory pediatrics at Nationwide Children’s Hospital, both in Columbus, led the review group for SMA. Dr. Kemper is also deputy editor of the journal Pediatrics and a member of the U.S. Preventive Services Task Force.
According to Secretary Azar’s summary in his July 2, 2018, letter of acceptance, the evidence review suggested that “early screening and treatment can lead to decreased mortality for individuals with SMA and improved motor milestones.”
Dr. Kemper elaborated in an interview that, “SMA can be detected through newborn screening, and treatment is now available that can not only reduce the risk of death but decrease the development of neurologic impairment. As with adding any condition to newborn screening, public health laboratories will need to develop strategies to incorporate the screening test. The current FDA-approved treatment, nusinersen, is delivered by lumbar puncture into the spinal fluid. In addition, there are exciting advances in gene therapy leading to new treatment approaches.”
Approximately 95% of SMA cases result from the deletion of exon 7 from both alleles of SMN1. (Other rarer cases are caused by mutations in different genes.) Without the SMN protein produced by SMN1, a person gradually loses muscle function.
A similar gene, SMN2, also can produce the SMN protein but in much lower amounts, typically less than 10% of what a person needs. People can, however, have multiple copies of SMN2, which can produce slightly more SMN protein for a slower disease process.
The five types of spinal muscular atrophy are determined according to symptom onset, which directly correlates with disorder severity and prognosis. Just over half (54%) of SMA cases are Type I, in which progressive weakness occurs over the first 6 months of life and results in early death. Only 18% of children with Type I live past age 4 years, and 68% die by age 2 years. Type 0 is rarer but more severe, usually causing fetal loss or early infant death.
Type II represents 18% of SMA cases and causes progressive weakness by age 15 months. Most people with Type II survive to their 30s but then experience respiratory failure and rarely reach their fourth decade. Individuals with Types III and IV typically have a normal lifespan and only begin to see progressive muscle weakness after 1 year old or in adulthood.
Dr. Kemper’s group focused on the three types diagnosed in infancy: types I, II, and III.
Dr. Kemper emphasized in an interview that “it will be critical to make sure that infants diagnosed with SMA through newborn screening receive follow-up shortly afterward to determine whether they would benefit from nusinersen. More information is needed about the long-term outcomes of those infants who begin treatment following newborn screening so we not only know about outcomes in later childhood and adolescence but treatment approaches can be further refined and personalized.”
Nusinersen works by altering the splicing of precursor messenger RNA in SMN2 so that the mRNA strands are longer, which thereby increases how much SMN protein is produced. Concerns about the medication, however, have included its cost – $750,000 in the first year and $375,000 every following year for life – and potential adverse events from repeated administration. Nusinersen is injected into the spinal canal four times in the first year and then once annually, and the painful injections require patient immobilization. Potential adverse events include thrombocytopenia and nephrotoxicity, along with potential complications from repeated lumbar punctures over time.2
Other concerns about the drug include its limited evidence base, lack of long-term data, associated costs with administration (for example, travel costs), the potential for patients taking nusinersen to be excluded from future clinical trials on other treatments, and ensuring parents have enough information on the drug’s limitations and potential risks to provide adequate informed consent.2
Yet evidence to date is favorable in children with early onset. Dr. Bocchini wrote in the letter to Secretary Azar that “limited data suggest that treatment effect is greater when the treatment is initiated before symptoms develop and when the individual has more copies of SMN2.”
Dr. Kemper’s group concluded that screening can detect SMA in newborns and that treatment can modify disease course. “Grey literature suggests those with total disease duration less than or equal to 12 weeks before nusinersen treatment were more likely to have better outcomes than those with longer periods of disease duration.”
“Presymptomatic treatment alters the natural history” of the disorder, the group found, although outcome data past 1 year of age are not yet available. Based on findings from a New York pilot program, they predicted that nationwide newborn screening would avert 33 deaths and 48 cases of children who were dependent on a ventilator among an annual cohort of 4 million births.
At the time of the evidence review, Massachusetts, Minnesota, Missouri, North Carolina, New York, Utah, and Wisconsin initiated pilot programs or whole-population mandated screening for SMA. Of the three states that reported costs, all reported costs at $1 or less per screen.
The research for the evidence review was funded by a Health Resources and Services Administration grant to Duke University, Durham, N.C. No disclosures were provided for evidence review group members.
References
1. Gene Ther. 2017 Sep;24(9):534-8.
2. JAMA Intern Med. 2018 Jun 1;178(6):743-44.
3. JAMA Pediatr. 2018 Feb 1;172(2):188-92.
Antidepressant use linked to increased weight gain
Taking antidepressants appears associated with weight gain in a recent study, though the researchers caution that the link might not be causal. Antidepressant use already was lowest in those with an initially normal BMI, and it increased with each category of greater BMI.
“Participants of normal weight showed an increased risk of transitioning to overweight or obesity, and overweight participants were more likely to become obese if they were treated with an antidepressant,” Rafael Gafoor, PhD, of King’s College London, and his associates wrote in BMJ.
“The risk of weight gain was substantially increased during the second and third years of treatment,” they reported. “The risk of weight gain remained increased during at least 6 years of follow-up.”
The researchers retrospectively analyzed EHRs from the U.K. Clinical Practice Research Datalink, representing about 7% of general practices in the United Kingdom, to compare the risk of weight gain among those who were and were not prescribed antidepressants. Of more than 2 million registered participants, a random sample of those with at least three measurements for body mass index (BMI), representing different weight classes, were included.
Out of 136,762 men and 157,957 women, 13% of the men and 22.4% of the women received prescriptions for antidepressants. The 10-year follow-up period included more than 1.8 million person-years. The proportion of people gaining at least 5% in BMI was 11.1% in those with antidepressants prescriptions, compared with 8.1% in those not prescribed antidepressants.
“Antidepressant use was greater in patients with comorbidity and coprescriptions, particularly with diagnoses of stroke and diabetes or coprescribing of antiepileptics or antipsychotics, than in those without,” the researchers wrote. “Antidepressant use was also associated with current smoking and higher deprivation category.”
The researchers adjusted the analysis to account for age, sex, initial BMI classification, smoking, prescriptions for antiepileptics or antipsychotics, year, region of residence, socioeconomic status, or having received advice on weight management or diet. They also accounted for diabetes, coronary heart disease, stroke, cancer, and depression diagnoses, and they eliminated the 280 days before a newborn delivery to account for pregnancy-related weight increases.
After adjustment for those potential confounders, people prescribed antidepressants were 21% more likely to experience substantial weight gain than those not prescribed them (adjusted rate ratio = 1.21; P less than .001). The researchers, cautioned, however, that residual confounding might have inflated the risk.
Those who had a normal weight when they began taking antidepressants had 29% greater risk of gaining enough weight to meet the criteria for overweight or obesity. Likewise, those already overweight when first prescribed antidepressants were 29% more likely to develop obesity.
For every 27 patients who took antidepressants for at least 1 year, 1 of them gained at least 5% in BMI during the subsequent year. Again, however, the researchers emphasized the absence of evidence for causality and the risk of bias from confounding.
Mirtazapine was the antidepressant associated with the highest incidence ratio of weight gain, but that drug was prescribed infrequently.
“From a clinical perspective, these observations reinforce the need for active body weight management to accompany widespread antidepressant treatment, although this might often be met with limited success,” the authors wrote.
The research was funded by the National Health Service Foundation Trust and by King’s College London. Aside from one author’s employment with the U.K. Clinical Practice Research Datalink data source, the authors had no disclosures.
SOURCE: Gafoor R et al. BMJ. 2018;361:k1951. doi: 10.1136/bmj.k1951.
Taking antidepressants appears associated with weight gain in a recent study, though the researchers caution that the link might not be causal. Antidepressant use already was lowest in those with an initially normal BMI, and it increased with each category of greater BMI.
“Participants of normal weight showed an increased risk of transitioning to overweight or obesity, and overweight participants were more likely to become obese if they were treated with an antidepressant,” Rafael Gafoor, PhD, of King’s College London, and his associates wrote in BMJ.
“The risk of weight gain was substantially increased during the second and third years of treatment,” they reported. “The risk of weight gain remained increased during at least 6 years of follow-up.”
The researchers retrospectively analyzed EHRs from the U.K. Clinical Practice Research Datalink, representing about 7% of general practices in the United Kingdom, to compare the risk of weight gain among those who were and were not prescribed antidepressants. Of more than 2 million registered participants, a random sample of those with at least three measurements for body mass index (BMI), representing different weight classes, were included.
Out of 136,762 men and 157,957 women, 13% of the men and 22.4% of the women received prescriptions for antidepressants. The 10-year follow-up period included more than 1.8 million person-years. The proportion of people gaining at least 5% in BMI was 11.1% in those with antidepressants prescriptions, compared with 8.1% in those not prescribed antidepressants.
“Antidepressant use was greater in patients with comorbidity and coprescriptions, particularly with diagnoses of stroke and diabetes or coprescribing of antiepileptics or antipsychotics, than in those without,” the researchers wrote. “Antidepressant use was also associated with current smoking and higher deprivation category.”
The researchers adjusted the analysis to account for age, sex, initial BMI classification, smoking, prescriptions for antiepileptics or antipsychotics, year, region of residence, socioeconomic status, or having received advice on weight management or diet. They also accounted for diabetes, coronary heart disease, stroke, cancer, and depression diagnoses, and they eliminated the 280 days before a newborn delivery to account for pregnancy-related weight increases.
After adjustment for those potential confounders, people prescribed antidepressants were 21% more likely to experience substantial weight gain than those not prescribed them (adjusted rate ratio = 1.21; P less than .001). The researchers, cautioned, however, that residual confounding might have inflated the risk.
Those who had a normal weight when they began taking antidepressants had 29% greater risk of gaining enough weight to meet the criteria for overweight or obesity. Likewise, those already overweight when first prescribed antidepressants were 29% more likely to develop obesity.
For every 27 patients who took antidepressants for at least 1 year, 1 of them gained at least 5% in BMI during the subsequent year. Again, however, the researchers emphasized the absence of evidence for causality and the risk of bias from confounding.
Mirtazapine was the antidepressant associated with the highest incidence ratio of weight gain, but that drug was prescribed infrequently.
“From a clinical perspective, these observations reinforce the need for active body weight management to accompany widespread antidepressant treatment, although this might often be met with limited success,” the authors wrote.
The research was funded by the National Health Service Foundation Trust and by King’s College London. Aside from one author’s employment with the U.K. Clinical Practice Research Datalink data source, the authors had no disclosures.
SOURCE: Gafoor R et al. BMJ. 2018;361:k1951. doi: 10.1136/bmj.k1951.
Taking antidepressants appears associated with weight gain in a recent study, though the researchers caution that the link might not be causal. Antidepressant use already was lowest in those with an initially normal BMI, and it increased with each category of greater BMI.
“Participants of normal weight showed an increased risk of transitioning to overweight or obesity, and overweight participants were more likely to become obese if they were treated with an antidepressant,” Rafael Gafoor, PhD, of King’s College London, and his associates wrote in BMJ.
“The risk of weight gain was substantially increased during the second and third years of treatment,” they reported. “The risk of weight gain remained increased during at least 6 years of follow-up.”
The researchers retrospectively analyzed EHRs from the U.K. Clinical Practice Research Datalink, representing about 7% of general practices in the United Kingdom, to compare the risk of weight gain among those who were and were not prescribed antidepressants. Of more than 2 million registered participants, a random sample of those with at least three measurements for body mass index (BMI), representing different weight classes, were included.
Out of 136,762 men and 157,957 women, 13% of the men and 22.4% of the women received prescriptions for antidepressants. The 10-year follow-up period included more than 1.8 million person-years. The proportion of people gaining at least 5% in BMI was 11.1% in those with antidepressants prescriptions, compared with 8.1% in those not prescribed antidepressants.
“Antidepressant use was greater in patients with comorbidity and coprescriptions, particularly with diagnoses of stroke and diabetes or coprescribing of antiepileptics or antipsychotics, than in those without,” the researchers wrote. “Antidepressant use was also associated with current smoking and higher deprivation category.”
The researchers adjusted the analysis to account for age, sex, initial BMI classification, smoking, prescriptions for antiepileptics or antipsychotics, year, region of residence, socioeconomic status, or having received advice on weight management or diet. They also accounted for diabetes, coronary heart disease, stroke, cancer, and depression diagnoses, and they eliminated the 280 days before a newborn delivery to account for pregnancy-related weight increases.
After adjustment for those potential confounders, people prescribed antidepressants were 21% more likely to experience substantial weight gain than those not prescribed them (adjusted rate ratio = 1.21; P less than .001). The researchers, cautioned, however, that residual confounding might have inflated the risk.
