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Size of meals, not timing, linked to weight loss
The number of daily meals, but not the timing between first and last daily meals, was significantly associated with weight changes over a 6-year period, in a prospective study of more than 500 adults.
Some studies suggest that timing food intake – through time-restricted eating or intermittent fasting – can promote weight loss, but these strategies have yielded similar weight loss to eating throughout the day in randomized trials, and population-based studies of meal intervals and weight changes are needed, Di Zhao, PhD, of Johns Hopkins University, Baltimore, and colleagues wrote.
“Obesity is an epidemic,” corresponding author Wendy Bennett, MD, also of Johns Hopkins University, said in an interview. “We are interested in identifying ways to prevent weight gain over time and reduce obesity risk, since telling people to ‘just eat less’ doesn’t always work.”
In a study published in the Journal of the American Heart Association, the researchers recruited 1,017 adults who were patients at one of three health systems; of these, complete data were available for 547 individuals.
The participants downloaded an app called Daily24 to record the timing of their meals and sleep for at least 1 day. The researchers used electronic medical records to obtain information on weight and comorbidities of the participants for up to 10 years before study enrollment through 10 months after enrollment.
The mean age of the participants was 51.1 years, 78% were women, and 78% were White; the mean body mass index was 30.8 kg/m2.
The mean interval from first to last meal was 11.5 hours, and this was not associated with change in weight. The mean times from waking up to the first meal and the time from the last meal to sleeping were 1.6 hours and 4.0 hours, respectively, and these were not associated with weight changes over the follow-up period, the researchers wrote. Sleep duration (mean of 7.5 hours) also was not associated with weight change over time.
However, the total daily number of large and medium-sized meals was associated with weight gain over time, while those who reported more smaller meals showed weight loss. A daily increase of one large, medium, or small meal was associated with an average annual weight change of 0.69 kg, 0.97 kg, and –0.30 kg, respectively.
Benefits of time-restricted eating remain unclear
“Animal studies have shown benefits for time restricted feeding, but there are still questions about whether or not it helps prevent weight gain or promotes weight loss in humans,” Dr. Bennett said in an interview.
As for the current study findings, “we were not surprised; humans are more complicated than animals, and we have complicated behaviors, especially with eating,” she said.
“We showed that windows of eating (eating for longer periods of time or less in a day) was not associated with weight change over time among patients from three health systems,” said Dr. Bennett. “The main implication is that restricting your window of eating, such as eating over less time, or having more fasting time, may not reduce weight gain over time, while eating fewer large meals is associated with less weight gain over time.”
The findings were limited by several factors including the exclusion of many younger and less educated individuals, the short follow-up period, and lack of information on weight loss intention at baseline, the researchers noted. Other limitations included the inability to evaluate time-restricted eating or fasting, and the inclusion of individuals currently seeking care, which may limit generalizability.
However, the results were strengthened by the repeated measures of weight, detailed information on obesity risk factors, and real-time assessment of eating behaviors. The results do not support time-restricted eating as a long-term weight-loss strategy, and more studies are needed with a longer follow-up period, the researchers concluded.
However, there may be a role for time restricted eating as a method of total calorie control, Dr. Bennett said.
“Other studies do show that people might be able to use time-restricted eating or intermittent fasting to help them reduce their caloric intake and thus lose weight, so it can still be a helpful weight loss tool for some people who can adhere to it,” she said.
The study was supported by a grant from the American Heart Association to Johns Hopkins University. Dr. Bennett had no financial conflicts to disclose.
The number of daily meals, but not the timing between first and last daily meals, was significantly associated with weight changes over a 6-year period, in a prospective study of more than 500 adults.
Some studies suggest that timing food intake – through time-restricted eating or intermittent fasting – can promote weight loss, but these strategies have yielded similar weight loss to eating throughout the day in randomized trials, and population-based studies of meal intervals and weight changes are needed, Di Zhao, PhD, of Johns Hopkins University, Baltimore, and colleagues wrote.
“Obesity is an epidemic,” corresponding author Wendy Bennett, MD, also of Johns Hopkins University, said in an interview. “We are interested in identifying ways to prevent weight gain over time and reduce obesity risk, since telling people to ‘just eat less’ doesn’t always work.”
In a study published in the Journal of the American Heart Association, the researchers recruited 1,017 adults who were patients at one of three health systems; of these, complete data were available for 547 individuals.
The participants downloaded an app called Daily24 to record the timing of their meals and sleep for at least 1 day. The researchers used electronic medical records to obtain information on weight and comorbidities of the participants for up to 10 years before study enrollment through 10 months after enrollment.
The mean age of the participants was 51.1 years, 78% were women, and 78% were White; the mean body mass index was 30.8 kg/m2.
The mean interval from first to last meal was 11.5 hours, and this was not associated with change in weight. The mean times from waking up to the first meal and the time from the last meal to sleeping were 1.6 hours and 4.0 hours, respectively, and these were not associated with weight changes over the follow-up period, the researchers wrote. Sleep duration (mean of 7.5 hours) also was not associated with weight change over time.
However, the total daily number of large and medium-sized meals was associated with weight gain over time, while those who reported more smaller meals showed weight loss. A daily increase of one large, medium, or small meal was associated with an average annual weight change of 0.69 kg, 0.97 kg, and –0.30 kg, respectively.
Benefits of time-restricted eating remain unclear
“Animal studies have shown benefits for time restricted feeding, but there are still questions about whether or not it helps prevent weight gain or promotes weight loss in humans,” Dr. Bennett said in an interview.
As for the current study findings, “we were not surprised; humans are more complicated than animals, and we have complicated behaviors, especially with eating,” she said.
“We showed that windows of eating (eating for longer periods of time or less in a day) was not associated with weight change over time among patients from three health systems,” said Dr. Bennett. “The main implication is that restricting your window of eating, such as eating over less time, or having more fasting time, may not reduce weight gain over time, while eating fewer large meals is associated with less weight gain over time.”
The findings were limited by several factors including the exclusion of many younger and less educated individuals, the short follow-up period, and lack of information on weight loss intention at baseline, the researchers noted. Other limitations included the inability to evaluate time-restricted eating or fasting, and the inclusion of individuals currently seeking care, which may limit generalizability.
However, the results were strengthened by the repeated measures of weight, detailed information on obesity risk factors, and real-time assessment of eating behaviors. The results do not support time-restricted eating as a long-term weight-loss strategy, and more studies are needed with a longer follow-up period, the researchers concluded.
However, there may be a role for time restricted eating as a method of total calorie control, Dr. Bennett said.
“Other studies do show that people might be able to use time-restricted eating or intermittent fasting to help them reduce their caloric intake and thus lose weight, so it can still be a helpful weight loss tool for some people who can adhere to it,” she said.
The study was supported by a grant from the American Heart Association to Johns Hopkins University. Dr. Bennett had no financial conflicts to disclose.
The number of daily meals, but not the timing between first and last daily meals, was significantly associated with weight changes over a 6-year period, in a prospective study of more than 500 adults.
Some studies suggest that timing food intake – through time-restricted eating or intermittent fasting – can promote weight loss, but these strategies have yielded similar weight loss to eating throughout the day in randomized trials, and population-based studies of meal intervals and weight changes are needed, Di Zhao, PhD, of Johns Hopkins University, Baltimore, and colleagues wrote.
“Obesity is an epidemic,” corresponding author Wendy Bennett, MD, also of Johns Hopkins University, said in an interview. “We are interested in identifying ways to prevent weight gain over time and reduce obesity risk, since telling people to ‘just eat less’ doesn’t always work.”
In a study published in the Journal of the American Heart Association, the researchers recruited 1,017 adults who were patients at one of three health systems; of these, complete data were available for 547 individuals.
The participants downloaded an app called Daily24 to record the timing of their meals and sleep for at least 1 day. The researchers used electronic medical records to obtain information on weight and comorbidities of the participants for up to 10 years before study enrollment through 10 months after enrollment.
The mean age of the participants was 51.1 years, 78% were women, and 78% were White; the mean body mass index was 30.8 kg/m2.
The mean interval from first to last meal was 11.5 hours, and this was not associated with change in weight. The mean times from waking up to the first meal and the time from the last meal to sleeping were 1.6 hours and 4.0 hours, respectively, and these were not associated with weight changes over the follow-up period, the researchers wrote. Sleep duration (mean of 7.5 hours) also was not associated with weight change over time.
However, the total daily number of large and medium-sized meals was associated with weight gain over time, while those who reported more smaller meals showed weight loss. A daily increase of one large, medium, or small meal was associated with an average annual weight change of 0.69 kg, 0.97 kg, and –0.30 kg, respectively.
Benefits of time-restricted eating remain unclear
“Animal studies have shown benefits for time restricted feeding, but there are still questions about whether or not it helps prevent weight gain or promotes weight loss in humans,” Dr. Bennett said in an interview.
As for the current study findings, “we were not surprised; humans are more complicated than animals, and we have complicated behaviors, especially with eating,” she said.
“We showed that windows of eating (eating for longer periods of time or less in a day) was not associated with weight change over time among patients from three health systems,” said Dr. Bennett. “The main implication is that restricting your window of eating, such as eating over less time, or having more fasting time, may not reduce weight gain over time, while eating fewer large meals is associated with less weight gain over time.”
The findings were limited by several factors including the exclusion of many younger and less educated individuals, the short follow-up period, and lack of information on weight loss intention at baseline, the researchers noted. Other limitations included the inability to evaluate time-restricted eating or fasting, and the inclusion of individuals currently seeking care, which may limit generalizability.
However, the results were strengthened by the repeated measures of weight, detailed information on obesity risk factors, and real-time assessment of eating behaviors. The results do not support time-restricted eating as a long-term weight-loss strategy, and more studies are needed with a longer follow-up period, the researchers concluded.
However, there may be a role for time restricted eating as a method of total calorie control, Dr. Bennett said.
“Other studies do show that people might be able to use time-restricted eating or intermittent fasting to help them reduce their caloric intake and thus lose weight, so it can still be a helpful weight loss tool for some people who can adhere to it,” she said.
The study was supported by a grant from the American Heart Association to Johns Hopkins University. Dr. Bennett had no financial conflicts to disclose.
FROM THE JOURNAL OF THE AMERICAN HEART ASSOCIATION
Anxiety sensitivity fuels depression in dissociative identity disorder
Anxiety sensitivity refers to fear of the signs and symptoms of anxiety based on the individual’s belief that the signs of anxiety will have harmful consequences, wrote Xi Pan, LICSW, MPA, of McLean Hospital, Belmont, Mass., and colleagues.
Anxiety sensitivity can include cognitive, physical, and social elements: for example, fear that the inability to focus signals mental illness, fear that a racing heart might cause a heart attack, or fear that exhibiting anxiety signs in public (e.g., sweaty palms) will cause embarrassment, the researchers said.
Previous studies have found associations between anxiety sensitivity and panic attacks, and anxiety sensitivity has been shown to contribute to worsening symptoms in patients with anxiety disorders, depressive disorders, and trauma-related disorders such as posttraumatic stress disorder. However, “anxiety sensitivity has not been studied in individuals with complex dissociative disorders such as dissociative identity disorder (DID)” – who often have co-occurring PTSD and depression, the researchers said.
In a study published in the Journal of Psychiatric Research, the authors analyzed data from 21 treatment-seeking adult women with histories of childhood trauma, current PTSD, and dissociative identity disorder. Participants completed the Anxiety Sensitivity Index (ASI), Beck Depression Inventory-II, Childhood Trauma Questionnaire, Multidimensional Inventory of Dissociation, and PTSD Checklist for DSM-5.
Anxiety sensitivity in cognitive, physical, and social domains was assessed using ASI subscales.
Pearson correlations showed that symptoms of depression were significantly associated with anxiety sensitivity total scores and across all anxiety subscales. However, no direct associations appeared between anxiety sensitivity and PTSD or severe dissociative symptoms.
In a multiple regression analysis, the ASI cognitive subscale was a positive predictor of depressive symptoms, although physical and social subscale scores were not.
The researchers also tested for an indirect relationship between anxiety sensitivity and dissociative symptoms through depression. “Specifically, more severe ASI cognitive concerns were associated with more depressive symptoms, and more depressive symptoms predicted more severe pathological dissociation symptoms,” they wrote.
The findings were limited by the inability to show a direct causal relationship between anxiety sensitivity and depression, the researchers noted. Other limitations included the small sample size, use of self-reports, and the population of mainly White women, which may not generalize to other populations, they said.
However, the results represent the first empirical investigation of the relationship between anxiety sensitivity and DID symptoms, and support the value of assessment for anxiety sensitivity in DID patients in clinical practice, they said.
“If high levels of anxiety sensitivity are identified, the individual may benefit from targeted interventions, which in turn may alleviate some symptoms of depression and dissociation in DID,” the researchers concluded.
The study was supported by the National Institute of Mental Health and the Julia Kasparian Fund for Neuroscience Research. The researchers had no financial conflicts to disclose.
Anxiety sensitivity refers to fear of the signs and symptoms of anxiety based on the individual’s belief that the signs of anxiety will have harmful consequences, wrote Xi Pan, LICSW, MPA, of McLean Hospital, Belmont, Mass., and colleagues.
Anxiety sensitivity can include cognitive, physical, and social elements: for example, fear that the inability to focus signals mental illness, fear that a racing heart might cause a heart attack, or fear that exhibiting anxiety signs in public (e.g., sweaty palms) will cause embarrassment, the researchers said.
Previous studies have found associations between anxiety sensitivity and panic attacks, and anxiety sensitivity has been shown to contribute to worsening symptoms in patients with anxiety disorders, depressive disorders, and trauma-related disorders such as posttraumatic stress disorder. However, “anxiety sensitivity has not been studied in individuals with complex dissociative disorders such as dissociative identity disorder (DID)” – who often have co-occurring PTSD and depression, the researchers said.
In a study published in the Journal of Psychiatric Research, the authors analyzed data from 21 treatment-seeking adult women with histories of childhood trauma, current PTSD, and dissociative identity disorder. Participants completed the Anxiety Sensitivity Index (ASI), Beck Depression Inventory-II, Childhood Trauma Questionnaire, Multidimensional Inventory of Dissociation, and PTSD Checklist for DSM-5.
Anxiety sensitivity in cognitive, physical, and social domains was assessed using ASI subscales.
Pearson correlations showed that symptoms of depression were significantly associated with anxiety sensitivity total scores and across all anxiety subscales. However, no direct associations appeared between anxiety sensitivity and PTSD or severe dissociative symptoms.
In a multiple regression analysis, the ASI cognitive subscale was a positive predictor of depressive symptoms, although physical and social subscale scores were not.
The researchers also tested for an indirect relationship between anxiety sensitivity and dissociative symptoms through depression. “Specifically, more severe ASI cognitive concerns were associated with more depressive symptoms, and more depressive symptoms predicted more severe pathological dissociation symptoms,” they wrote.
The findings were limited by the inability to show a direct causal relationship between anxiety sensitivity and depression, the researchers noted. Other limitations included the small sample size, use of self-reports, and the population of mainly White women, which may not generalize to other populations, they said.
However, the results represent the first empirical investigation of the relationship between anxiety sensitivity and DID symptoms, and support the value of assessment for anxiety sensitivity in DID patients in clinical practice, they said.
“If high levels of anxiety sensitivity are identified, the individual may benefit from targeted interventions, which in turn may alleviate some symptoms of depression and dissociation in DID,” the researchers concluded.
The study was supported by the National Institute of Mental Health and the Julia Kasparian Fund for Neuroscience Research. The researchers had no financial conflicts to disclose.
Anxiety sensitivity refers to fear of the signs and symptoms of anxiety based on the individual’s belief that the signs of anxiety will have harmful consequences, wrote Xi Pan, LICSW, MPA, of McLean Hospital, Belmont, Mass., and colleagues.
Anxiety sensitivity can include cognitive, physical, and social elements: for example, fear that the inability to focus signals mental illness, fear that a racing heart might cause a heart attack, or fear that exhibiting anxiety signs in public (e.g., sweaty palms) will cause embarrassment, the researchers said.
Previous studies have found associations between anxiety sensitivity and panic attacks, and anxiety sensitivity has been shown to contribute to worsening symptoms in patients with anxiety disorders, depressive disorders, and trauma-related disorders such as posttraumatic stress disorder. However, “anxiety sensitivity has not been studied in individuals with complex dissociative disorders such as dissociative identity disorder (DID)” – who often have co-occurring PTSD and depression, the researchers said.
In a study published in the Journal of Psychiatric Research, the authors analyzed data from 21 treatment-seeking adult women with histories of childhood trauma, current PTSD, and dissociative identity disorder. Participants completed the Anxiety Sensitivity Index (ASI), Beck Depression Inventory-II, Childhood Trauma Questionnaire, Multidimensional Inventory of Dissociation, and PTSD Checklist for DSM-5.
Anxiety sensitivity in cognitive, physical, and social domains was assessed using ASI subscales.
Pearson correlations showed that symptoms of depression were significantly associated with anxiety sensitivity total scores and across all anxiety subscales. However, no direct associations appeared between anxiety sensitivity and PTSD or severe dissociative symptoms.
In a multiple regression analysis, the ASI cognitive subscale was a positive predictor of depressive symptoms, although physical and social subscale scores were not.
The researchers also tested for an indirect relationship between anxiety sensitivity and dissociative symptoms through depression. “Specifically, more severe ASI cognitive concerns were associated with more depressive symptoms, and more depressive symptoms predicted more severe pathological dissociation symptoms,” they wrote.
The findings were limited by the inability to show a direct causal relationship between anxiety sensitivity and depression, the researchers noted. Other limitations included the small sample size, use of self-reports, and the population of mainly White women, which may not generalize to other populations, they said.
However, the results represent the first empirical investigation of the relationship between anxiety sensitivity and DID symptoms, and support the value of assessment for anxiety sensitivity in DID patients in clinical practice, they said.
“If high levels of anxiety sensitivity are identified, the individual may benefit from targeted interventions, which in turn may alleviate some symptoms of depression and dissociation in DID,” the researchers concluded.
The study was supported by the National Institute of Mental Health and the Julia Kasparian Fund for Neuroscience Research. The researchers had no financial conflicts to disclose.