Those who had a normal weight when they began taking antidepressants had 29% greater risk of gaining enough weight to meet the criteria for overweight or obesity. Likewise, those already overweight when first prescribed antidepressants were 29% more likely to develop obesity.
For every 27 patients who took antidepressants for at least 1 year, 1 of them gained at least 5% in BMI during the subsequent year. Again, however, the researchers emphasized the absence of evidence for causality and the risk of bias from confounding.
Mirtazapine was the antidepressant associated with the highest incidence ratio of weight gain, but that drug was prescribed infrequently.
“From a clinical perspective, these observations reinforce the need for active body weight management to accompany widespread antidepressant treatment, although this might often be met with limited success,” the authors wrote.
The research was funded by the National Health Service Foundation Trust and by King’s College London. Aside from one author’s employment with the U.K. Clinical Practice Research Datalink data source, the authors had no disclosures.
SOURCE: Gafoor R et al. BMJ. 2018;361:k1951. doi: 10.1136/bmj.k1951.
FROM THE BMJ
Key clinical point: “These observations reinforce the need for active body weight management to accompany widespread antidepressant treatment.”
Major finding: People taking antidepressants had 21% higher risk of gaining at least 5% in body mass index and 29% greater risk of moving into a higher BMI category.
Study details: The findings are based on analysis of 10-year follow-up date from a British population-based cohort of 294,719 men and women, 18% of whom had been prescribed antidepressants.
Disclosures: The research was funded by the National Health Service Foundation Trust and by King’s College London. Aside from one author’s employment with the U.K. Clinical Practice Research Datalink data source, the authors had no disclosures.
Source: Gafoor R et al. BMJ. 2018;361:k1951. doi: 10.1136/bmj.k1951.
GDM, subsequent diabetes predictive of later renal damage
Women with a history of gestational diabetes mellitus who later develop diabetes had an elevated urinary albumin-to-creatinine ratio an average of 13 years later, indicating renal damage, according to a new study.
Those with a history of gestational diabetes mellitus (GDM) – but no subsequent development of diabetes – did not show an increased urinary albumin-to-creatinine ratio (UACR) but did have a higher estimated glomerular filtration rate (eGFR), hinting at early stages of glomerular hyperfiltration and renal damage.
“Our findings suggest that in women with a history of GDM, deterioration of renal function may potentially precede the development of overt diabetes, although clinically relevant outcomes such as elevated UACR may manifest only after progression to diabetes,” wrote Shristi Rawal, PhD, a postdoctoral fellow at the National Institute of Child Health and Human Development and her associates.
“These findings suggest that women with GDM-complicated pregnancies may represent a high-risk group that could benefit from regular monitoring for early-stage renal damage, timely detection of which may help clinicians initiate treatment to prevent or delay further disease progression,” they wrote.
The investigators compared outcomes among 1,226 Danish women 9-16 years after their index pregnancy during 1996-2002; a predominantly white study population, which limited the study’s generalizability to other demographic groups, the authors acknowledged. A total of 607 women had had GDM during their first pregnancy, 183 of whom developed type 1 or 2 diabetes. Of the 619 women who did not have GDM, 9 developed diabetes.
Serum creatinine and urinary albumin and creatinine measurements were taken to determine eGFR and UACR. Women with a previous GDM diagnosis had higher eGFR and UACR than women without previous GDM. The higher eGFR remained significant after adjustments for age at first pregnancy, completion of high school, smoking during pregnancy, a family history of diabetes, prepregnancy hypertension, and prepregnancy body mass index (BMI). UACR differences were not significant after adjustment.
Women with GDM and subsequent diabetes had a significantly higher UACR than women without either and had more than twice the risk of an elevated UACR of at least 20 mg/g (adjusted relative risk, 2.3), even after confounder adjustment.
The association with increased UACR was significant with the combination of a GDM history and a subsequent diabetes diagnosis, but not individually. The increased eGFR, however, remained significant after adjustment even for women with only a history of GDM, regardless of whether they later developed diabetes or even prediabetes.
“The independent association of GDM with eGFR also remained significant when we excluded women with conditions that might influence renal function markers at follow-up, including type 1 diabetes, preeclampsia/eclampsia or any hypertension complication during the index pregnancy, regular use of cholesterol-lowering drugs, or recent use of ACE inhibitors, diuretics, or H2 blockers,” the authors reported.
“Furthermore, no effect modification was observed when we stratified the analyses by clinical and lifestyle characteristics at follow-up, including current BMI, smoking, antihypertension medication use, family history of diabetes, physical activity, and median time since index pregnancy. Associations in some strata became statistically insignificant due to reduced sample size [all P for interaction = .05],” they wrote.
The research was funded by the National Institute of Child Health and Human Development at the National Institutes of Health, the Innovation Fund Denmark, March of Dimes Birth Defects Foundation, Health Foundation, Heart Foundation and European Union.
Coauthor Allan Vaag, MD, PhD is a vice president at AstraZeneca. No other authors had disclosures.
SOURCE: Rawal S et al. Diabetes Care. 2018 May 4. doi: 10.2337/dc17-2629.
Women with a history of gestational diabetes mellitus who later develop diabetes had an elevated urinary albumin-to-creatinine ratio an average of 13 years later, indicating renal damage, according to a new study.
Those with a history of gestational diabetes mellitus (GDM) – but no subsequent development of diabetes – did not show an increased urinary albumin-to-creatinine ratio (UACR) but did have a higher estimated glomerular filtration rate (eGFR), hinting at early stages of glomerular hyperfiltration and renal damage.
“Our findings suggest that in women with a history of GDM, deterioration of renal function may potentially precede the development of overt diabetes, although clinically relevant outcomes such as elevated UACR may manifest only after progression to diabetes,” wrote Shristi Rawal, PhD, a postdoctoral fellow at the National Institute of Child Health and Human Development and her associates.
“These findings suggest that women with GDM-complicated pregnancies may represent a high-risk group that could benefit from regular monitoring for early-stage renal damage, timely detection of which may help clinicians initiate treatment to prevent or delay further disease progression,” they wrote.
The investigators compared outcomes among 1,226 Danish women 9-16 years after their index pregnancy during 1996-2002; a predominantly white study population, which limited the study’s generalizability to other demographic groups, the authors acknowledged. A total of 607 women had had GDM during their first pregnancy, 183 of whom developed type 1 or 2 diabetes. Of the 619 women who did not have GDM, 9 developed diabetes.
Serum creatinine and urinary albumin and creatinine measurements were taken to determine eGFR and UACR. Women with a previous GDM diagnosis had higher eGFR and UACR than women without previous GDM. The higher eGFR remained significant after adjustments for age at first pregnancy, completion of high school, smoking during pregnancy, a family history of diabetes, prepregnancy hypertension, and prepregnancy body mass index (BMI). UACR differences were not significant after adjustment.
Women with GDM and subsequent diabetes had a significantly higher UACR than women without either and had more than twice the risk of an elevated UACR of at least 20 mg/g (adjusted relative risk, 2.3), even after confounder adjustment.
The association with increased UACR was significant with the combination of a GDM history and a subsequent diabetes diagnosis, but not individually. The increased eGFR, however, remained significant after adjustment even for women with only a history of GDM, regardless of whether they later developed diabetes or even prediabetes.
“The independent association of GDM with eGFR also remained significant when we excluded women with conditions that might influence renal function markers at follow-up, including type 1 diabetes, preeclampsia/eclampsia or any hypertension complication during the index pregnancy, regular use of cholesterol-lowering drugs, or recent use of ACE inhibitors, diuretics, or H2 blockers,” the authors reported.
“Furthermore, no effect modification was observed when we stratified the analyses by clinical and lifestyle characteristics at follow-up, including current BMI, smoking, antihypertension medication use, family history of diabetes, physical activity, and median time since index pregnancy. Associations in some strata became statistically insignificant due to reduced sample size [all P for interaction = .05],” they wrote.
The research was funded by the National Institute of Child Health and Human Development at the National Institutes of Health, the Innovation Fund Denmark, March of Dimes Birth Defects Foundation, Health Foundation, Heart Foundation and European Union.
Coauthor Allan Vaag, MD, PhD is a vice president at AstraZeneca. No other authors had disclosures.
SOURCE: Rawal S et al. Diabetes Care. 2018 May 4. doi: 10.2337/dc17-2629.
Women with a history of gestational diabetes mellitus who later develop diabetes had an elevated urinary albumin-to-creatinine ratio an average of 13 years later, indicating renal damage, according to a new study.
Those with a history of gestational diabetes mellitus (GDM) – but no subsequent development of diabetes – did not show an increased urinary albumin-to-creatinine ratio (UACR) but did have a higher estimated glomerular filtration rate (eGFR), hinting at early stages of glomerular hyperfiltration and renal damage.
“Our findings suggest that in women with a history of GDM, deterioration of renal function may potentially precede the development of overt diabetes, although clinically relevant outcomes such as elevated UACR may manifest only after progression to diabetes,” wrote Shristi Rawal, PhD, a postdoctoral fellow at the National Institute of Child Health and Human Development and her associates.
“These findings suggest that women with GDM-complicated pregnancies may represent a high-risk group that could benefit from regular monitoring for early-stage renal damage, timely detection of which may help clinicians initiate treatment to prevent or delay further disease progression,” they wrote.
The investigators compared outcomes among 1,226 Danish women 9-16 years after their index pregnancy during 1996-2002; a predominantly white study population, which limited the study’s generalizability to other demographic groups, the authors acknowledged. A total of 607 women had had GDM during their first pregnancy, 183 of whom developed type 1 or 2 diabetes. Of the 619 women who did not have GDM, 9 developed diabetes.
Serum creatinine and urinary albumin and creatinine measurements were taken to determine eGFR and UACR. Women with a previous GDM diagnosis had higher eGFR and UACR than women without previous GDM. The higher eGFR remained significant after adjustments for age at first pregnancy, completion of high school, smoking during pregnancy, a family history of diabetes, prepregnancy hypertension, and prepregnancy body mass index (BMI). UACR differences were not significant after adjustment.
Women with GDM and subsequent diabetes had a significantly higher UACR than women without either and had more than twice the risk of an elevated UACR of at least 20 mg/g (adjusted relative risk, 2.3), even after confounder adjustment.
The association with increased UACR was significant with the combination of a GDM history and a subsequent diabetes diagnosis, but not individually. The increased eGFR, however, remained significant after adjustment even for women with only a history of GDM, regardless of whether they later developed diabetes or even prediabetes.
“The independent association of GDM with eGFR also remained significant when we excluded women with conditions that might influence renal function markers at follow-up, including type 1 diabetes, preeclampsia/eclampsia or any hypertension complication during the index pregnancy, regular use of cholesterol-lowering drugs, or recent use of ACE inhibitors, diuretics, or H2 blockers,” the authors reported.
“Furthermore, no effect modification was observed when we stratified the analyses by clinical and lifestyle characteristics at follow-up, including current BMI, smoking, antihypertension medication use, family history of diabetes, physical activity, and median time since index pregnancy. Associations in some strata became statistically insignificant due to reduced sample size [all P for interaction = .05],” they wrote.
The research was funded by the National Institute of Child Health and Human Development at the National Institutes of Health, the Innovation Fund Denmark, March of Dimes Birth Defects Foundation, Health Foundation, Heart Foundation and European Union.
Coauthor Allan Vaag, MD, PhD is a vice president at AstraZeneca. No other authors had disclosures.
SOURCE: Rawal S et al. Diabetes Care. 2018 May 4. doi: 10.2337/dc17-2629.
FROM DIABETES CARE
Key clinical point: Gestational diabetes mellitus may be a risk factor for future development of renal damage.
Major finding: Women with previous GDM and a subsequent diagnosis of diabetes were over twice as likely to show evidence of existing renal damage.
Data source: The findings are based on 9-16 years of prospective follow-up of 607 women with and 619 women without a history of GDM.
Disclosures: The research was funded by the National Institute of Child Health and Human Development at the National Institutes of Health, the Innovation Fund Denmark, March of Dimes Birth Defects Foundation, Health Foundation, Heart Foundation and European Union. Coauthor Allan Vaag is an employee of AstraZeneca. No other authors had disclosures.
Source: Rawal S et al. Diabetes Care. 2018 May 4. doi: 10.2337/dc17-2629.
Autism screening tests fall short
Children whose autism was not detected by the Modified Checklist for Autism in Toddlers (M-CHAT) at 18 months old were more likely to have delays in social, communication, and fine and gross motor skills at the time of the screen, compared with other children who had negative results, according to findings from a retrospective analysis of 68,197 screen-negative cases in the Norwegian Mother and Child Cohort Study.