FROM THE JOURNAL OF PSYCHIATRIC RESEARCH
Emotional eating tied to risk of diastolic dysfunction
Eating in response to stress – known as emotional eating – was significantly associated with several markers of long-term cardiovascular damage, based on data from 1,109 individuals.
“We know diet plays a huge role in cardiovascular disease, but we have focused a lot of work on what you eat, not on what makes you eat” – the current study did exactly that, Martha Gulati, MD, who wasn’t involved in the study, said in an interview.
“Emotional eaters consume food to satisfy their brains rather than their stomachs,” study investigator Nicolas Girerd, MD, of the National Institute of Health and Medical Research (INSERM) and a cardiologist at the University Hospital of Nancy (France), wrote in a press release accompanying the study.
Diet plays a role in the development of cardiovascular disease (CVD), but the impact of eating behavior on long-term cardiovascular health remains unclear, wrote Dr. Girerd and colleagues. Previous research has yielded three common psychological dimensions for eating behavior: emotional eating, restrained eating, and external eating.
Both emotional eating and restrained eating have been linked to cardiovascular disease risk, the researchers noted. “Because of previous findings, we hypothesized that [emotional and/or restrained dimensions of eating behavior] are positively associated with cardiovascular damages, as well as with CV risk factors, such as metabolic syndrome,” they wrote.
In a study published in the European Journal of Preventive Cardiology, the researchers reviewed data from 916 adults and 193 adolescents who were participants in the STANISLAS (Suivi Temporaire Annuel Non-Invasif de la Santé des Lorrains Assurés Sociaux), a longitudinal familial cohort in France. Cardiovascular data were collected at four medical visits as part of a full clinical examination between 1993 and 2016, with one visit every 5-10 years. Roughly one-third (31.0%) of the adults were overweight, 7.9% were obese, and 2.7% were underweight. The median age of the adults at the second visit was 44.7 years; the median age of the adolescent group was 15.2 years.
The primary outcome of cardiovascular damage was measured at the fourth visit. Eating behavior was assessed during the second visit using the Dutch Eating Behaviour Questionnaire (DEBQ), and participants were identified as emotional eaters, restrained eaters, or external eaters.
Among the adults, emotional eating was associated with a 38% increased risk of diastolic dysfunction (odds ratio, 1.38; P = .02), over an average follow-up of 13 years, and this association was mediated by stress in 32% of cases. Emotional eating also was positively linked with a higher carotid-femoral pulse-wave velocity (cfPWV-beta), indicative of increased arterial stiffness. However, none of the three dimensions of eating behavior was associated with cardiovascular damage among the adolescents. In addition, none of the eating-behavior dimensions was tied to metabolic syndrome in the adult group (this association was not measured in the adolescents).
Energy intake had no apparent impact on any associations between eating behavior and CVD measures, Dr. Girerd said in the press release. “We might expect that emotional eaters would consume high-calorie foods, which would in turn lead to cardiovascular problems, but this was not the case. One explanation is that we measured average calorie intake and emotional eaters may binge when stressed and then eat less at other times,” and that the resulting “yo-yo” pattern might negatively affect the heart and blood vessels more than stable food intake, he said.
The study findings were limited by several factors, including the observational design that prevented conclusions of causality, the researchers noted. Other limitations included the use of a nonvalidated scale to measure stress, the lack of data on physical activity, and the use of a mainly healthy population in a limited geographic area, which may limit generalizability, they said.
More research is needed in other contexts and larger cohorts, but the results were strengthened by the large study population and the complete data on eating behaviors and detailed health information, they wrote. The results support previous studies and suggest that patients with emotional eating behavior could benefit from emotion regulation skills training, including cognitive, behavioral, psychological, and interpersonal therapies used in other areas, and from pharmacological treatments, the researchers concluded.
The current study offers a unique and important perspective on the relationship between diet and cardiovascular disease, Dr. Gulati, director of preventive cardiology at the Smidt Heart Institute at Cedars-Sinai Medical Center, Los Angeles, told this news organization.
“Examining eating behavior and its relationship with cardiovascular effects in healthy individuals in this prospective way is quite interesting,” said Dr. Gulati, who was not involved in the study.
The researchers examined healthy people at baseline, inquired about their eating habits, and found that emotional eaters “have evidence of cardiovascular changes when compared with the other groups of eaters, after controlling for other risk factors that are associated with cardiovascular disease when following them for 13 years,” said Dr. Gulati, who was recently named Anita Dann Friedman Endowed Chair in Women’s Cardiovascular Medicine and Research at Cedars-Sinai. “This same finding wasn’t seen in adolescents, but this is probably because they are younger, and the effects aren’t seen. That is reassuring, because it means that the more we address eating behaviors, the more likely we are to reduce their effects to the heart,” she noted.
“This study is important because usually, as cardiologists or anyone in medicine, how we assess diet is by assessment of what food people eat; we don’t usually ask about what triggers them to eat,” Dr. Gulati said. “Eating behaviors based on their triggers ultimately affect food choice and food quantity, and help us understand weight changes during a lifetime,” she said.
“I think we don’t have the data to know that an eating behavior would be able to affect cardiac function,” said Dr. Gulati, “but I think we all might hypothesize that emotional eating may be associated with abnormal diastolic function simply through eating high-density food and weight gain.”
The current study did not show a relationship between eating behavior and metabolic syndrome, in contrast with prior studies, Dr. Gulati noted. However, “the authors report that the association between eating behaviors and diastolic dysfunction was mediated through the stress level,” Dr. Gulati said. “It is important to note that this European population was healthy at baseline, and also relatively healthy 13 years later, which makes these findings even more profound.”
Dr. Gulati said that she agrees with the study authors on the need to assess diet and eating behaviors when assessing cardiovascular risk in patient. “Diet assessment as part of prevention is central, but we should ask not only ‘what do you eat,’ but also ‘what makes you eat,’ ” she said.
More research is needed in other populations, Dr. Gulati added. The current study population was healthy at baseline and follow-up. Studies are needed in cohorts in the United States and in the developing world to see how the results might differ; as well as in rural America or in “food deserts” where food choices are limited.
Another research topic is the interplay between eating behaviors and social determinants of health, in terms of their effect on cardiovascular function, Dr. Gulati said, “and it will be valuable to follow this cohort further to see how these eating behaviors and these intermediate measures translate into cardiovascular outcomes.” Future studies should also examine whether the changes in cardiac function are reversible by interventions to modify eating behavior, particularly emotional eating, she said.
Supporters of the study included the Regional University Hospital Center of Nancy, the French Ministry of Solidarity and Health, and a public grant overseen by the French National Research Agency. The researchers had no financial conflicts to disclose.
Dr. Gulati, who serves on the editorial advisory board of MDedge Cardiology, had no financial conflicts to disclose.
Eating in response to stress – known as emotional eating – was significantly associated with several markers of long-term cardiovascular damage, based on data from 1,109 individuals.
“We know diet plays a huge role in cardiovascular disease, but we have focused a lot of work on what you eat, not on what makes you eat” – the current study did exactly that, Martha Gulati, MD, who wasn’t involved in the study, said in an interview.
“Emotional eaters consume food to satisfy their brains rather than their stomachs,” study investigator Nicolas Girerd, MD, of the National Institute of Health and Medical Research (INSERM) and a cardiologist at the University Hospital of Nancy (France), wrote in a press release accompanying the study.
Diet plays a role in the development of cardiovascular disease (CVD), but the impact of eating behavior on long-term cardiovascular health remains unclear, wrote Dr. Girerd and colleagues. Previous research has yielded three common psychological dimensions for eating behavior: emotional eating, restrained eating, and external eating.
Both emotional eating and restrained eating have been linked to cardiovascular disease risk, the researchers noted. “Because of previous findings, we hypothesized that [emotional and/or restrained dimensions of eating behavior] are positively associated with cardiovascular damages, as well as with CV risk factors, such as metabolic syndrome,” they wrote.
In a study published in the European Journal of Preventive Cardiology, the researchers reviewed data from 916 adults and 193 adolescents who were participants in the STANISLAS (Suivi Temporaire Annuel Non-Invasif de la Santé des Lorrains Assurés Sociaux), a longitudinal familial cohort in France. Cardiovascular data were collected at four medical visits as part of a full clinical examination between 1993 and 2016, with one visit every 5-10 years. Roughly one-third (31.0%) of the adults were overweight, 7.9% were obese, and 2.7% were underweight. The median age of the adults at the second visit was 44.7 years; the median age of the adolescent group was 15.2 years.
The primary outcome of cardiovascular damage was measured at the fourth visit. Eating behavior was assessed during the second visit using the Dutch Eating Behaviour Questionnaire (DEBQ), and participants were identified as emotional eaters, restrained eaters, or external eaters.
Among the adults, emotional eating was associated with a 38% increased risk of diastolic dysfunction (odds ratio, 1.38; P = .02), over an average follow-up of 13 years, and this association was mediated by stress in 32% of cases. Emotional eating also was positively linked with a higher carotid-femoral pulse-wave velocity (cfPWV-beta), indicative of increased arterial stiffness. However, none of the three dimensions of eating behavior was associated with cardiovascular damage among the adolescents. In addition, none of the eating-behavior dimensions was tied to metabolic syndrome in the adult group (this association was not measured in the adolescents).