Parents of children with false-negative M-CHAT results rated their children’s gross and fine motor skills and social and communication skills at 18 months as less developed than did parents of children with true-negative screens. For girls who had false-negative results and were later diagnosed with autism, the delays were more pronounced, compared with girls with true-negative results. Also, girls later diagnosed with autism were rated as less shy than girls with true-negative scores. Shyness was more common in boys later diagnosed with autism than in boys with true-negative scores.
“When trying to determine if a young child is exhibiting autism symptoms, clinicians should not rely solely on a single instrument but consider parental concerns and draw on other developmental surveillance instruments, as well as their clinical judgment. ... The clinicians also need to be particularly wary about discounting symptoms of social difficulties in girls because they may be masked by limited shyness or social inhibition,” wrote Roald A. Øien, MA, of the University of Tromsø (Norway) and Yale University in New Haven, Conn., and his associates in Pediatrics.
The researchers noted that the study was based on use of a previous M-CHAT version. The findings may not be relevant to the updated M-CHAT-R/F, which has 20 questions, new cutoffs, and a recommended follow-up interview.
Of the Norwegian children who were at least 40 months old at the time of the study, 67,969 had true-negative M-CHAT screens, and 228 had false-negative screens based on later diagnoses reported in the Autism Birth Cohort, a substudy of the Norwegian Mother and Child Cohort Study.
The 18-month-olds had been assessed with the M-CHAT, selected items from the Ages and Stages Questionnaire and the Emotionality Activity Sociability Temperament Survey. Of the 23 pass-fail M-CHAT items, 6 are highly predictive of a later ASD diagnosis; a positive screen is failure of at least 2 of those 6 items.
Both boys and girls with false negatives were less social and had lower communication and gross motor skills, compared with their true-negative counterparts, but these differences were greater between false-negative and true-negative girls. Fine motor skills were also significantly lower in those with false negatives than in those with true negatives, but the magnitude was no different between girls and boys.
Overall, boys had more advanced gross motor skills and higher activity levels than girls, independent of true- or false-negative status.
In post hoc analyses, boys with false-negative results were rated as more shy than boys with true-negative results. Girls with false negatives were rated as less shy than girls with true negatives and boys with false negatives. Ratings of emotionality and activity did not differ among the children with true or false negatives.
The authors speculated that girls with false negatives may have “somewhat lower levels of social fearfulness or lower inhibitory control, compared with boys.”
The authors also suggested possible reasons for the false negatives, including parents’ difficulty in matching behaviors described in the M-CHAT with their children’s behaviors and the lack of graded responses on the M-CHAT, which may influence parents’ responses.
By comparison, the Ages and Stages Questionnaire “gives parents the opportunity to express that the children exhibit skills occasionally albeit inconsistently, which may allow them to express their concerns and perceptions in a more graded manner,” the authors wrote.
Another possible reason for false negatives, the authors suggested, is that symptoms in those with autism spectrum disorder may manifest differently in early childhood, partly depending on the level of the child’s verbal and nonverbal skills.
“We believe that our results contribute, at a fundamental level, to our understanding of early screening for ASD, and we highlight the discrepancy between hard cutoff criteria for autism and the social-communicative, developmental, and temperamental signatures of emerging or subthreshold autism phenotypes,” the authors wrote. They noted a need for screens that take into account temperament and verbal and nonverbal skill levels.
The research was funded by the Norwegian Ministry of Health and Care Services, the Norwegian Ministry of Education and Research, the Research Council of Norway and Functional Genomics in Norway, the National Institute of Neurological Disorders and Stroke and the National Institute of Environmental Health Sciences. Dr Hornig coinvented an intestinal microbiome biomarker for autism which has patents assigned to Columbia University.
SOURCE: Øien RA et al. Pediatrics. 2018;141(6):e20173596.
The investigators’ conclusions that more sensitive autism spectrum disorders (ASD) screening tools are needed may need to be tempered.
The study authors conclude that, even among children who screen negative on the M-CHAT, those with ASD frequently display early signs and symptoms that, with more sensitive screening instruments, may enhance early detection.
While such a conclusion is logical, the study data indicate that the M-CHAT had a sensitivity of 23% in this population, which is dramatically lower than the sensitivity reported in other studies. If the sensitivity of the updated M-CHAT-R screening tool is truly 91%, as has been claimed, it is hard to argue that more sensitive screening tools are needed.
As the M-CHAT-R was developed to improve usability and decrease the false-positive rate of the M-CHAT, the difference in screening tools is unlikely to account for the low sensitivity of the M-CHAT in this population. Possibilities that may factor into the low sensitivity include timing (the M-CHATs were evaluated only at 18 months), differential follow-up across false- and true-negative screens, or population differences in the Norwegian study and previous work.
These criticisms withstanding, the current study does send a clear warning that the M-CHAT likely does not equally identify all manifestations, or clinical phenotypes, of ASD. The findings lend credence to the concern of the USPSTF (U.S. Preventive Services Task Force) that “clinical and convenience samples do not adequately demonstrate the psychometric properties of screeners in practice.” In this study, the researchers reinforce the notion that screened and clinical populations may be systematically different and that more research is needed to understand such differences.
This commentary is edited from an accompanying editorial in Pediatrics (2018;141[6]:e20180965) by Sarabeth Broder-Fingert, MD, MPH; Emily Feinberg, ScD; and Michael Silverstein, MD, MPH, of the Boston University/Boston Medical Center. Dr Silverstein is a member of the U.S. Preventive Services Task Force but speaks here for himself alone.
The investigators’ conclusions that more sensitive autism spectrum disorders (ASD) screening tools are needed may need to be tempered.
The study authors conclude that, even among children who screen negative on the M-CHAT, those with ASD frequently display early signs and symptoms that, with more sensitive screening instruments, may enhance early detection.
While such a conclusion is logical, the study data indicate that the M-CHAT had a sensitivity of 23% in this population, which is dramatically lower than the sensitivity reported in other studies. If the sensitivity of the updated M-CHAT-R screening tool is truly 91%, as has been claimed, it is hard to argue that more sensitive screening tools are needed.
As the M-CHAT-R was developed to improve usability and decrease the false-positive rate of the M-CHAT, the difference in screening tools is unlikely to account for the low sensitivity of the M-CHAT in this population. Possibilities that may factor into the low sensitivity include timing (the M-CHATs were evaluated only at 18 months), differential follow-up across false- and true-negative screens, or population differences in the Norwegian study and previous work.
These criticisms withstanding, the current study does send a clear warning that the M-CHAT likely does not equally identify all manifestations, or clinical phenotypes, of ASD. The findings lend credence to the concern of the USPSTF (U.S. Preventive Services Task Force) that “clinical and convenience samples do not adequately demonstrate the psychometric properties of screeners in practice.” In this study, the researchers reinforce the notion that screened and clinical populations may be systematically different and that more research is needed to understand such differences.
This commentary is edited from an accompanying editorial in Pediatrics (2018;141[6]:e20180965) by Sarabeth Broder-Fingert, MD, MPH; Emily Feinberg, ScD; and Michael Silverstein, MD, MPH, of the Boston University/Boston Medical Center. Dr Silverstein is a member of the U.S. Preventive Services Task Force but speaks here for himself alone.
The investigators’ conclusions that more sensitive autism spectrum disorders (ASD) screening tools are needed may need to be tempered.
The study authors conclude that, even among children who screen negative on the M-CHAT, those with ASD frequently display early signs and symptoms that, with more sensitive screening instruments, may enhance early detection.
While such a conclusion is logical, the study data indicate that the M-CHAT had a sensitivity of 23% in this population, which is dramatically lower than the sensitivity reported in other studies. If the sensitivity of the updated M-CHAT-R screening tool is truly 91%, as has been claimed, it is hard to argue that more sensitive screening tools are needed.
As the M-CHAT-R was developed to improve usability and decrease the false-positive rate of the M-CHAT, the difference in screening tools is unlikely to account for the low sensitivity of the M-CHAT in this population. Possibilities that may factor into the low sensitivity include timing (the M-CHATs were evaluated only at 18 months), differential follow-up across false- and true-negative screens, or population differences in the Norwegian study and previous work.
These criticisms withstanding, the current study does send a clear warning that the M-CHAT likely does not equally identify all manifestations, or clinical phenotypes, of ASD. The findings lend credence to the concern of the USPSTF (U.S. Preventive Services Task Force) that “clinical and convenience samples do not adequately demonstrate the psychometric properties of screeners in practice.” In this study, the researchers reinforce the notion that screened and clinical populations may be systematically different and that more research is needed to understand such differences.
This commentary is edited from an accompanying editorial in Pediatrics (2018;141[6]:e20180965) by Sarabeth Broder-Fingert, MD, MPH; Emily Feinberg, ScD; and Michael Silverstein, MD, MPH, of the Boston University/Boston Medical Center. Dr Silverstein is a member of the U.S. Preventive Services Task Force but speaks here for himself alone.
Children whose autism was not detected by the Modified Checklist for Autism in Toddlers (M-CHAT) at 18 months old were more likely to have delays in social, communication, and fine and gross motor skills at the time of the screen, compared with other children who had negative results, according to findings from a retrospective analysis of 68,197 screen-negative cases in the Norwegian Mother and Child Cohort Study.
Parents of children with false-negative M-CHAT results rated their children’s gross and fine motor skills and social and communication skills at 18 months as less developed than did parents of children with true-negative screens. For girls who had false-negative results and were later diagnosed with autism, the delays were more pronounced, compared with girls with true-negative results. Also, girls later diagnosed with autism were rated as less shy than girls with true-negative scores. Shyness was more common in boys later diagnosed with autism than in boys with true-negative scores.
“When trying to determine if a young child is exhibiting autism symptoms, clinicians should not rely solely on a single instrument but consider parental concerns and draw on other developmental surveillance instruments, as well as their clinical judgment. ... The clinicians also need to be particularly wary about discounting symptoms of social difficulties in girls because they may be masked by limited shyness or social inhibition,” wrote Roald A. Øien, MA, of the University of Tromsø (Norway) and Yale University in New Haven, Conn., and his associates in Pediatrics.
The researchers noted that the study was based on use of a previous M-CHAT version. The findings may not be relevant to the updated M-CHAT-R/F, which has 20 questions, new cutoffs, and a recommended follow-up interview.
Of the Norwegian children who were at least 40 months old at the time of the study, 67,969 had true-negative M-CHAT screens, and 228 had false-negative screens based on later diagnoses reported in the Autism Birth Cohort, a substudy of the Norwegian Mother and Child Cohort Study.
The 18-month-olds had been assessed with the M-CHAT, selected items from the Ages and Stages Questionnaire and the Emotionality Activity Sociability Temperament Survey. Of the 23 pass-fail M-CHAT items, 6 are highly predictive of a later ASD diagnosis; a positive screen is failure of at least 2 of those 6 items.
Both boys and girls with false negatives were less social and had lower communication and gross motor skills, compared with their true-negative counterparts, but these differences were greater between false-negative and true-negative girls. Fine motor skills were also significantly lower in those with false negatives than in those with true negatives, but the magnitude was no different between girls and boys.
Overall, boys had more advanced gross motor skills and higher activity levels than girls, independent of true- or false-negative status.
In post hoc analyses, boys with false-negative results were rated as more shy than boys with true-negative results. Girls with false negatives were rated as less shy than girls with true negatives and boys with false negatives. Ratings of emotionality and activity did not differ among the children with true or false negatives.
The authors speculated that girls with false negatives may have “somewhat lower levels of social fearfulness or lower inhibitory control, compared with boys.”
The authors also suggested possible reasons for the false negatives, including parents’ difficulty in matching behaviors described in the M-CHAT with their children’s behaviors and the lack of graded responses on the M-CHAT, which may influence parents’ responses.
By comparison, the Ages and Stages Questionnaire “gives parents the opportunity to express that the children exhibit skills occasionally albeit inconsistently, which may allow them to express their concerns and perceptions in a more graded manner,” the authors wrote.
Another possible reason for false negatives, the authors suggested, is that symptoms in those with autism spectrum disorder may manifest differently in early childhood, partly depending on the level of the child’s verbal and nonverbal skills.
“We believe that our results contribute, at a fundamental level, to our understanding of early screening for ASD, and we highlight the discrepancy between hard cutoff criteria for autism and the social-communicative, developmental, and temperamental signatures of emerging or subthreshold autism phenotypes,” the authors wrote. They noted a need for screens that take into account temperament and verbal and nonverbal skill levels.
The research was funded by the Norwegian Ministry of Health and Care Services, the Norwegian Ministry of Education and Research, the Research Council of Norway and Functional Genomics in Norway, the National Institute of Neurological Disorders and Stroke and the National Institute of Environmental Health Sciences. Dr Hornig coinvented an intestinal microbiome biomarker for autism which has patents assigned to Columbia University.
SOURCE: Øien RA et al. Pediatrics. 2018;141(6):e20173596.
Children whose autism was not detected by the Modified Checklist for Autism in Toddlers (M-CHAT) at 18 months old were more likely to have delays in social, communication, and fine and gross motor skills at the time of the screen, compared with other children who had negative results, according to findings from a retrospective analysis of 68,197 screen-negative cases in the Norwegian Mother and Child Cohort Study.
Parents of children with false-negative M-CHAT results rated their children’s gross and fine motor skills and social and communication skills at 18 months as less developed than did parents of children with true-negative screens. For girls who had false-negative results and were later diagnosed with autism, the delays were more pronounced, compared with girls with true-negative results. Also, girls later diagnosed with autism were rated as less shy than girls with true-negative scores. Shyness was more common in boys later diagnosed with autism than in boys with true-negative scores.
“When trying to determine if a young child is exhibiting autism symptoms, clinicians should not rely solely on a single instrument but consider parental concerns and draw on other developmental surveillance instruments, as well as their clinical judgment. ... The clinicians also need to be particularly wary about discounting symptoms of social difficulties in girls because they may be masked by limited shyness or social inhibition,” wrote Roald A. Øien, MA, of the University of Tromsø (Norway) and Yale University in New Haven, Conn., and his associates in Pediatrics.
The researchers noted that the study was based on use of a previous M-CHAT version. The findings may not be relevant to the updated M-CHAT-R/F, which has 20 questions, new cutoffs, and a recommended follow-up interview.
Of the Norwegian children who were at least 40 months old at the time of the study, 67,969 had true-negative M-CHAT screens, and 228 had false-negative screens based on later diagnoses reported in the Autism Birth Cohort, a substudy of the Norwegian Mother and Child Cohort Study.
The 18-month-olds had been assessed with the M-CHAT, selected items from the Ages and Stages Questionnaire and the Emotionality Activity Sociability Temperament Survey. Of the 23 pass-fail M-CHAT items, 6 are highly predictive of a later ASD diagnosis; a positive screen is failure of at least 2 of those 6 items.
Both boys and girls with false negatives were less social and had lower communication and gross motor skills, compared with their true-negative counterparts, but these differences were greater between false-negative and true-negative girls. Fine motor skills were also significantly lower in those with false negatives than in those with true negatives, but the magnitude was no different between girls and boys.
Overall, boys had more advanced gross motor skills and higher activity levels than girls, independent of true- or false-negative status.
In post hoc analyses, boys with false-negative results were rated as more shy than boys with true-negative results. Girls with false negatives were rated as less shy than girls with true negatives and boys with false negatives. Ratings of emotionality and activity did not differ among the children with true or false negatives.
The authors speculated that girls with false negatives may have “somewhat lower levels of social fearfulness or lower inhibitory control, compared with boys.”
The authors also suggested possible reasons for the false negatives, including parents’ difficulty in matching behaviors described in the M-CHAT with their children’s behaviors and the lack of graded responses on the M-CHAT, which may influence parents’ responses.
By comparison, the Ages and Stages Questionnaire “gives parents the opportunity to express that the children exhibit skills occasionally albeit inconsistently, which may allow them to express their concerns and perceptions in a more graded manner,” the authors wrote.
Another possible reason for false negatives, the authors suggested, is that symptoms in those with autism spectrum disorder may manifest differently in early childhood, partly depending on the level of the child’s verbal and nonverbal skills.
“We believe that our results contribute, at a fundamental level, to our understanding of early screening for ASD, and we highlight the discrepancy between hard cutoff criteria for autism and the social-communicative, developmental, and temperamental signatures of emerging or subthreshold autism phenotypes,” the authors wrote. They noted a need for screens that take into account temperament and verbal and nonverbal skill levels.
The research was funded by the Norwegian Ministry of Health and Care Services, the Norwegian Ministry of Education and Research, the Research Council of Norway and Functional Genomics in Norway, the National Institute of Neurological Disorders and Stroke and the National Institute of Environmental Health Sciences. Dr Hornig coinvented an intestinal microbiome biomarker for autism which has patents assigned to Columbia University.
SOURCE: Øien RA et al. Pediatrics. 2018;141(6):e20173596.
FROM PEDIATRICS
Key clinical point: Despite false negatives on the M-CHAT autism screen, 18-month-olds showed delays in multiple domains.
Major finding: Children with autism screening false negatives had lower social, communication and motor skills at 18 months old than children with true negatives, particularly among girls.
Data source: The findings are based on a retrospective analysis of 68,197 of negative screens on the M-CHAT among Norwegian 18-month-olds.
Disclosures: The research was funded by the Norwegian Ministry of Health and Care Services, the Norwegian Ministry of Education and Research, the Research Council of Norway, Functional Genomics in Norway, the National Institute of Neurological Disorders and Stroke, and the National Institute of Environmental Health Sciences. Dr. Hornig coinvented an intestinal microbiome biomarker test for autism which has patents assigned to Columbia University, New York.
Source: Øien RA et al. Pediatrics. 2018;141(6):e20173596.
Too few Michigan children with SCD receive pneumococcal, meningococcal vaccines
Substantial percentages of children with sickle cell disease are not receiving certain recommended vaccines on time or at all, found a study examining receipt of pneumococcal and meningococcal vaccines among children born in Michigan.
Although these children were more likely to be up-to-date on their pneumococcal vaccines than others their age without sickle cell disease (SCD), nearly one-third had not received all their pneumococcal vaccines by 36 months old. These children are at higher risk of meningococcal and invasive pneumococcal disease because they lack normal spleen function.
ACIP has recommended since February 2010 that all children receive the 13-valent pneumococcal conjugate vaccine (PCV13), which replaced the 7-valent pneumococcal conjugate vaccine (PCV7) that had been recommended since October 2000.
But ACIP also recommends that children with SCD receive two doses of the 23-valent polysaccharide vaccine (PPV23), starting at 2 years old. These children also should receive a PCV13 dose before age 18 years, even if they received the full PCV7 vaccine series.
“By directly including SCD status in a child’s immunization record, an immunization information system could use a specialized algorithm to indicate to healthcare providers which vaccines should be given to a patient with SCD, which may differ from a typical patient,” Dr. Wagner and his colleagues wrote in The Journal of Pediatrics.
“Educational campaigns targeted to parents of these children and their providers could also help advance the importance of vaccination, particularly as more vaccines enter the market, many of which may be highly recommended for children with SCD,” they said.
The researchers matched 1,022 children with SCD to 3,725 children without SCD based on age, sex, race, and zip code. The data was based on the Michigan Care Improvement Registry (MCIR), Michigan Vital Records live birth file, and the Michigan Newborn Screening Program for children born in the state between April 1, 1995, and January 1, 2014.
At age 36 months, 69% of children with SCD had been fully vaccinated with the pneumococcal conjugate vaccine series, compared with 45% of children without SCD. The meningococcal vaccine had been administered to 59% of children with SCD.
Children with SCD were more likely than those without the disease to be up-to-date on their pneumococcal vaccine(s) at 5, 7 and 16 months old.
Nevertheless, substantial percentages of children with SCD who received the complete series of the 7-valent pneumococcal conjugate vaccine had not received two other pneumococcal vaccines. Just over 29% were missing a dose of PCV13, 21.8% of children over 2 years old had not received any dose of PPV23, and 50.7% had not received a second dose of PPV23 by the age of 10 years.
The authors drew attention to the complexity of ACIP recommendations, however: ACIP released 7 recommendations a year, on average, between 2006 and 2015.
“Although providers have a responsibility to educate themselves on how best to protect children with high-risk conditions, these figures speak to the need for MCIR, the state’s immunization information system, to provide additional information on children, such as those who have sickle cell disease, who have special vaccination recommendations,” the authors wrote.
The authors reported no conflicts of interest. No external funding was noted.
SOURCE: Wagner AL et al. J Pediatr. J Pediatr. 2018 May;196:223-9.
This study is particularly valuable because of the “depth, breadth and completeness” of data from across an entire state, a control group that is socioeconomically matched, and a study that was done during a time when new, life-saving vaccines were licensed and recommended. The many changes in the recommendations because of new vaccines and new understanding of the best use of these vaccines make for a complex schedule, but we health care providers need to keep current and to educate parents so their children are protected against infectious diseases. For parents of children with sickle cell disease, the schedule is more complex and the need is greater because of their extreme vulnerability. Wagner et al. suggest that “a proactive electronic prompt to providers [and parents] for vaccines needed for children with special conditions [as exists for the general immunization schedule] is needed – and seems doable.”
Sarah S. Long, MD, is a professor of pediatrics at Drexel University, Philadelphia. She is an associate editor of the Journal of Pediatrics and the Red Book Report of the Committee on Infectious Diseases of the American Academy of Pediatrics. She reported no disclosures. This is a summary of her editorial accompanying the article by Wagner et al. (J. Pediatr. 2018;196:3).
This study is particularly valuable because of the “depth, breadth and completeness” of data from across an entire state, a control group that is socioeconomically matched, and a study that was done during a time when new, life-saving vaccines were licensed and recommended. The many changes in the recommendations because of new vaccines and new understanding of the best use of these vaccines make for a complex schedule, but we health care providers need to keep current and to educate parents so their children are protected against infectious diseases. For parents of children with sickle cell disease, the schedule is more complex and the need is greater because of their extreme vulnerability. Wagner et al. suggest that “a proactive electronic prompt to providers [and parents] for vaccines needed for children with special conditions [as exists for the general immunization schedule] is needed – and seems doable.”
Sarah S. Long, MD, is a professor of pediatrics at Drexel University, Philadelphia. She is an associate editor of the Journal of Pediatrics and the Red Book Report of the Committee on Infectious Diseases of the American Academy of Pediatrics. She reported no disclosures. This is a summary of her editorial accompanying the article by Wagner et al. (J. Pediatr. 2018;196:3).
This study is particularly valuable because of the “depth, breadth and completeness” of data from across an entire state, a control group that is socioeconomically matched, and a study that was done during a time when new, life-saving vaccines were licensed and recommended. The many changes in the recommendations because of new vaccines and new understanding of the best use of these vaccines make for a complex schedule, but we health care providers need to keep current and to educate parents so their children are protected against infectious diseases. For parents of children with sickle cell disease, the schedule is more complex and the need is greater because of their extreme vulnerability. Wagner et al. suggest that “a proactive electronic prompt to providers [and parents] for vaccines needed for children with special conditions [as exists for the general immunization schedule] is needed – and seems doable.”
Sarah S. Long, MD, is a professor of pediatrics at Drexel University, Philadelphia. She is an associate editor of the Journal of Pediatrics and the Red Book Report of the Committee on Infectious Diseases of the American Academy of Pediatrics. She reported no disclosures. This is a summary of her editorial accompanying the article by Wagner et al. (J. Pediatr. 2018;196:3).
Substantial percentages of children with sickle cell disease are not receiving certain recommended vaccines on time or at all, found a study examining receipt of pneumococcal and meningococcal vaccines among children born in Michigan.
Although these children were more likely to be up-to-date on their pneumococcal vaccines than others their age without sickle cell disease (SCD), nearly one-third had not received all their pneumococcal vaccines by 36 months old. These children are at higher risk of meningococcal and invasive pneumococcal disease because they lack normal spleen function.
ACIP has recommended since February 2010 that all children receive the 13-valent pneumococcal conjugate vaccine (PCV13), which replaced the 7-valent pneumococcal conjugate vaccine (PCV7) that had been recommended since October 2000.
But ACIP also recommends that children with SCD receive two doses of the 23-valent polysaccharide vaccine (PPV23), starting at 2 years old. These children also should receive a PCV13 dose before age 18 years, even if they received the full PCV7 vaccine series.
“By directly including SCD status in a child’s immunization record, an immunization information system could use a specialized algorithm to indicate to healthcare providers which vaccines should be given to a patient with SCD, which may differ from a typical patient,” Dr. Wagner and his colleagues wrote in The Journal of Pediatrics.
“Educational campaigns targeted to parents of these children and their providers could also help advance the importance of vaccination, particularly as more vaccines enter the market, many of which may be highly recommended for children with SCD,” they said.
The researchers matched 1,022 children with SCD to 3,725 children without SCD based on age, sex, race, and zip code. The data was based on the Michigan Care Improvement Registry (MCIR), Michigan Vital Records live birth file, and the Michigan Newborn Screening Program for children born in the state between April 1, 1995, and January 1, 2014.
At age 36 months, 69% of children with SCD had been fully vaccinated with the pneumococcal conjugate vaccine series, compared with 45% of children without SCD. The meningococcal vaccine had been administered to 59% of children with SCD.
Children with SCD were more likely than those without the disease to be up-to-date on their pneumococcal vaccine(s) at 5, 7 and 16 months old.