Energy intake had no apparent impact on any associations between eating behavior and CVD measures, Dr. Girerd said in the press release. “We might expect that emotional eaters would consume high-calorie foods, which would in turn lead to cardiovascular problems, but this was not the case. One explanation is that we measured average calorie intake and emotional eaters may binge when stressed and then eat less at other times,” and that the resulting “yo-yo” pattern might negatively affect the heart and blood vessels more than stable food intake, he said.
The study findings were limited by several factors, including the observational design that prevented conclusions of causality, the researchers noted. Other limitations included the use of a nonvalidated scale to measure stress, the lack of data on physical activity, and the use of a mainly healthy population in a limited geographic area, which may limit generalizability, they said.
More research is needed in other contexts and larger cohorts, but the results were strengthened by the large study population and the complete data on eating behaviors and detailed health information, they wrote. The results support previous studies and suggest that patients with emotional eating behavior could benefit from emotion regulation skills training, including cognitive, behavioral, psychological, and interpersonal therapies used in other areas, and from pharmacological treatments, the researchers concluded.
The current study offers a unique and important perspective on the relationship between diet and cardiovascular disease, Dr. Gulati, director of preventive cardiology at the Smidt Heart Institute at Cedars-Sinai Medical Center, Los Angeles, told this news organization.
“Examining eating behavior and its relationship with cardiovascular effects in healthy individuals in this prospective way is quite interesting,” said Dr. Gulati, who was not involved in the study.
The researchers examined healthy people at baseline, inquired about their eating habits, and found that emotional eaters “have evidence of cardiovascular changes when compared with the other groups of eaters, after controlling for other risk factors that are associated with cardiovascular disease when following them for 13 years,” said Dr. Gulati, who was recently named Anita Dann Friedman Endowed Chair in Women’s Cardiovascular Medicine and Research at Cedars-Sinai. “This same finding wasn’t seen in adolescents, but this is probably because they are younger, and the effects aren’t seen. That is reassuring, because it means that the more we address eating behaviors, the more likely we are to reduce their effects to the heart,” she noted.
“This study is important because usually, as cardiologists or anyone in medicine, how we assess diet is by assessment of what food people eat; we don’t usually ask about what triggers them to eat,” Dr. Gulati said. “Eating behaviors based on their triggers ultimately affect food choice and food quantity, and help us understand weight changes during a lifetime,” she said.
“I think we don’t have the data to know that an eating behavior would be able to affect cardiac function,” said Dr. Gulati, “but I think we all might hypothesize that emotional eating may be associated with abnormal diastolic function simply through eating high-density food and weight gain.”
The current study did not show a relationship between eating behavior and metabolic syndrome, in contrast with prior studies, Dr. Gulati noted. However, “the authors report that the association between eating behaviors and diastolic dysfunction was mediated through the stress level,” Dr. Gulati said. “It is important to note that this European population was healthy at baseline, and also relatively healthy 13 years later, which makes these findings even more profound.”
Dr. Gulati said that she agrees with the study authors on the need to assess diet and eating behaviors when assessing cardiovascular risk in patient. “Diet assessment as part of prevention is central, but we should ask not only ‘what do you eat,’ but also ‘what makes you eat,’ ” she said.
More research is needed in other populations, Dr. Gulati added. The current study population was healthy at baseline and follow-up. Studies are needed in cohorts in the United States and in the developing world to see how the results might differ; as well as in rural America or in “food deserts” where food choices are limited.
Another research topic is the interplay between eating behaviors and social determinants of health, in terms of their effect on cardiovascular function, Dr. Gulati said, “and it will be valuable to follow this cohort further to see how these eating behaviors and these intermediate measures translate into cardiovascular outcomes.” Future studies should also examine whether the changes in cardiac function are reversible by interventions to modify eating behavior, particularly emotional eating, she said.
Supporters of the study included the Regional University Hospital Center of Nancy, the French Ministry of Solidarity and Health, and a public grant overseen by the French National Research Agency. The researchers had no financial conflicts to disclose.
Dr. Gulati, who serves on the editorial advisory board of MDedge Cardiology, had no financial conflicts to disclose.
Eating in response to stress – known as emotional eating – was significantly associated with several markers of long-term cardiovascular damage, based on data from 1,109 individuals.
“We know diet plays a huge role in cardiovascular disease, but we have focused a lot of work on what you eat, not on what makes you eat” – the current study did exactly that, Martha Gulati, MD, who wasn’t involved in the study, said in an interview.
“Emotional eaters consume food to satisfy their brains rather than their stomachs,” study investigator Nicolas Girerd, MD, of the National Institute of Health and Medical Research (INSERM) and a cardiologist at the University Hospital of Nancy (France), wrote in a press release accompanying the study.
Diet plays a role in the development of cardiovascular disease (CVD), but the impact of eating behavior on long-term cardiovascular health remains unclear, wrote Dr. Girerd and colleagues. Previous research has yielded three common psychological dimensions for eating behavior: emotional eating, restrained eating, and external eating.
Both emotional eating and restrained eating have been linked to cardiovascular disease risk, the researchers noted. “Because of previous findings, we hypothesized that [emotional and/or restrained dimensions of eating behavior] are positively associated with cardiovascular damages, as well as with CV risk factors, such as metabolic syndrome,” they wrote.
In a study published in the European Journal of Preventive Cardiology, the researchers reviewed data from 916 adults and 193 adolescents who were participants in the STANISLAS (Suivi Temporaire Annuel Non-Invasif de la Santé des Lorrains Assurés Sociaux), a longitudinal familial cohort in France. Cardiovascular data were collected at four medical visits as part of a full clinical examination between 1993 and 2016, with one visit every 5-10 years. Roughly one-third (31.0%) of the adults were overweight, 7.9% were obese, and 2.7% were underweight. The median age of the adults at the second visit was 44.7 years; the median age of the adolescent group was 15.2 years.
The primary outcome of cardiovascular damage was measured at the fourth visit. Eating behavior was assessed during the second visit using the Dutch Eating Behaviour Questionnaire (DEBQ), and participants were identified as emotional eaters, restrained eaters, or external eaters.
Among the adults, emotional eating was associated with a 38% increased risk of diastolic dysfunction (odds ratio, 1.38; P = .02), over an average follow-up of 13 years, and this association was mediated by stress in 32% of cases. Emotional eating also was positively linked with a higher carotid-femoral pulse-wave velocity (cfPWV-beta), indicative of increased arterial stiffness. However, none of the three dimensions of eating behavior was associated with cardiovascular damage among the adolescents. In addition, none of the eating-behavior dimensions was tied to metabolic syndrome in the adult group (this association was not measured in the adolescents).
Energy intake had no apparent impact on any associations between eating behavior and CVD measures, Dr. Girerd said in the press release. “We might expect that emotional eaters would consume high-calorie foods, which would in turn lead to cardiovascular problems, but this was not the case. One explanation is that we measured average calorie intake and emotional eaters may binge when stressed and then eat less at other times,” and that the resulting “yo-yo” pattern might negatively affect the heart and blood vessels more than stable food intake, he said.
The study findings were limited by several factors, including the observational design that prevented conclusions of causality, the researchers noted. Other limitations included the use of a nonvalidated scale to measure stress, the lack of data on physical activity, and the use of a mainly healthy population in a limited geographic area, which may limit generalizability, they said.
More research is needed in other contexts and larger cohorts, but the results were strengthened by the large study population and the complete data on eating behaviors and detailed health information, they wrote. The results support previous studies and suggest that patients with emotional eating behavior could benefit from emotion regulation skills training, including cognitive, behavioral, psychological, and interpersonal therapies used in other areas, and from pharmacological treatments, the researchers concluded.
The current study offers a unique and important perspective on the relationship between diet and cardiovascular disease, Dr. Gulati, director of preventive cardiology at the Smidt Heart Institute at Cedars-Sinai Medical Center, Los Angeles, told this news organization.
“Examining eating behavior and its relationship with cardiovascular effects in healthy individuals in this prospective way is quite interesting,” said Dr. Gulati, who was not involved in the study.
The researchers examined healthy people at baseline, inquired about their eating habits, and found that emotional eaters “have evidence of cardiovascular changes when compared with the other groups of eaters, after controlling for other risk factors that are associated with cardiovascular disease when following them for 13 years,” said Dr. Gulati, who was recently named Anita Dann Friedman Endowed Chair in Women’s Cardiovascular Medicine and Research at Cedars-Sinai. “This same finding wasn’t seen in adolescents, but this is probably because they are younger, and the effects aren’t seen. That is reassuring, because it means that the more we address eating behaviors, the more likely we are to reduce their effects to the heart,” she noted.
“This study is important because usually, as cardiologists or anyone in medicine, how we assess diet is by assessment of what food people eat; we don’t usually ask about what triggers them to eat,” Dr. Gulati said. “Eating behaviors based on their triggers ultimately affect food choice and food quantity, and help us understand weight changes during a lifetime,” she said.
“I think we don’t have the data to know that an eating behavior would be able to affect cardiac function,” said Dr. Gulati, “but I think we all might hypothesize that emotional eating may be associated with abnormal diastolic function simply through eating high-density food and weight gain.”