Nevertheless, substantial percentages of children with SCD who received the complete series of the 7-valent pneumococcal conjugate vaccine had not received two other pneumococcal vaccines. Just over 29% were missing a dose of PCV13, 21.8% of children over 2 years old had not received any dose of PPV23, and 50.7% had not received a second dose of PPV23 by the age of 10 years.
The authors drew attention to the complexity of ACIP recommendations, however: ACIP released 7 recommendations a year, on average, between 2006 and 2015.
“Although providers have a responsibility to educate themselves on how best to protect children with high-risk conditions, these figures speak to the need for MCIR, the state’s immunization information system, to provide additional information on children, such as those who have sickle cell disease, who have special vaccination recommendations,” the authors wrote.
The authors reported no conflicts of interest. No external funding was noted.
SOURCE: Wagner AL et al. J Pediatr. J Pediatr. 2018 May;196:223-9.
Substantial percentages of children with sickle cell disease are not receiving certain recommended vaccines on time or at all, found a study examining receipt of pneumococcal and meningococcal vaccines among children born in Michigan.
Although these children were more likely to be up-to-date on their pneumococcal vaccines than others their age without sickle cell disease (SCD), nearly one-third had not received all their pneumococcal vaccines by 36 months old. These children are at higher risk of meningococcal and invasive pneumococcal disease because they lack normal spleen function.
ACIP has recommended since February 2010 that all children receive the 13-valent pneumococcal conjugate vaccine (PCV13), which replaced the 7-valent pneumococcal conjugate vaccine (PCV7) that had been recommended since October 2000.
But ACIP also recommends that children with SCD receive two doses of the 23-valent polysaccharide vaccine (PPV23), starting at 2 years old. These children also should receive a PCV13 dose before age 18 years, even if they received the full PCV7 vaccine series.
“By directly including SCD status in a child’s immunization record, an immunization information system could use a specialized algorithm to indicate to healthcare providers which vaccines should be given to a patient with SCD, which may differ from a typical patient,” Dr. Wagner and his colleagues wrote in The Journal of Pediatrics.
“Educational campaigns targeted to parents of these children and their providers could also help advance the importance of vaccination, particularly as more vaccines enter the market, many of which may be highly recommended for children with SCD,” they said.
The researchers matched 1,022 children with SCD to 3,725 children without SCD based on age, sex, race, and zip code. The data was based on the Michigan Care Improvement Registry (MCIR), Michigan Vital Records live birth file, and the Michigan Newborn Screening Program for children born in the state between April 1, 1995, and January 1, 2014.
At age 36 months, 69% of children with SCD had been fully vaccinated with the pneumococcal conjugate vaccine series, compared with 45% of children without SCD. The meningococcal vaccine had been administered to 59% of children with SCD.
Children with SCD were more likely than those without the disease to be up-to-date on their pneumococcal vaccine(s) at 5, 7 and 16 months old.
Nevertheless, substantial percentages of children with SCD who received the complete series of the 7-valent pneumococcal conjugate vaccine had not received two other pneumococcal vaccines. Just over 29% were missing a dose of PCV13, 21.8% of children over 2 years old had not received any dose of PPV23, and 50.7% had not received a second dose of PPV23 by the age of 10 years.
The authors drew attention to the complexity of ACIP recommendations, however: ACIP released 7 recommendations a year, on average, between 2006 and 2015.
“Although providers have a responsibility to educate themselves on how best to protect children with high-risk conditions, these figures speak to the need for MCIR, the state’s immunization information system, to provide additional information on children, such as those who have sickle cell disease, who have special vaccination recommendations,” the authors wrote.
The authors reported no conflicts of interest. No external funding was noted.
SOURCE: Wagner AL et al. J Pediatr. J Pediatr. 2018 May;196:223-9.
Key clinical point: Too few children with sickle cell disease (SCD) are receiving Advisory Committee on Immunization Practices–recommended meningococcal and pneumococcal vaccines, including PCV13 and PPSV23.
Major finding:
Study details: The findings are based on a cohort study of children with and without SCD born in Michigan between April 1, 1995, and January 1, 2014.
Disclosures: The authors reported no conflicts of interest. No external funding was noted.
Source: Wagner AL et al. J Pediatr. 2018 May;196:223-9.
Vehicle crash risk linked to various sleep disorders
Individuals with certain sleeping disorders may have a higher risk of crashes, near-crashes or unsafe maneuvering prior to such events, suggests a study.
“The results confirm that some sleep disorders generally increase driving risk as defined by our dependent measures,” wrote Shu-Yuan Liu, a doctoral student, and two colleagues at Virginia Tech, Blacksburg (Sleep. 2018 Apr 1. doi: 10.1093/sleep/zsy023). “Furthermore, the results also provide some insights into how risk varies across specific types of sleep disorder and some moderating factors.”
The study involved licensed drivers who drove at least 3 days a week, had an eligible vehicle in good working condition, and agreed to participate for 1 to 2 years. At the start and end of the study, participants filled out a questionnaire on any medical conditions they had or had been treated for in the past year, any medications they were taking, and any aids they were using for a medical condition.
Among the conditions they were able to select were narcolepsy, sleep apnea, insomnia, shift work sleep disorder, restless legs syndrome (RLS), periodic limb movement disorder, and migraine. All of these conditions have been linked in previous studies to a higher risk of vehicle collisions.
A total of 646 participants, 18.2% of the sample, had one of those disorders: 0.14% had narcolepsy, 7.4% had sleep apnea, 4.8% had insomnia, 3.4% had RLS, 0.37% had shift work sleep disorder, 0.23% had periodic limb movement disorder, and 8.4% had migraine.
Analysis of vehicle data found that female drivers with RLS and any drivers with insomnia had a higher risk of crashes or near-crashes (adjusted odds ratio [AOR] = 2.26 and 1.49, respectively, P less than .05 for both). Drivers with narcolepsy had 9 times greater odds of being involved in a crash or near-crash, but the finding was not statistically significant (AOR = 10.24, P less than .1).
“Drivers who reported frequency of sleepy driving as ‘never,’ ‘rarely,’ and ‘sometimes’ also had higher a risk, indicating that crash or near-crash risk is also associated with sources other than these sleeping disorders,” the authors noted. These drivers’ increased odds of getting into or nearly getting into a crash ranged from 31% to 53% greater (P less than .05).
All drivers with shift work sleep disorder, except for those aged 20-24, had a crash or near-crash rate that was 7.5 times greater than that of drivers without any sleeping disorders. The rate among drivers aged 20-24 with this disorder had a 90% lower rate (risk ratio [RR] = 0.1, P less than .05) compared with control drivers.
When the researchers analyzed the drivers’ maneuvers just before a crash or near-crash, they found females with sleep apnea had a 36% greater odds of doing an unsafe maneuver in crash/near-crash circumstances (AOR = 1.36). (AOR = 3.38 and 3.53, respectively, P less than .05).
The only drivers with a sleeping disorder who were more likely to be involved in crashes of greater severity were those with periodic limb movement disorder (AOR = 1.43, P less than .05).
However, young drivers, senior drivers, and nighttime drivers also all had higher odds of being involved in more severe crashes and in performing unsafe maneuvers prior to a crash or near-crash. Nighttime drivers seemed to be most at risk for these, and they were linked to having more than 5 times greater odds of unsafely maneuvering their vehicles prior to getting into a crash or near crash (AOR = 6.71, P less than .05).
“This is a strong piece of evidence that nighttime driving is less safe than daytime driving and limiting amount of nighttime driving could be one method to moderate road risk for some individuals,” the authors wrote.
The study’s limitations include its observational nature, low numbers of participants with several of the sleeping disorders (at levels below the disorder’s prevalence in the general population), and the complexities involved in what causes a crash or near crash.
One limitation of this study was that sleep hygiene and sleep quality were not examined, even though these might contribute significantly to roadway safety, the researchers noted. This study also did not take into account what medications or other treatment (such as continuous positive airway pressure for those with sleep apnea) the participants might be receiving for their condition.
The study’s implications include the need for physicians to advise patients with insomnia or females with sleep apnea to use caution while driving without “exaggerating risks that introduce undue fear to patients with other sleep disorders and thereby limiting mobility unnecessarily,” the authors wrote. The researchers also suggested that employers consider providing alternative transportation to shift workers and/or that insurance companies offer employers lower rates for offering such alternatives.
SOURCE: Liu Shu-Yuan et al. Sleep J. 2018 Apr 1. doi: 10.1093/sleep/zsy023.
Individuals with certain sleeping disorders may have a higher risk of crashes, near-crashes or unsafe maneuvering prior to such events, suggests a study.
“The results confirm that some sleep disorders generally increase driving risk as defined by our dependent measures,” wrote Shu-Yuan Liu, a doctoral student, and two colleagues at Virginia Tech, Blacksburg (Sleep. 2018 Apr 1. doi: 10.1093/sleep/zsy023). “Furthermore, the results also provide some insights into how risk varies across specific types of sleep disorder and some moderating factors.”
The study involved licensed drivers who drove at least 3 days a week, had an eligible vehicle in good working condition, and agreed to participate for 1 to 2 years. At the start and end of the study, participants filled out a questionnaire on any medical conditions they had or had been treated for in the past year, any medications they were taking, and any aids they were using for a medical condition.
Among the conditions they were able to select were narcolepsy, sleep apnea, insomnia, shift work sleep disorder, restless legs syndrome (RLS), periodic limb movement disorder, and migraine. All of these conditions have been linked in previous studies to a higher risk of vehicle collisions.
A total of 646 participants, 18.2% of the sample, had one of those disorders: 0.14% had narcolepsy, 7.4% had sleep apnea, 4.8% had insomnia, 3.4% had RLS, 0.37% had shift work sleep disorder, 0.23% had periodic limb movement disorder, and 8.4% had migraine.
Analysis of vehicle data found that female drivers with RLS and any drivers with insomnia had a higher risk of crashes or near-crashes (adjusted odds ratio [AOR] = 2.26 and 1.49, respectively, P less than .05 for both). Drivers with narcolepsy had 9 times greater odds of being involved in a crash or near-crash, but the finding was not statistically significant (AOR = 10.24, P less than .1).
“Drivers who reported frequency of sleepy driving as ‘never,’ ‘rarely,’ and ‘sometimes’ also had higher a risk, indicating that crash or near-crash risk is also associated with sources other than these sleeping disorders,” the authors noted. These drivers’ increased odds of getting into or nearly getting into a crash ranged from 31% to 53% greater (P less than .05).
All drivers with shift work sleep disorder, except for those aged 20-24, had a crash or near-crash rate that was 7.5 times greater than that of drivers without any sleeping disorders. The rate among drivers aged 20-24 with this disorder had a 90% lower rate (risk ratio [RR] = 0.1, P less than .05) compared with control drivers.
When the researchers analyzed the drivers’ maneuvers just before a crash or near-crash, they found females with sleep apnea had a 36% greater odds of doing an unsafe maneuver in crash/near-crash circumstances (AOR = 1.36). (AOR = 3.38 and 3.53, respectively, P less than .05).
The only drivers with a sleeping disorder who were more likely to be involved in crashes of greater severity were those with periodic limb movement disorder (AOR = 1.43, P less than .05).
However, young drivers, senior drivers, and nighttime drivers also all had higher odds of being involved in more severe crashes and in performing unsafe maneuvers prior to a crash or near-crash. Nighttime drivers seemed to be most at risk for these, and they were linked to having more than 5 times greater odds of unsafely maneuvering their vehicles prior to getting into a crash or near crash (AOR = 6.71, P less than .05).
“This is a strong piece of evidence that nighttime driving is less safe than daytime driving and limiting amount of nighttime driving could be one method to moderate road risk for some individuals,” the authors wrote.
The study’s limitations include its observational nature, low numbers of participants with several of the sleeping disorders (at levels below the disorder’s prevalence in the general population), and the complexities involved in what causes a crash or near crash.
One limitation of this study was that sleep hygiene and sleep quality were not examined, even though these might contribute significantly to roadway safety, the researchers noted. This study also did not take into account what medications or other treatment (such as continuous positive airway pressure for those with sleep apnea) the participants might be receiving for their condition.
The study’s implications include the need for physicians to advise patients with insomnia or females with sleep apnea to use caution while driving without “exaggerating risks that introduce undue fear to patients with other sleep disorders and thereby limiting mobility unnecessarily,” the authors wrote. The researchers also suggested that employers consider providing alternative transportation to shift workers and/or that insurance companies offer employers lower rates for offering such alternatives.
SOURCE: Liu Shu-Yuan et al. Sleep J. 2018 Apr 1. doi: 10.1093/sleep/zsy023.