The current study did not show a relationship between eating behavior and metabolic syndrome, in contrast with prior studies, Dr. Gulati noted. However, “the authors report that the association between eating behaviors and diastolic dysfunction was mediated through the stress level,” Dr. Gulati said. “It is important to note that this European population was healthy at baseline, and also relatively healthy 13 years later, which makes these findings even more profound.”
Dr. Gulati said that she agrees with the study authors on the need to assess diet and eating behaviors when assessing cardiovascular risk in patient. “Diet assessment as part of prevention is central, but we should ask not only ‘what do you eat,’ but also ‘what makes you eat,’ ” she said.
More research is needed in other populations, Dr. Gulati added. The current study population was healthy at baseline and follow-up. Studies are needed in cohorts in the United States and in the developing world to see how the results might differ; as well as in rural America or in “food deserts” where food choices are limited.
Another research topic is the interplay between eating behaviors and social determinants of health, in terms of their effect on cardiovascular function, Dr. Gulati said, “and it will be valuable to follow this cohort further to see how these eating behaviors and these intermediate measures translate into cardiovascular outcomes.” Future studies should also examine whether the changes in cardiac function are reversible by interventions to modify eating behavior, particularly emotional eating, she said.
Supporters of the study included the Regional University Hospital Center of Nancy, the French Ministry of Solidarity and Health, and a public grant overseen by the French National Research Agency. The researchers had no financial conflicts to disclose.
Dr. Gulati, who serves on the editorial advisory board of MDedge Cardiology, had no financial conflicts to disclose.
FROM THE EUROPEAN JOURNAL OF PREVENTIVE CARDIOLOGY
Adverse events reported in one-quarter of inpatient admissions
as indicated from data from 2,809 admissions at 11 hospitals.
The 1991 Harvard Medical Practice Study, which focused on medical injury and litigation, documented an adverse event rate of 3.7 events per 100 admissions; 28% of those events were attributed to negligence, write David W. Bates, MD, of Brigham and Women’s Hospital, Boston, and colleagues.
Although patient safety has changed significantly since 1991, documenting improvements has been challenging, the researchers say. Several reports have shown a decrease in health care–associated infections. However, other aspects of safety – notably, adverse drug events, defined as injuries resulting from drugs taken – are not easily measured and tracked, the researchers say.
“We have not had good estimates of how much harm is being caused by care in hospitals in an ongoing way that looked across all types of adverse events,” and the current review is therefore important, Dr. Bates said in an interview.
In a study recently published in the New England Journal of Medicine, the researchers analyzed a random sample of 2,809 hospital admissions from 11 hospitals in Massachusetts during the 2018 calendar year. The hospitals ranged in size from fewer than 100 beds to more than 700 beds; all patients were aged 18 years and older. A panel of nine nurses reviewed the admissions records to identify potential adverse events, and eight physicians reviewed the adverse event summaries and either agreed or disagreed with the adverse event type. The severity of each event was ranked using a general severity scale into categories of significant, serious, life-threatening, or fatal.
Overall, at least one adverse event was identified in 23.6% of the hospital admissions. A total of 978 adverse events were deemed to have occurred during the index admission, and 222 of these (22.7%) were deemed preventable. Among the preventable adverse events, 19.7% were classified as serious, 3.3% as life-threatening, and 0.5% as fatal.
A total of 523 admissions (18.6%) involved at least one significant adverse event, defined as an event that caused unnecessary harm but from which recovery was rapid. A total of 211 admissions involved a serious adverse event, defined as harm resulting in substantial intervention or prolonged recovery; 34 included at least one life-threatening event; and seven admissions involved a fatal adverse event.
A total of 191 admissions involved at least one adverse event deemed preventable. Of those, 29 involved at least one preventable adverse event that was serious, life-threatening, or fatal, the researchers write. Of the seven deaths in the study population, one was deemed preventable.
The most common adverse events were adverse drug events, which accounted for 39.0% of the adverse events; surgical or other procedural events accounted for 30.4%; patient care events (including falls and pressure ulcers) accounted for 15.0%; and health care–associated infections accounted for 11.9%.
Overcoming barriers to better safety
“The overall level of harm, with nearly 1 in 4 patients suffering an adverse event, was higher than I expected it might be,” Dr. Bates told this news organization. However, techniques for identifying adverse events have improved, and “it is easier to find them in electronic records than in paper records,” he noted.
“Hospitals have many issues they are currently dealing with since COVID, and one issue is simply prioritization,” Dr. Bates said. “But it is now possible to measure harm for all patients using electronic tools, and if hospitals know how much harm they are having in specific areas, they can make choices about which ones to focus on.”
“We now have effective prevention strategies for most of the main kinds of harm,” he said. Generally, rates of harm are high because these strategies are not being used effectively, he said. “In addition, there are new tools that can be used – for example, to identify patients who are decompensating earlier,” he noted.
As for additional research, some specific types of harm that have been resistant to interventions, such as pressure ulcers, deserve more attention, said Dr. Bates. “In addition, diagnostic errors appear to cause a great deal of harm, but we don’t yet have good strategies for preventing these,” he said.
The study findings were limited by several factors, including the use of data from hospitals that might not represent hospitals at large and by the inclusion mainly of patients with private insurance, the researchers write. Other limitations include the likelihood that some adverse events were missed and the level of agreement on adverse events between adjudicators was only fair.
However, the findings serve as a reminder to health care professionals of the need for continued attention to improving patient safety, and measuring adverse events remains a critical part of guiding these improvements, the researchers conclude.
Timely reassessment and opportunities to improve
In the decades since the publication of the report, “To Err Is Human,” by the National Academies in 2000, significant attention has been paid to improving patient safety during hospitalizations, and health care systems have increased in both system and disease complexity, Said Suman Pal, MBBS, a specialist in hospital medicine at the University of New Mexico, Albuquerque, said in an interview. “Therefore, this study is important in reassessing the safety of inpatient care at the current time,” he said.
“The findings of this study showing preventable adverse events in approximately 7% of all admissions; while concerning, is not surprising, as it is consistent with other studies over time, as the authors have also noted in their discussion,” said Dr. Pal. The current findings “underscore the importance of continuous quality improvement efforts to increase the safety of patient care for hospitalized patients,” he noted.
“The increasing complexity of medical care, fragmentation of health care, structural inequities of health systems, and more recent widespread public health challenges such as the COVID-19 pandemic have been, in my opinion, barriers to improving patient safety,” Dr. Pal said. “The use of innovation and an interdisciplinary approach to patient safety and quality improvement in hospital-based care, such as the use of machine learning to monitor trends and predict the individualized risk of harm, could be a potential way out” to help reduce barriers and improve safety, he said.
“Additional research is needed to understand the key drivers of preventable harm for hospitalized patients in the United States,” said Dr. Pal. “When planning for change, keen attention must be paid to understanding how these [drivers] may differ for patients who have been historically marginalized or are otherwise underserved so as to not exacerbate health care inequities,” he added.
The study was funded by the Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions. Dr. Bates owns stock options with AESOP, Clew, FeelBetter, Guided Clinical Solutions, MDClone, and ValeraHealth and has grants/contracts from IBM Watson and EarlySense. He has also served as a consultant for CDI Negev. Dr. Pal has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
as indicated from data from 2,809 admissions at 11 hospitals.
The 1991 Harvard Medical Practice Study, which focused on medical injury and litigation, documented an adverse event rate of 3.7 events per 100 admissions; 28% of those events were attributed to negligence, write David W. Bates, MD, of Brigham and Women’s Hospital, Boston, and colleagues.
Although patient safety has changed significantly since 1991, documenting improvements has been challenging, the researchers say. Several reports have shown a decrease in health care–associated infections. However, other aspects of safety – notably, adverse drug events, defined as injuries resulting from drugs taken – are not easily measured and tracked, the researchers say.
“We have not had good estimates of how much harm is being caused by care in hospitals in an ongoing way that looked across all types of adverse events,” and the current review is therefore important, Dr. Bates said in an interview.
In a study recently published in the New England Journal of Medicine, the researchers analyzed a random sample of 2,809 hospital admissions from 11 hospitals in Massachusetts during the 2018 calendar year. The hospitals ranged in size from fewer than 100 beds to more than 700 beds; all patients were aged 18 years and older. A panel of nine nurses reviewed the admissions records to identify potential adverse events, and eight physicians reviewed the adverse event summaries and either agreed or disagreed with the adverse event type. The severity of each event was ranked using a general severity scale into categories of significant, serious, life-threatening, or fatal.
Overall, at least one adverse event was identified in 23.6% of the hospital admissions. A total of 978 adverse events were deemed to have occurred during the index admission, and 222 of these (22.7%) were deemed preventable. Among the preventable adverse events, 19.7% were classified as serious, 3.3% as life-threatening, and 0.5% as fatal.
A total of 523 admissions (18.6%) involved at least one significant adverse event, defined as an event that caused unnecessary harm but from which recovery was rapid. A total of 211 admissions involved a serious adverse event, defined as harm resulting in substantial intervention or prolonged recovery; 34 included at least one life-threatening event; and seven admissions involved a fatal adverse event.