Individuals with certain sleeping disorders may have a higher risk of crashes, near-crashes or unsafe maneuvering prior to such events, suggests a study.
“The results confirm that some sleep disorders generally increase driving risk as defined by our dependent measures,” wrote Shu-Yuan Liu, a doctoral student, and two colleagues at Virginia Tech, Blacksburg (Sleep. 2018 Apr 1. doi: 10.1093/sleep/zsy023). “Furthermore, the results also provide some insights into how risk varies across specific types of sleep disorder and some moderating factors.”
The study involved licensed drivers who drove at least 3 days a week, had an eligible vehicle in good working condition, and agreed to participate for 1 to 2 years. At the start and end of the study, participants filled out a questionnaire on any medical conditions they had or had been treated for in the past year, any medications they were taking, and any aids they were using for a medical condition.
Among the conditions they were able to select were narcolepsy, sleep apnea, insomnia, shift work sleep disorder, restless legs syndrome (RLS), periodic limb movement disorder, and migraine. All of these conditions have been linked in previous studies to a higher risk of vehicle collisions.
A total of 646 participants, 18.2% of the sample, had one of those disorders: 0.14% had narcolepsy, 7.4% had sleep apnea, 4.8% had insomnia, 3.4% had RLS, 0.37% had shift work sleep disorder, 0.23% had periodic limb movement disorder, and 8.4% had migraine.
Analysis of vehicle data found that female drivers with RLS and any drivers with insomnia had a higher risk of crashes or near-crashes (adjusted odds ratio [AOR] = 2.26 and 1.49, respectively, P less than .05 for both). Drivers with narcolepsy had 9 times greater odds of being involved in a crash or near-crash, but the finding was not statistically significant (AOR = 10.24, P less than .1).
“Drivers who reported frequency of sleepy driving as ‘never,’ ‘rarely,’ and ‘sometimes’ also had higher a risk, indicating that crash or near-crash risk is also associated with sources other than these sleeping disorders,” the authors noted. These drivers’ increased odds of getting into or nearly getting into a crash ranged from 31% to 53% greater (P less than .05).
All drivers with shift work sleep disorder, except for those aged 20-24, had a crash or near-crash rate that was 7.5 times greater than that of drivers without any sleeping disorders. The rate among drivers aged 20-24 with this disorder had a 90% lower rate (risk ratio [RR] = 0.1, P less than .05) compared with control drivers.
When the researchers analyzed the drivers’ maneuvers just before a crash or near-crash, they found females with sleep apnea had a 36% greater odds of doing an unsafe maneuver in crash/near-crash circumstances (AOR = 1.36). (AOR = 3.38 and 3.53, respectively, P less than .05).
The only drivers with a sleeping disorder who were more likely to be involved in crashes of greater severity were those with periodic limb movement disorder (AOR = 1.43, P less than .05).
However, young drivers, senior drivers, and nighttime drivers also all had higher odds of being involved in more severe crashes and in performing unsafe maneuvers prior to a crash or near-crash. Nighttime drivers seemed to be most at risk for these, and they were linked to having more than 5 times greater odds of unsafely maneuvering their vehicles prior to getting into a crash or near crash (AOR = 6.71, P less than .05).
“This is a strong piece of evidence that nighttime driving is less safe than daytime driving and limiting amount of nighttime driving could be one method to moderate road risk for some individuals,” the authors wrote.
The study’s limitations include its observational nature, low numbers of participants with several of the sleeping disorders (at levels below the disorder’s prevalence in the general population), and the complexities involved in what causes a crash or near crash.
One limitation of this study was that sleep hygiene and sleep quality were not examined, even though these might contribute significantly to roadway safety, the researchers noted. This study also did not take into account what medications or other treatment (such as continuous positive airway pressure for those with sleep apnea) the participants might be receiving for their condition.
The study’s implications include the need for physicians to advise patients with insomnia or females with sleep apnea to use caution while driving without “exaggerating risks that introduce undue fear to patients with other sleep disorders and thereby limiting mobility unnecessarily,” the authors wrote. The researchers also suggested that employers consider providing alternative transportation to shift workers and/or that insurance companies offer employers lower rates for offering such alternatives.
SOURCE: Liu Shu-Yuan et al. Sleep J. 2018 Apr 1. doi: 10.1093/sleep/zsy023.
FROM SLEEP
Key clinical point: Individuals with certain sleeping disorders may have a higher risk of crashes, near-crashes or unsafe maneuvering prior to such events.
Major finding: Drivers with insomnia and female drivers with sleep apnea have 49% and 126% greater odds, respectively, of a crash or near-crash.
Data source: The findings are based on an analysis of naturalistic driving data from 3,541 U.S. drivers between ages 16 and 98.
Disclosures: The data were provided by the Transportation Research Board of the National Academy of Sciences. No external funding was noted. The authors reported having no disclosures.
Source: Liu Shu-Yuan et al. Sleep J. 2018 Apr 1. doi: 10.1093/sleep/zsy023.
ACOG advises earlier, more comprehensive postpartum care
It’s time to introduce a new paradigm for comprehensive care of women’s physical and mental health in the 3 months after giving birth, according to the American College of Obstetricians and Gynecologists.
In their newly revised committee opinion on postpartum care, ACOG encouraged doctors to think of a woman’s immediate postpartum period as a “fourth trimester” during which better care for women may help reduce maternal deaths and morbidity. That care includes a 3-week postpartum visit and a more comprehensive one within 3 months post partum.
Despite common practices in many other cultures that provide intense, dedicated support to women during the 30-40 days after giving birth, U.S. women typically only see their ob.gyn. at a single 6-week postpartum visit and receive little to no other formal maternal support. Beyond that visit, U.S. postpartum care typically is fragmented and inconsistent, split sporadically among pediatric and maternal providers and with little support in the transition from inpatient to outpatient care, the committee wrote.
Further, 40% of women do not attend a postpartum visit at all, and more than half of maternal deaths occur after the baby’s birth. The committee aims to overhaul maternal care and potentially help reduce those numbers. That process begins with prenatal discussions about the mother’s transition to parenthood, caring for herself and her health, her reproductive life plans, her desires related to future children, the timing of future pregnancies, and appropriate contraceptive options and decisions.
“Underutilization of postpartum care impedes management of chronic health conditions and access to effective contraception, which increases the risk of short interval pregnancy and preterm birth,” the committee wrote. “Attendance rates are lower among populations with limited resources, which contributes to health disparities.”
Components of comprehensive postpartum care
ACOG recommends the prenatal preparation for the postpartum period include discussions about infant feeding, “baby blues,” postpartum emotional health, parenting challenges, postpartum recovery from birth, long-term management of chronic health conditions, choosing a primary care provider for the mother’s ongoing care, her reproductive desires and choices, and any concerns about interpersonal or partner violence.
Before giving birth, a woman should develop a postpartum care plan with her physician and assemble a care team that includes her primary care providers along with family and friends who can provide support. The plan should include contact information for questions and written instructions about postpartum visits and follow-up care.
Prenatal planning also provides an opportunity to discuss a woman’s breastfeeding plans, goals, and questions as well as common physical problems that women may experience in the weeks after giving birth, such as heavy bleeding, pain, physical exhaustion, and urinary incontinence.
Physicians should inform women of the risks and benefits of becoming pregnant within 18 months and advise them not to have pregnancy intervals of less than 6 months. They should also ensure women know all their contraceptive options and should provide any information necessary for women to determine which methods best meet her needs.
The committee recommended a postpartum visit within the first 3 weeks after birth, instead of the current “6-week check,” that is timed and tailored to each woman’s particular needs. This visit allows assessment of postpartum depression risk and/or treatment and discussion of breastfeeding goals and/or difficulties. Approximately one in five women who stopped breastfeeding earlier than they wanted to had ceased within first 6 weeks post partum.
Woman-centered follow-up should be tailored to women’s individual needs and include a comprehensive postpartum visit no later than 12 weeks after giving birth. The comprehensive visit should include a complete assessment of the woman’s physical, social, and psychological well-being, including discussion of “mood and emotional well-being, infant care and feeding, sexuality, contraception, birth spacing, sleep and fatigue, physical recovery from birth, chronic disease management, and health maintenance,” the committee wrote.
The comprehensive visit should include the following components:
- Postpartum depression and anxiety screening.
- Screening for tobacco use and substance use.
- Follow-up on preexisting mental and physical health conditions.
- Assessment of mother’s confidence and comfort with newborn care, including feeding method, childcare strategy, identification of the child’s medical home, and recommended immunizations for all caregivers.
- Comfort and confidence with breastfeeding and management of any challenges, such as breastfeeding-associated pain; logistics and legal rights after returning to work or school; and fertility and contraception with breastfeeding.
- Assessment of material needs, including housing, utilities, food, and diapers.
- Guidance on sexuality, dyspareunia, reproductive life plans, contraception, and management of recurrent pregnancy complications, such as daily low-dose aspirin to reduce preeclampsia risk and 17a-hydroxyprogesterone caproate to reduce recurrent preterm birth.
- Sleep, fatigue, and coping options.
- Physical recovery from birth, including assessment of urinary and fecal continence and guidance on physical activity and a healthy weight.
- Chronic disease management and long-term implications of those conditions.
- Health maintenance, including review of vaccination history, needed vaccinations, and well-woman screenings, including Pap test and pelvic examination as indicated.
“However timed, the comprehensive postpartum visit is a medical appointment; it is not an ‘all-clear’ signal,” the authors wrote. “Obstetrician-gynecologists and other obstetric care providers should ensure that women, their families, and their employers understand that completion of the comprehensive postpartum visit does not obviate the need for continued recovery and support through 6 weeks’ post partum and beyond.”
Women with comorbidities or adverse birth outcomes
Women who had gestational diabetes, gestational hypertension, preeclampsia, eclampsia, or a preterm birth should be informed of their increased lifetime risk of cardiovascular and metabolic disease, the committee recommended. Women who have experienced a miscarriage, stillbirth, or neonatal death should also follow up with their provider, who can offer resources for emotional support and bereavement counseling, referrals as needed, a review of any laboratory or pathology results related to the loss and counseling regarding future risks and pregnancies.
The committee recommended that women with chronic medical conditions follow up with their ob.gyn. or other primary care providers to ensure ongoing coordinated care for hypertension, obesity, diabetes, thyroid disorders, renal disease, mood disorders, substance use disorders, seizure disorders, and any other chronic issues. Care should include assessment of medications, including antiepileptics and psychotropic drugs, that may require adjustment for postpartum physiology and, if relevant, breastfeeding.
Since half of postpartum strokes occur within the first 10 days after discharge, ACOG recommends women with other hypertensive disorders of pregnancy have a postpartum visit within 7-10 days after birth to assess blood pressure. A follow-up visit should occur within 72 hours for those with severe hypertension.
ACOG also recommended early postpartum follow-up for women with increased risk of complications, including postpartum depression, cesarean or perennial wound infections, lactation difficulties, or chronic conditions.
The committee opinion concluded with a call for public policy changes, including endorsement of guaranteed 100% paid parental leave for a minimum of 6 weeks with full benefits. Currently, 23% of employed mothers return to work in the first 10 days after giving birth, and another 22% return within 10-30 days, the committee cited. Close to half of employed mothers therefore go back to work before the 6-week postpartum follow-up visit.
“Obstetrician-gynecologists and other obstetric care providers should be in the forefront of policy efforts to enable all women to recover from birth and nurture their infants,” the committee wrote.
The ACOG Presidential Task Force on Redefining the Postpartum Visit and the Committee on Obstetrics Practice developed the new clinical opinion, which is endorsed by the Academy of Breastfeeding Medicine, the American College of Nurse-Midwives, the National Association of Nurse Practitioners in Women’s Health, the Society for Academic Specialists in General Obstetrics and Gynecology, and the Society for Maternal-Fetal Medicine. The committee opinion did not require external funding, and the authors did not report any disclosures.
SOURCE: Obstet Gynecol 2018;131:e140-50.
It’s time to introduce a new paradigm for comprehensive care of women’s physical and mental health in the 3 months after giving birth, according to the American College of Obstetricians and Gynecologists.
In their newly revised committee opinion on postpartum care, ACOG encouraged doctors to think of a woman’s immediate postpartum period as a “fourth trimester” during which better care for women may help reduce maternal deaths and morbidity. That care includes a 3-week postpartum visit and a more comprehensive one within 3 months post partum.
Despite common practices in many other cultures that provide intense, dedicated support to women during the 30-40 days after giving birth, U.S. women typically only see their ob.gyn. at a single 6-week postpartum visit and receive little to no other formal maternal support. Beyond that visit, U.S. postpartum care typically is fragmented and inconsistent, split sporadically among pediatric and maternal providers and with little support in the transition from inpatient to outpatient care, the committee wrote.
Further, 40% of women do not attend a postpartum visit at all, and more than half of maternal deaths occur after the baby’s birth. The committee aims to overhaul maternal care and potentially help reduce those numbers. That process begins with prenatal discussions about the mother’s transition to parenthood, caring for herself and her health, her reproductive life plans, her desires related to future children, the timing of future pregnancies, and appropriate contraceptive options and decisions.
“Underutilization of postpartum care impedes management of chronic health conditions and access to effective contraception, which increases the risk of short interval pregnancy and preterm birth,” the committee wrote. “Attendance rates are lower among populations with limited resources, which contributes to health disparities.”
Components of comprehensive postpartum care
ACOG recommends the prenatal preparation for the postpartum period include discussions about infant feeding, “baby blues,” postpartum emotional health, parenting challenges, postpartum recovery from birth, long-term management of chronic health conditions, choosing a primary care provider for the mother’s ongoing care, her reproductive desires and choices, and any concerns about interpersonal or partner violence.
Before giving birth, a woman should develop a postpartum care plan with her physician and assemble a care team that includes her primary care providers along with family and friends who can provide support. The plan should include contact information for questions and written instructions about postpartum visits and follow-up care.
Prenatal planning also provides an opportunity to discuss a woman’s breastfeeding plans, goals, and questions as well as common physical problems that women may experience in the weeks after giving birth, such as heavy bleeding, pain, physical exhaustion, and urinary incontinence.
Physicians should inform women of the risks and benefits of becoming pregnant within 18 months and advise them not to have pregnancy intervals of less than 6 months. They should also ensure women know all their contraceptive options and should provide any information necessary for women to determine which methods best meet her needs.
The committee recommended a postpartum visit within the first 3 weeks after birth, instead of the current “6-week check,” that is timed and tailored to each woman’s particular needs. This visit allows assessment of postpartum depression risk and/or treatment and discussion of breastfeeding goals and/or difficulties. Approximately one in five women who stopped breastfeeding earlier than they wanted to had ceased within first 6 weeks post partum.
Woman-centered follow-up should be tailored to women’s individual needs and include a comprehensive postpartum visit no later than 12 weeks after giving birth. The comprehensive visit should include a complete assessment of the woman’s physical, social, and psychological well-being, including discussion of “mood and emotional well-being, infant care and feeding, sexuality, contraception, birth spacing, sleep and fatigue, physical recovery from birth, chronic disease management, and health maintenance,” the committee wrote.
The comprehensive visit should include the following components:
- Postpartum depression and anxiety screening.
- Screening for tobacco use and substance use.
- Follow-up on preexisting mental and physical health conditions.
- Assessment of mother’s confidence and comfort with newborn care, including feeding method, childcare strategy, identification of the child’s medical home, and recommended immunizations for all caregivers.
- Comfort and confidence with breastfeeding and management of any challenges, such as breastfeeding-associated pain; logistics and legal rights after returning to work or school; and fertility and contraception with breastfeeding.
- Assessment of material needs, including housing, utilities, food, and diapers.
- Guidance on sexuality, dyspareunia, reproductive life plans, contraception, and management of recurrent pregnancy complications, such as daily low-dose aspirin to reduce preeclampsia risk and 17a-hydroxyprogesterone caproate to reduce recurrent preterm birth.
- Sleep, fatigue, and coping options.
- Physical recovery from birth, including assessment of urinary and fecal continence and guidance on physical activity and a healthy weight.
- Chronic disease management and long-term implications of those conditions.
- Health maintenance, including review of vaccination history, needed vaccinations, and well-woman screenings, including Pap test and pelvic examination as indicated.
“However timed, the comprehensive postpartum visit is a medical appointment; it is not an ‘all-clear’ signal,” the authors wrote. “Obstetrician-gynecologists and other obstetric care providers should ensure that women, their families, and their employers understand that completion of the comprehensive postpartum visit does not obviate the need for continued recovery and support through 6 weeks’ post partum and beyond.”
Women with comorbidities or adverse birth outcomes
Women who had gestational diabetes, gestational hypertension, preeclampsia, eclampsia, or a preterm birth should be informed of their increased lifetime risk of cardiovascular and metabolic disease, the committee recommended. Women who have experienced a miscarriage, stillbirth, or neonatal death should also follow up with their provider, who can offer resources for emotional support and bereavement counseling, referrals as needed, a review of any laboratory or pathology results related to the loss and counseling regarding future risks and pregnancies.
The committee recommended that women with chronic medical conditions follow up with their ob.gyn. or other primary care providers to ensure ongoing coordinated care for hypertension, obesity, diabetes, thyroid disorders, renal disease, mood disorders, substance use disorders, seizure disorders, and any other chronic issues. Care should include assessment of medications, including antiepileptics and psychotropic drugs, that may require adjustment for postpartum physiology and, if relevant, breastfeeding.
Since half of postpartum strokes occur within the first 10 days after discharge, ACOG recommends women with other hypertensive disorders of pregnancy have a postpartum visit within 7-10 days after birth to assess blood pressure. A follow-up visit should occur within 72 hours for those with severe hypertension.
ACOG also recommended early postpartum follow-up for women with increased risk of complications, including postpartum depression, cesarean or perennial wound infections, lactation difficulties, or chronic conditions.
The committee opinion concluded with a call for public policy changes, including endorsement of guaranteed 100% paid parental leave for a minimum of 6 weeks with full benefits. Currently, 23% of employed mothers return to work in the first 10 days after giving birth, and another 22% return within 10-30 days, the committee cited. Close to half of employed mothers therefore go back to work before the 6-week postpartum follow-up visit.
“Obstetrician-gynecologists and other obstetric care providers should be in the forefront of policy efforts to enable all women to recover from birth and nurture their infants,” the committee wrote.
The ACOG Presidential Task Force on Redefining the Postpartum Visit and the Committee on Obstetrics Practice developed the new clinical opinion, which is endorsed by the Academy of Breastfeeding Medicine, the American College of Nurse-Midwives, the National Association of Nurse Practitioners in Women’s Health, the Society for Academic Specialists in General Obstetrics and Gynecology, and the Society for Maternal-Fetal Medicine. The committee opinion did not require external funding, and the authors did not report any disclosures.
SOURCE: Obstet Gynecol 2018;131:e140-50.
It’s time to introduce a new paradigm for comprehensive care of women’s physical and mental health in the 3 months after giving birth, according to the American College of Obstetricians and Gynecologists.
In their newly revised committee opinion on postpartum care, ACOG encouraged doctors to think of a woman’s immediate postpartum period as a “fourth trimester” during which better care for women may help reduce maternal deaths and morbidity. That care includes a 3-week postpartum visit and a more comprehensive one within 3 months post partum.
Despite common practices in many other cultures that provide intense, dedicated support to women during the 30-40 days after giving birth, U.S. women typically only see their ob.gyn. at a single 6-week postpartum visit and receive little to no other formal maternal support. Beyond that visit, U.S. postpartum care typically is fragmented and inconsistent, split sporadically among pediatric and maternal providers and with little support in the transition from inpatient to outpatient care, the committee wrote.
Further, 40% of women do not attend a postpartum visit at all, and more than half of maternal deaths occur after the baby’s birth. The committee aims to overhaul maternal care and potentially help reduce those numbers. That process begins with prenatal discussions about the mother’s transition to parenthood, caring for herself and her health, her reproductive life plans, her desires related to future children, the timing of future pregnancies, and appropriate contraceptive options and decisions.
“Underutilization of postpartum care impedes management of chronic health conditions and access to effective contraception, which increases the risk of short interval pregnancy and preterm birth,” the committee wrote. “Attendance rates are lower among populations with limited resources, which contributes to health disparities.”
Components of comprehensive postpartum care
ACOG recommends the prenatal preparation for the postpartum period include discussions about infant feeding, “baby blues,” postpartum emotional health, parenting challenges, postpartum recovery from birth, long-term management of chronic health conditions, choosing a primary care provider for the mother’s ongoing care, her reproductive desires and choices, and any concerns about interpersonal or partner violence.
Before giving birth, a woman should develop a postpartum care plan with her physician and assemble a care team that includes her primary care providers along with family and friends who can provide support. The plan should include contact information for questions and written instructions about postpartum visits and follow-up care.
Prenatal planning also provides an opportunity to discuss a woman’s breastfeeding plans, goals, and questions as well as common physical problems that women may experience in the weeks after giving birth, such as heavy bleeding, pain, physical exhaustion, and urinary incontinence.
Physicians should inform women of the risks and benefits of becoming pregnant within 18 months and advise them not to have pregnancy intervals of less than 6 months. They should also ensure women know all their contraceptive options and should provide any information necessary for women to determine which methods best meet her needs.
The committee recommended a postpartum visit within the first 3 weeks after birth, instead of the current “6-week check,” that is timed and tailored to each woman’s particular needs. This visit allows assessment of postpartum depression risk and/or treatment and discussion of breastfeeding goals and/or difficulties. Approximately one in five women who stopped breastfeeding earlier than they wanted to had ceased within first 6 weeks post partum.
Woman-centered follow-up should be tailored to women’s individual needs and include a comprehensive postpartum visit no later than 12 weeks after giving birth. The comprehensive visit should include a complete assessment of the woman’s physical, social, and psychological well-being, including discussion of “mood and emotional well-being, infant care and feeding, sexuality, contraception, birth spacing, sleep and fatigue, physical recovery from birth, chronic disease management, and health maintenance,” the committee wrote.
The comprehensive visit should include the following components:
- Postpartum depression and anxiety screening.
- Screening for tobacco use and substance use.
- Follow-up on preexisting mental and physical health conditions.
- Assessment of mother’s confidence and comfort with newborn care, including feeding method, childcare strategy, identification of the child’s medical home, and recommended immunizations for all caregivers.
- Comfort and confidence with breastfeeding and management of any challenges, such as breastfeeding-associated pain; logistics and legal rights after returning to work or school; and fertility and contraception with breastfeeding.
- Assessment of material needs, including housing, utilities, food, and diapers.
- Guidance on sexuality, dyspareunia, reproductive life plans, contraception, and management of recurrent pregnancy complications, such as daily low-dose aspirin to reduce preeclampsia risk and 17a-hydroxyprogesterone caproate to reduce recurrent preterm birth.
- Sleep, fatigue, and coping options.
- Physical recovery from birth, including assessment of urinary and fecal continence and guidance on physical activity and a healthy weight.
- Chronic disease management and long-term implications of those conditions.
- Health maintenance, including review of vaccination history, needed vaccinations, and well-woman screenings, including Pap test and pelvic examination as indicated.
“However timed, the comprehensive postpartum visit is a medical appointment; it is not an ‘all-clear’ signal,” the authors wrote. “Obstetrician-gynecologists and other obstetric care providers should ensure that women, their families, and their employers understand that completion of the comprehensive postpartum visit does not obviate the need for continued recovery and support through 6 weeks’ post partum and beyond.”
Women with comorbidities or adverse birth outcomes
Women who had gestational diabetes, gestational hypertension, preeclampsia, eclampsia, or a preterm birth should be informed of their increased lifetime risk of cardiovascular and metabolic disease, the committee recommended. Women who have experienced a miscarriage, stillbirth, or neonatal death should also follow up with their provider, who can offer resources for emotional support and bereavement counseling, referrals as needed, a review of any laboratory or pathology results related to the loss and counseling regarding future risks and pregnancies.
The committee recommended that women with chronic medical conditions follow up with their ob.gyn. or other primary care providers to ensure ongoing coordinated care for hypertension, obesity, diabetes, thyroid disorders, renal disease, mood disorders, substance use disorders, seizure disorders, and any other chronic issues. Care should include assessment of medications, including antiepileptics and psychotropic drugs, that may require adjustment for postpartum physiology and, if relevant, breastfeeding.
Since half of postpartum strokes occur within the first 10 days after discharge, ACOG recommends women with other hypertensive disorders of pregnancy have a postpartum visit within 7-10 days after birth to assess blood pressure. A follow-up visit should occur within 72 hours for those with severe hypertension.
ACOG also recommended early postpartum follow-up for women with increased risk of complications, including postpartum depression, cesarean or perennial wound infections, lactation difficulties, or chronic conditions.
The committee opinion concluded with a call for public policy changes, including endorsement of guaranteed 100% paid parental leave for a minimum of 6 weeks with full benefits. Currently, 23% of employed mothers return to work in the first 10 days after giving birth, and another 22% return within 10-30 days, the committee cited. Close to half of employed mothers therefore go back to work before the 6-week postpartum follow-up visit.
“Obstetrician-gynecologists and other obstetric care providers should be in the forefront of policy efforts to enable all women to recover from birth and nurture their infants,” the committee wrote.