A total of 191 admissions involved at least one adverse event deemed preventable. Of those, 29 involved at least one preventable adverse event that was serious, life-threatening, or fatal, the researchers write. Of the seven deaths in the study population, one was deemed preventable.
The most common adverse events were adverse drug events, which accounted for 39.0% of the adverse events; surgical or other procedural events accounted for 30.4%; patient care events (including falls and pressure ulcers) accounted for 15.0%; and health care–associated infections accounted for 11.9%.
Overcoming barriers to better safety
“The overall level of harm, with nearly 1 in 4 patients suffering an adverse event, was higher than I expected it might be,” Dr. Bates told this news organization. However, techniques for identifying adverse events have improved, and “it is easier to find them in electronic records than in paper records,” he noted.
“Hospitals have many issues they are currently dealing with since COVID, and one issue is simply prioritization,” Dr. Bates said. “But it is now possible to measure harm for all patients using electronic tools, and if hospitals know how much harm they are having in specific areas, they can make choices about which ones to focus on.”
“We now have effective prevention strategies for most of the main kinds of harm,” he said. Generally, rates of harm are high because these strategies are not being used effectively, he said. “In addition, there are new tools that can be used – for example, to identify patients who are decompensating earlier,” he noted.
As for additional research, some specific types of harm that have been resistant to interventions, such as pressure ulcers, deserve more attention, said Dr. Bates. “In addition, diagnostic errors appear to cause a great deal of harm, but we don’t yet have good strategies for preventing these,” he said.
The study findings were limited by several factors, including the use of data from hospitals that might not represent hospitals at large and by the inclusion mainly of patients with private insurance, the researchers write. Other limitations include the likelihood that some adverse events were missed and the level of agreement on adverse events between adjudicators was only fair.
However, the findings serve as a reminder to health care professionals of the need for continued attention to improving patient safety, and measuring adverse events remains a critical part of guiding these improvements, the researchers conclude.
Timely reassessment and opportunities to improve
In the decades since the publication of the report, “To Err Is Human,” by the National Academies in 2000, significant attention has been paid to improving patient safety during hospitalizations, and health care systems have increased in both system and disease complexity, Said Suman Pal, MBBS, a specialist in hospital medicine at the University of New Mexico, Albuquerque, said in an interview. “Therefore, this study is important in reassessing the safety of inpatient care at the current time,” he said.
“The findings of this study showing preventable adverse events in approximately 7% of all admissions; while concerning, is not surprising, as it is consistent with other studies over time, as the authors have also noted in their discussion,” said Dr. Pal. The current findings “underscore the importance of continuous quality improvement efforts to increase the safety of patient care for hospitalized patients,” he noted.
“The increasing complexity of medical care, fragmentation of health care, structural inequities of health systems, and more recent widespread public health challenges such as the COVID-19 pandemic have been, in my opinion, barriers to improving patient safety,” Dr. Pal said. “The use of innovation and an interdisciplinary approach to patient safety and quality improvement in hospital-based care, such as the use of machine learning to monitor trends and predict the individualized risk of harm, could be a potential way out” to help reduce barriers and improve safety, he said.
“Additional research is needed to understand the key drivers of preventable harm for hospitalized patients in the United States,” said Dr. Pal. “When planning for change, keen attention must be paid to understanding how these [drivers] may differ for patients who have been historically marginalized or are otherwise underserved so as to not exacerbate health care inequities,” he added.
The study was funded by the Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions. Dr. Bates owns stock options with AESOP, Clew, FeelBetter, Guided Clinical Solutions, MDClone, and ValeraHealth and has grants/contracts from IBM Watson and EarlySense. He has also served as a consultant for CDI Negev. Dr. Pal has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
as indicated from data from 2,809 admissions at 11 hospitals.
The 1991 Harvard Medical Practice Study, which focused on medical injury and litigation, documented an adverse event rate of 3.7 events per 100 admissions; 28% of those events were attributed to negligence, write David W. Bates, MD, of Brigham and Women’s Hospital, Boston, and colleagues.
Although patient safety has changed significantly since 1991, documenting improvements has been challenging, the researchers say. Several reports have shown a decrease in health care–associated infections. However, other aspects of safety – notably, adverse drug events, defined as injuries resulting from drugs taken – are not easily measured and tracked, the researchers say.
“We have not had good estimates of how much harm is being caused by care in hospitals in an ongoing way that looked across all types of adverse events,” and the current review is therefore important, Dr. Bates said in an interview.
In a study recently published in the New England Journal of Medicine, the researchers analyzed a random sample of 2,809 hospital admissions from 11 hospitals in Massachusetts during the 2018 calendar year. The hospitals ranged in size from fewer than 100 beds to more than 700 beds; all patients were aged 18 years and older. A panel of nine nurses reviewed the admissions records to identify potential adverse events, and eight physicians reviewed the adverse event summaries and either agreed or disagreed with the adverse event type. The severity of each event was ranked using a general severity scale into categories of significant, serious, life-threatening, or fatal.
Overall, at least one adverse event was identified in 23.6% of the hospital admissions. A total of 978 adverse events were deemed to have occurred during the index admission, and 222 of these (22.7%) were deemed preventable. Among the preventable adverse events, 19.7% were classified as serious, 3.3% as life-threatening, and 0.5% as fatal.
A total of 523 admissions (18.6%) involved at least one significant adverse event, defined as an event that caused unnecessary harm but from which recovery was rapid. A total of 211 admissions involved a serious adverse event, defined as harm resulting in substantial intervention or prolonged recovery; 34 included at least one life-threatening event; and seven admissions involved a fatal adverse event.
A total of 191 admissions involved at least one adverse event deemed preventable. Of those, 29 involved at least one preventable adverse event that was serious, life-threatening, or fatal, the researchers write. Of the seven deaths in the study population, one was deemed preventable.
The most common adverse events were adverse drug events, which accounted for 39.0% of the adverse events; surgical or other procedural events accounted for 30.4%; patient care events (including falls and pressure ulcers) accounted for 15.0%; and health care–associated infections accounted for 11.9%.
Overcoming barriers to better safety
“The overall level of harm, with nearly 1 in 4 patients suffering an adverse event, was higher than I expected it might be,” Dr. Bates told this news organization. However, techniques for identifying adverse events have improved, and “it is easier to find them in electronic records than in paper records,” he noted.
“Hospitals have many issues they are currently dealing with since COVID, and one issue is simply prioritization,” Dr. Bates said. “But it is now possible to measure harm for all patients using electronic tools, and if hospitals know how much harm they are having in specific areas, they can make choices about which ones to focus on.”
“We now have effective prevention strategies for most of the main kinds of harm,” he said. Generally, rates of harm are high because these strategies are not being used effectively, he said. “In addition, there are new tools that can be used – for example, to identify patients who are decompensating earlier,” he noted.
As for additional research, some specific types of harm that have been resistant to interventions, such as pressure ulcers, deserve more attention, said Dr. Bates. “In addition, diagnostic errors appear to cause a great deal of harm, but we don’t yet have good strategies for preventing these,” he said.
The study findings were limited by several factors, including the use of data from hospitals that might not represent hospitals at large and by the inclusion mainly of patients with private insurance, the researchers write. Other limitations include the likelihood that some adverse events were missed and the level of agreement on adverse events between adjudicators was only fair.
However, the findings serve as a reminder to health care professionals of the need for continued attention to improving patient safety, and measuring adverse events remains a critical part of guiding these improvements, the researchers conclude.
Timely reassessment and opportunities to improve
In the decades since the publication of the report, “To Err Is Human,” by the National Academies in 2000, significant attention has been paid to improving patient safety during hospitalizations, and health care systems have increased in both system and disease complexity, Said Suman Pal, MBBS, a specialist in hospital medicine at the University of New Mexico, Albuquerque, said in an interview. “Therefore, this study is important in reassessing the safety of inpatient care at the current time,” he said.
“The findings of this study showing preventable adverse events in approximately 7% of all admissions; while concerning, is not surprising, as it is consistent with other studies over time, as the authors have also noted in their discussion,” said Dr. Pal. The current findings “underscore the importance of continuous quality improvement efforts to increase the safety of patient care for hospitalized patients,” he noted.
“The increasing complexity of medical care, fragmentation of health care, structural inequities of health systems, and more recent widespread public health challenges such as the COVID-19 pandemic have been, in my opinion, barriers to improving patient safety,” Dr. Pal said. “The use of innovation and an interdisciplinary approach to patient safety and quality improvement in hospital-based care, such as the use of machine learning to monitor trends and predict the individualized risk of harm, could be a potential way out” to help reduce barriers and improve safety, he said.
“Additional research is needed to understand the key drivers of preventable harm for hospitalized patients in the United States,” said Dr. Pal. “When planning for change, keen attention must be paid to understanding how these [drivers] may differ for patients who have been historically marginalized or are otherwise underserved so as to not exacerbate health care inequities,” he added.
The study was funded by the Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions. Dr. Bates owns stock options with AESOP, Clew, FeelBetter, Guided Clinical Solutions, MDClone, and ValeraHealth and has grants/contracts from IBM Watson and EarlySense. He has also served as a consultant for CDI Negev. Dr. Pal has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Components of coffee other than caffeine linked to reduced NAFLD severity
Increased intake of both regular and decaffeinated coffee was significantly associated with a reduced severity of NAFLD in the study, published in Nutrients. The study participants included 156 overweight adults, most of whom had type 2 diabetes.
A confluence of factors including diet and lifestyle changes and increased obesity have contributed to a rise in type 2 diabetes and of NAFLD, Margarida Coelho, of the Center for Neuroscience and Cell Biology at the University of Coimbra (Portugal), and colleagues wrote.
Previous studies support an association between coffee and protection against NAFLD, but the roles of the caffeine and noncaffeine components of coffee have not been examined, corresponding author John Griffith Jones, PhD, also of the Center for Neuroscience and Cell Biology at the University of Coimbra, said in an interview.
“There have been previous studies indicating a link between coffee intake and NAFLD amelioration, but these were entirely based on self-reporting questionnaire data, but the main limitation of this approach is that it does not provide any information on which components of coffee confer the beneficial effects,” Dr. Jones said. “The development of new analytical techniques allowing reliable profiling of coffee metabolites in urine allowed this limitation to be addressed.”
Dr. Jones and associates examined the relationship between consumption of regular and decaffeinated coffee on the fatty liver index (FLI), a validated predictor of NAFLD. They measured coffee intake of 156 overweight adults, 135 of whom had type 2 diabetes. The study population included 76 women and 80 men with a mean age of 59 years and a mean body mass index of 29 kg/m2.
The participants reported coffee intake via questionnaires, and 98 participants (all with type 2 diabetes) also provided urine samples for measurement of caffeine and noncaffeine metabolites (the products of the body breaking down coffee). NAFLD was assessed using the FLI and a scanning measure of fibrosis.
Overall, no associations appeared between self-reported coffee intake and NAFLD measures. However, urine caffeine metabolite levels were significantly higher among individuals with no liver fibrosis, compared with those with fibrosis, and noncaffeine metabolites showed a significant negative association with FLI measures.
In a multiple regression analysis of 89 individuals with type 2 diabetes, both caffeine and noncaffeine metabolites were negatively associated with FLI, which suggests less severe NAFLD, the researchers noted.
Although the mechanism of action remains unclear, the findings suggest that other noncaffeine coffee components such as polyphenols may reduce the risk of fibrosis by reducing oxidative stress on the liver, they said.
Benefits beyond caffeine
“The main surprise of the study was that both caffeine and noncaffeine metabolites had beneficial effects,” Dr. Jones said. “We had anticipated caffeine, based on its well-known effects on inhibiting liver fibrosis, but the effects of other components were less well described.”
Clinicians can encourage their patients with type 2 diabetes who drink coffee to continue to do so within a normal range (up to three to four cups per day) including decaffeinated coffee; however, “they should be strongly encouraged to drink coffee without added fats and sugars, otherwise the protective benefits [against more severe NAFLD] will not be realized,” Dr. Jones said.
Additional research is needed to extend the analysis to include more coffee compounds, especially those truly unique to coffee, since caffeine can be found in many other foods and beverages, Dr. Jones added.
Limitations include 24-hour time frame
The findings were limited by several factors, including the use of 24-hour urine sample, which may not represent an individual’s habitual coffee consumption, the researchers noted. The urine metabolites measured also may be derived from foods and beverages other than coffee. In addition, the assessment of NAFLD was based on serum markers and ultrasound/elastography, which are less precise than liver biopsy and magnetic resonance spectroscopy.
However, the study is the first known to use urine data to examine coffee’s protective effect against NAFLD and suggests that both caffeine and noncaffeine metabolites are associated with less severe disease, they concluded.
Findings intriguing but not ready for prime time
“The bottom line is that we have a major epidemic of NAFLD in the United States,” Victor L. Roberts, MD, professor of internal medicine at the University of Central Florida, Orlando, said in an interview. NAFLD has become the most common cause of chronic liver disease worldwide, and will become one of the leading causes of cirrhosis – surpassing infections as the main driver of end-stage liver disease.
“In this country, the epidemic of obesity compounds the problem, and risks for NAFLD include obesity and type 2 diabetes,” said Dr. Roberts.
The concept of coffee as beneficial is not new, but data suggest that the effects vary with insulin resistance, he said. If liver disease is advanced, coffee and its components may not have much benefit, but early on, it might have a role.
The likely mechanism of action for the benefits of coffee on the reduction in liver fibrosis is through a complex set of metabolic steps that interrupt the promotion of collagen production and reduce liver stiffness, said Dr. Roberts.
The current study authors were up front about the limitations, mainly the use of self-reports, although including the urine collection provided more scientific data, he said. More studies are needed in other populations, but the findings are interesting enough to merit additional research.
The take-home message for primary care, however, is that drinking coffee – regular or decaf – does not replace standard of care, Dr. Roberts emphasized.
“If a patient is a coffee drinker and they have NAFLD or are at risk, they could be encouraged to continue drinking coffee,” in reasonable amounts, said Dr. Roberts. “Anywhere from 1-3 cups a day is unlikely to be a problem, and there is some hope and interest in this area,” but the findings of the current study “should not be taken as gospel or advocacy as a solution for people with NAFLD.”
Instead, clinicians should focus on the standard of care for management of patients at risk for NAFLD, promoting lifestyle changes such as weight loss, diet, and exercise (challenging as that may be), and prescribing appropriate medications, he said.
The study was supported by the Institute for Scientific Information on Coffee, and the researchers received funding from the ISIC to conduct the study. Dr. Roberts had no financial conflicts to disclose, but he serves on the editorial advisory board of Internal Medicine News.
Increased intake of both regular and decaffeinated coffee was significantly associated with a reduced severity of NAFLD in the study, published in Nutrients. The study participants included 156 overweight adults, most of whom had type 2 diabetes.
A confluence of factors including diet and lifestyle changes and increased obesity have contributed to a rise in type 2 diabetes and of NAFLD, Margarida Coelho, of the Center for Neuroscience and Cell Biology at the University of Coimbra (Portugal), and colleagues wrote.
Previous studies support an association between coffee and protection against NAFLD, but the roles of the caffeine and noncaffeine components of coffee have not been examined, corresponding author John Griffith Jones, PhD, also of the Center for Neuroscience and Cell Biology at the University of Coimbra, said in an interview.
“There have been previous studies indicating a link between coffee intake and NAFLD amelioration, but these were entirely based on self-reporting questionnaire data, but the main limitation of this approach is that it does not provide any information on which components of coffee confer the beneficial effects,” Dr. Jones said. “The development of new analytical techniques allowing reliable profiling of coffee metabolites in urine allowed this limitation to be addressed.”
Dr. Jones and associates examined the relationship between consumption of regular and decaffeinated coffee on the fatty liver index (FLI), a validated predictor of NAFLD. They measured coffee intake of 156 overweight adults, 135 of whom had type 2 diabetes. The study population included 76 women and 80 men with a mean age of 59 years and a mean body mass index of 29 kg/m2.
The participants reported coffee intake via questionnaires, and 98 participants (all with type 2 diabetes) also provided urine samples for measurement of caffeine and noncaffeine metabolites (the products of the body breaking down coffee). NAFLD was assessed using the FLI and a scanning measure of fibrosis.
Overall, no associations appeared between self-reported coffee intake and NAFLD measures. However, urine caffeine metabolite levels were significantly higher among individuals with no liver fibrosis, compared with those with fibrosis, and noncaffeine metabolites showed a significant negative association with FLI measures.
In a multiple regression analysis of 89 individuals with type 2 diabetes, both caffeine and noncaffeine metabolites were negatively associated with FLI, which suggests less severe NAFLD, the researchers noted.
Although the mechanism of action remains unclear, the findings suggest that other noncaffeine coffee components such as polyphenols may reduce the risk of fibrosis by reducing oxidative stress on the liver, they said.
Benefits beyond caffeine
“The main surprise of the study was that both caffeine and noncaffeine metabolites had beneficial effects,” Dr. Jones said. “We had anticipated caffeine, based on its well-known effects on inhibiting liver fibrosis, but the effects of other components were less well described.”
Clinicians can encourage their patients with type 2 diabetes who drink coffee to continue to do so within a normal range (up to three to four cups per day) including decaffeinated coffee; however, “they should be strongly encouraged to drink coffee without added fats and sugars, otherwise the protective benefits [against more severe NAFLD] will not be realized,” Dr. Jones said.
Additional research is needed to extend the analysis to include more coffee compounds, especially those truly unique to coffee, since caffeine can be found in many other foods and beverages, Dr. Jones added.
Limitations include 24-hour time frame
The findings were limited by several factors, including the use of 24-hour urine sample, which may not represent an individual’s habitual coffee consumption, the researchers noted. The urine metabolites measured also may be derived from foods and beverages other than coffee. In addition, the assessment of NAFLD was based on serum markers and ultrasound/elastography, which are less precise than liver biopsy and magnetic resonance spectroscopy.
However, the study is the first known to use urine data to examine coffee’s protective effect against NAFLD and suggests that both caffeine and noncaffeine metabolites are associated with less severe disease, they concluded.
Findings intriguing but not ready for prime time
“The bottom line is that we have a major epidemic of NAFLD in the United States,” Victor L. Roberts, MD, professor of internal medicine at the University of Central Florida, Orlando, said in an interview. NAFLD has become the most common cause of chronic liver disease worldwide, and will become one of the leading causes of cirrhosis – surpassing infections as the main driver of end-stage liver disease.