The ACOG Presidential Task Force on Redefining the Postpartum Visit and the Committee on Obstetrics Practice developed the new clinical opinion, which is endorsed by the Academy of Breastfeeding Medicine, the American College of Nurse-Midwives, the National Association of Nurse Practitioners in Women’s Health, the Society for Academic Specialists in General Obstetrics and Gynecology, and the Society for Maternal-Fetal Medicine. The committee opinion did not require external funding, and the authors did not report any disclosures.
SOURCE: Obstet Gynecol 2018;131:e140-50.
FROM OBSTETRICS & GYNECOLOGY
Key clinical point: New recommendations on postpartum care advise earlier and more comprehensive follow-up visits and propose a new paradigm for ensuring the physical, emotional, and mental health of women in the first 12 weeks after giving birth.
Major finding: Women should have a follow-up visit within 3 weeks post partum – earlier if they have chronic conditions or had pregnancy complications – and an additional comprehensive visit no later than 12 weeks post partum.
Data source: The findings are based on an assessment of existing evidence on postpartum care, postpartum risks, and currently unfulfilled needs that ob.gyns. can and should fulfill, according to ACOG.
Disclosures: The committee opinion did not require external funding, and the authors did not report any disclosures.
Source: Obstet Gynecol 2018;131:e140-50.
No increased intussusception risk from rotavirus vaccine in Africa
Neither the first nor second dose of the monovalent rotavirus vaccine increased the risk of intussusception in the 3 weeks after immunization, a recent study found.
“This finding contrasts with previous studies in high- and upper-middle-income countries, in which an association with intussusception was found,” Jacqueline E. Tate, PhD, of the Centers for Disease Control and Prevention, and her associates reported in the New England Journal of Medicine.
“Given these large health benefits, the absence of increased risk of intussusception after RV1 [monovalent Rotarix vaccine] administration in our study is reassuring,” the authors wrote.
An African Intussusception Surveillance Network at 29 hospitals in Ethiopia, Ghana, Kenya, Malawi, Tanzania, Zambia and Zimbabwe enrolled 1,060 infants younger than age 12 months who experienced intussusception during Feb. 2012-Dec. 2016.
The researchers excluded infants without confirmed record of rotavirus vaccination status or who developed intussusception symptoms when younger than 28 days or older than 245 days. A little more than a third of the remaining 717 infants (36%) were from Ghana, more than half (61%) were male, and their median age was 25 weeks. Only 2% of the children had never received breast milk before developing intussusception symptoms.
The researchers used vaccine cards and clinic records to determine the rotavirus vaccination status for those 717 children with intussusception. The majority of the children (84%) had received both doses of the monovalent rotavirus vaccine. A total of 6% had received only one dose, and 10% received none. Five children received at least one rotavirus vaccine dose after having had intussusception already.
One intussusception case occurred within the first 7 days after the first vaccine dose, and five cases occurred within a week of the second dose. These incidences were no higher than was the background rate of intussusception, so no increased risk of intussusception in the week after either dose was identified, the researchers said.
The relative incidence of intussusception for dose one during days 1-7 was 0.25 (95% confidence interval, less than .001-1.16), and the relative incidence of intussusception for dose two during days 1-7 was 0.76 (95% CI, 0.16-1.87), Dr. Tate and her associates said.
Incidence of intussusception during the period 8-21 days after vaccination included 6 cases after the first dose and 16 cases after the second dose. Intussusception risk in this extended postvaccination period also was no higher than background risk.
“No clustering of cases occurred in any of the risk windows (1-7 days, 8-21 days, or 1-21 days) after receipt of either dose of RV1,” the authors reported.
They offered several possible reasons why no increased intussusception risk with rotavirus vaccination occurred in these countries despite studies in middle- and high-income countries showing an increased risk.
“First, although the exact mechanism is not known, intussusception may be related to intestinal replication of the orally administered, live-vaccine rotavirus strain,” Dr. Tate and her colleagues wrote. “Because oral rotavirus vaccines are less efficacious and shedding of vaccine virus – a potential marker of vaccine replication – is less frequently detected in low-income countries than in high- and middle-income countries, rotavirus vaccination might also be associated with a lower intussusception risk in low-income countries.”
Coadministration of rotavirus vaccination with the first dose of oral polio vaccine, which can reduce the rotavirus vaccine’s immunogenicity, also may play a role. Further, the children in this study were vaccinated against rotavirus at age 6- and 10-weeks-old – earlier than the 8 and 16 weeks in middle- and high-income countries – and intussusception is less common under 2 months old, potentially reducing likelihood of an association. Diet, breastfeeding practices, microbiome, maternal antibody levels, or other factors also may be at play.
The research was funded by the Gavi Alliance through the CDC Foundation. Dr. Cunliffe and Dr. Lopman have received personal fees from GlaxoSmithKline and Takeda Pharmaceutical, respectively. The other authors had no disclosures.
SOURCE: Tate JE et al. N Engl J Med. 2018;378:1521-8.
Neither the first nor second dose of the monovalent rotavirus vaccine increased the risk of intussusception in the 3 weeks after immunization, a recent study found.
“This finding contrasts with previous studies in high- and upper-middle-income countries, in which an association with intussusception was found,” Jacqueline E. Tate, PhD, of the Centers for Disease Control and Prevention, and her associates reported in the New England Journal of Medicine.
“Given these large health benefits, the absence of increased risk of intussusception after RV1 [monovalent Rotarix vaccine] administration in our study is reassuring,” the authors wrote.
An African Intussusception Surveillance Network at 29 hospitals in Ethiopia, Ghana, Kenya, Malawi, Tanzania, Zambia and Zimbabwe enrolled 1,060 infants younger than age 12 months who experienced intussusception during Feb. 2012-Dec. 2016.
The researchers excluded infants without confirmed record of rotavirus vaccination status or who developed intussusception symptoms when younger than 28 days or older than 245 days. A little more than a third of the remaining 717 infants (36%) were from Ghana, more than half (61%) were male, and their median age was 25 weeks. Only 2% of the children had never received breast milk before developing intussusception symptoms.
The researchers used vaccine cards and clinic records to determine the rotavirus vaccination status for those 717 children with intussusception. The majority of the children (84%) had received both doses of the monovalent rotavirus vaccine. A total of 6% had received only one dose, and 10% received none. Five children received at least one rotavirus vaccine dose after having had intussusception already.
One intussusception case occurred within the first 7 days after the first vaccine dose, and five cases occurred within a week of the second dose. These incidences were no higher than was the background rate of intussusception, so no increased risk of intussusception in the week after either dose was identified, the researchers said.
The relative incidence of intussusception for dose one during days 1-7 was 0.25 (95% confidence interval, less than .001-1.16), and the relative incidence of intussusception for dose two during days 1-7 was 0.76 (95% CI, 0.16-1.87), Dr. Tate and her associates said.
Incidence of intussusception during the period 8-21 days after vaccination included 6 cases after the first dose and 16 cases after the second dose. Intussusception risk in this extended postvaccination period also was no higher than background risk.
“No clustering of cases occurred in any of the risk windows (1-7 days, 8-21 days, or 1-21 days) after receipt of either dose of RV1,” the authors reported.
They offered several possible reasons why no increased intussusception risk with rotavirus vaccination occurred in these countries despite studies in middle- and high-income countries showing an increased risk.
“First, although the exact mechanism is not known, intussusception may be related to intestinal replication of the orally administered, live-vaccine rotavirus strain,” Dr. Tate and her colleagues wrote. “Because oral rotavirus vaccines are less efficacious and shedding of vaccine virus – a potential marker of vaccine replication – is less frequently detected in low-income countries than in high- and middle-income countries, rotavirus vaccination might also be associated with a lower intussusception risk in low-income countries.”
Coadministration of rotavirus vaccination with the first dose of oral polio vaccine, which can reduce the rotavirus vaccine’s immunogenicity, also may play a role. Further, the children in this study were vaccinated against rotavirus at age 6- and 10-weeks-old – earlier than the 8 and 16 weeks in middle- and high-income countries – and intussusception is less common under 2 months old, potentially reducing likelihood of an association. Diet, breastfeeding practices, microbiome, maternal antibody levels, or other factors also may be at play.
The research was funded by the Gavi Alliance through the CDC Foundation. Dr. Cunliffe and Dr. Lopman have received personal fees from GlaxoSmithKline and Takeda Pharmaceutical, respectively. The other authors had no disclosures.
SOURCE: Tate JE et al. N Engl J Med. 2018;378:1521-8.
Neither the first nor second dose of the monovalent rotavirus vaccine increased the risk of intussusception in the 3 weeks after immunization, a recent study found.
“This finding contrasts with previous studies in high- and upper-middle-income countries, in which an association with intussusception was found,” Jacqueline E. Tate, PhD, of the Centers for Disease Control and Prevention, and her associates reported in the New England Journal of Medicine.
“Given these large health benefits, the absence of increased risk of intussusception after RV1 [monovalent Rotarix vaccine] administration in our study is reassuring,” the authors wrote.
An African Intussusception Surveillance Network at 29 hospitals in Ethiopia, Ghana, Kenya, Malawi, Tanzania, Zambia and Zimbabwe enrolled 1,060 infants younger than age 12 months who experienced intussusception during Feb. 2012-Dec. 2016.
The researchers excluded infants without confirmed record of rotavirus vaccination status or who developed intussusception symptoms when younger than 28 days or older than 245 days. A little more than a third of the remaining 717 infants (36%) were from Ghana, more than half (61%) were male, and their median age was 25 weeks. Only 2% of the children had never received breast milk before developing intussusception symptoms.
The researchers used vaccine cards and clinic records to determine the rotavirus vaccination status for those 717 children with intussusception. The majority of the children (84%) had received both doses of the monovalent rotavirus vaccine. A total of 6% had received only one dose, and 10% received none. Five children received at least one rotavirus vaccine dose after having had intussusception already.
One intussusception case occurred within the first 7 days after the first vaccine dose, and five cases occurred within a week of the second dose. These incidences were no higher than was the background rate of intussusception, so no increased risk of intussusception in the week after either dose was identified, the researchers said.
The relative incidence of intussusception for dose one during days 1-7 was 0.25 (95% confidence interval, less than .001-1.16), and the relative incidence of intussusception for dose two during days 1-7 was 0.76 (95% CI, 0.16-1.87), Dr. Tate and her associates said.
Incidence of intussusception during the period 8-21 days after vaccination included 6 cases after the first dose and 16 cases after the second dose. Intussusception risk in this extended postvaccination period also was no higher than background risk.
“No clustering of cases occurred in any of the risk windows (1-7 days, 8-21 days, or 1-21 days) after receipt of either dose of RV1,” the authors reported.
They offered several possible reasons why no increased intussusception risk with rotavirus vaccination occurred in these countries despite studies in middle- and high-income countries showing an increased risk.
“First, although the exact mechanism is not known, intussusception may be related to intestinal replication of the orally administered, live-vaccine rotavirus strain,” Dr. Tate and her colleagues wrote. “Because oral rotavirus vaccines are less efficacious and shedding of vaccine virus – a potential marker of vaccine replication – is less frequently detected in low-income countries than in high- and middle-income countries, rotavirus vaccination might also be associated with a lower intussusception risk in low-income countries.”
Coadministration of rotavirus vaccination with the first dose of oral polio vaccine, which can reduce the rotavirus vaccine’s immunogenicity, also may play a role. Further, the children in this study were vaccinated against rotavirus at age 6- and 10-weeks-old – earlier than the 8 and 16 weeks in middle- and high-income countries – and intussusception is less common under 2 months old, potentially reducing likelihood of an association. Diet, breastfeeding practices, microbiome, maternal antibody levels, or other factors also may be at play.
The research was funded by the Gavi Alliance through the CDC Foundation. Dr. Cunliffe and Dr. Lopman have received personal fees from GlaxoSmithKline and Takeda Pharmaceutical, respectively. The other authors had no disclosures.
SOURCE: Tate JE et al. N Engl J Med. 2018;378:1521-8.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point:
Major finding: The relative incidence of intussusception for dose one during days 1-7 was 0.25 (95% confidence interval, less than .001-1.16), and the relative incidence of intussusception for dose two during days 1-7 was 0.76 (95% CI, 0.16-1.87).
Data source: The findings are based on a self-controlled case-series study involving 717 infants with intussusception and confirmed status of rotavirus vaccination, from Ethiopia, Ghana, Kenya, Malawi, Tanzania, Zambia, and Zimbabwe.
Disclosures: The research was funded by the Gavi Alliance through the CDC Foundation. Dr. Cunliffe and Dr. Lopman have received personal fees from GlaxoSmithKline and Takeda Pharmaceutical, respectively. The other authors had no disclosures.
Source: Tate JE et al. N Engl J Med. 2018;378:1521-8.