“In this country, the epidemic of obesity compounds the problem, and risks for NAFLD include obesity and type 2 diabetes,” said Dr. Roberts.
The concept of coffee as beneficial is not new, but data suggest that the effects vary with insulin resistance, he said. If liver disease is advanced, coffee and its components may not have much benefit, but early on, it might have a role.
The likely mechanism of action for the benefits of coffee on the reduction in liver fibrosis is through a complex set of metabolic steps that interrupt the promotion of collagen production and reduce liver stiffness, said Dr. Roberts.
The current study authors were up front about the limitations, mainly the use of self-reports, although including the urine collection provided more scientific data, he said. More studies are needed in other populations, but the findings are interesting enough to merit additional research.
The take-home message for primary care, however, is that drinking coffee – regular or decaf – does not replace standard of care, Dr. Roberts emphasized.
“If a patient is a coffee drinker and they have NAFLD or are at risk, they could be encouraged to continue drinking coffee,” in reasonable amounts, said Dr. Roberts. “Anywhere from 1-3 cups a day is unlikely to be a problem, and there is some hope and interest in this area,” but the findings of the current study “should not be taken as gospel or advocacy as a solution for people with NAFLD.”
Instead, clinicians should focus on the standard of care for management of patients at risk for NAFLD, promoting lifestyle changes such as weight loss, diet, and exercise (challenging as that may be), and prescribing appropriate medications, he said.
The study was supported by the Institute for Scientific Information on Coffee, and the researchers received funding from the ISIC to conduct the study. Dr. Roberts had no financial conflicts to disclose, but he serves on the editorial advisory board of Internal Medicine News.
Increased intake of both regular and decaffeinated coffee was significantly associated with a reduced severity of NAFLD in the study, published in Nutrients. The study participants included 156 overweight adults, most of whom had type 2 diabetes.
A confluence of factors including diet and lifestyle changes and increased obesity have contributed to a rise in type 2 diabetes and of NAFLD, Margarida Coelho, of the Center for Neuroscience and Cell Biology at the University of Coimbra (Portugal), and colleagues wrote.
Previous studies support an association between coffee and protection against NAFLD, but the roles of the caffeine and noncaffeine components of coffee have not been examined, corresponding author John Griffith Jones, PhD, also of the Center for Neuroscience and Cell Biology at the University of Coimbra, said in an interview.
“There have been previous studies indicating a link between coffee intake and NAFLD amelioration, but these were entirely based on self-reporting questionnaire data, but the main limitation of this approach is that it does not provide any information on which components of coffee confer the beneficial effects,” Dr. Jones said. “The development of new analytical techniques allowing reliable profiling of coffee metabolites in urine allowed this limitation to be addressed.”
Dr. Jones and associates examined the relationship between consumption of regular and decaffeinated coffee on the fatty liver index (FLI), a validated predictor of NAFLD. They measured coffee intake of 156 overweight adults, 135 of whom had type 2 diabetes. The study population included 76 women and 80 men with a mean age of 59 years and a mean body mass index of 29 kg/m2.
The participants reported coffee intake via questionnaires, and 98 participants (all with type 2 diabetes) also provided urine samples for measurement of caffeine and noncaffeine metabolites (the products of the body breaking down coffee). NAFLD was assessed using the FLI and a scanning measure of fibrosis.
Overall, no associations appeared between self-reported coffee intake and NAFLD measures. However, urine caffeine metabolite levels were significantly higher among individuals with no liver fibrosis, compared with those with fibrosis, and noncaffeine metabolites showed a significant negative association with FLI measures.
In a multiple regression analysis of 89 individuals with type 2 diabetes, both caffeine and noncaffeine metabolites were negatively associated with FLI, which suggests less severe NAFLD, the researchers noted.
Although the mechanism of action remains unclear, the findings suggest that other noncaffeine coffee components such as polyphenols may reduce the risk of fibrosis by reducing oxidative stress on the liver, they said.
Benefits beyond caffeine
“The main surprise of the study was that both caffeine and noncaffeine metabolites had beneficial effects,” Dr. Jones said. “We had anticipated caffeine, based on its well-known effects on inhibiting liver fibrosis, but the effects of other components were less well described.”
Clinicians can encourage their patients with type 2 diabetes who drink coffee to continue to do so within a normal range (up to three to four cups per day) including decaffeinated coffee; however, “they should be strongly encouraged to drink coffee without added fats and sugars, otherwise the protective benefits [against more severe NAFLD] will not be realized,” Dr. Jones said.
Additional research is needed to extend the analysis to include more coffee compounds, especially those truly unique to coffee, since caffeine can be found in many other foods and beverages, Dr. Jones added.
Limitations include 24-hour time frame
The findings were limited by several factors, including the use of 24-hour urine sample, which may not represent an individual’s habitual coffee consumption, the researchers noted. The urine metabolites measured also may be derived from foods and beverages other than coffee. In addition, the assessment of NAFLD was based on serum markers and ultrasound/elastography, which are less precise than liver biopsy and magnetic resonance spectroscopy.
However, the study is the first known to use urine data to examine coffee’s protective effect against NAFLD and suggests that both caffeine and noncaffeine metabolites are associated with less severe disease, they concluded.
Findings intriguing but not ready for prime time
“The bottom line is that we have a major epidemic of NAFLD in the United States,” Victor L. Roberts, MD, professor of internal medicine at the University of Central Florida, Orlando, said in an interview. NAFLD has become the most common cause of chronic liver disease worldwide, and will become one of the leading causes of cirrhosis – surpassing infections as the main driver of end-stage liver disease.
“In this country, the epidemic of obesity compounds the problem, and risks for NAFLD include obesity and type 2 diabetes,” said Dr. Roberts.
The concept of coffee as beneficial is not new, but data suggest that the effects vary with insulin resistance, he said. If liver disease is advanced, coffee and its components may not have much benefit, but early on, it might have a role.
The likely mechanism of action for the benefits of coffee on the reduction in liver fibrosis is through a complex set of metabolic steps that interrupt the promotion of collagen production and reduce liver stiffness, said Dr. Roberts.
The current study authors were up front about the limitations, mainly the use of self-reports, although including the urine collection provided more scientific data, he said. More studies are needed in other populations, but the findings are interesting enough to merit additional research.
The take-home message for primary care, however, is that drinking coffee – regular or decaf – does not replace standard of care, Dr. Roberts emphasized.
“If a patient is a coffee drinker and they have NAFLD or are at risk, they could be encouraged to continue drinking coffee,” in reasonable amounts, said Dr. Roberts. “Anywhere from 1-3 cups a day is unlikely to be a problem, and there is some hope and interest in this area,” but the findings of the current study “should not be taken as gospel or advocacy as a solution for people with NAFLD.”
Instead, clinicians should focus on the standard of care for management of patients at risk for NAFLD, promoting lifestyle changes such as weight loss, diet, and exercise (challenging as that may be), and prescribing appropriate medications, he said.
The study was supported by the Institute for Scientific Information on Coffee, and the researchers received funding from the ISIC to conduct the study. Dr. Roberts had no financial conflicts to disclose, but he serves on the editorial advisory board of Internal Medicine News.
FROM NUTRIENTS
Borderline patients have longer time to depression remission
Major depressive episodes (MDEs) occur in major depressive disorder (MDD) and bipolar disorder (BD), John J. Söderholm, MD, of the University of Helsinki and colleagues wrote. Borderline personality disorder (BPD) includes an increased risk for depression, but data on the relationship between BPD symptoms and depressive illness are limited. In particular, they noted “a lack of studies prospectively comparing the presence of (hypo)manic symptoms over time during the recovery process from MDE between MDD, MDE/BD, and MDE/BPD patients.”
In a cohort study published in the Journal of Affective Disorders, the researchers collected data from 39 adult MDE patients with MDD, 33 with BD, and 23 with BPD. The patients were diagnosed with MDE using the SCID-I/P and SCID-II interviews, mixed symptoms were identified using the Mix-MDE scale, and borderline symptoms were identified using the Borderline Personality Disorder Severity Index.
Over a 6-month follow-up period, the participants completed biweekly online assessments. The primary outcomes were time to first full remission of symptoms and duration and nature of mood episodes.
Overall, the mean number of distinct mood states was 5.75, and the median duration was 60.9 days. When identified by subcohorts, the median number of mood state periods for MDD, BD, and BPD was 4.49, 8.05, and 4.67, respectively. The median durations were 69.2 days, 40.30 days, and 75.6 days, respectively.
The rates of remission for depressive symptoms were similar for MDD, MDE/BD, and MDE/BPD patients. However, MDE/BD patients had a significantly shorter time to first remission (hazard ratio, 2.44). Patients in the BPD group had a significantly longer time to first remission (HR, 0.95).
“When the cohort was divided into quintiles according to BPD feature severity, there was an approximately 1-month difference in time to first period of remission between the first and third and between the third and fifth quintiles, with longer times seen in patients with more severe BPD symptoms,” the researchers wrote.
The study findings were limited by several factors including the small sample size and short follow-up period that prevented investigation of depressive recurrence, the researchers noted. Other limitations included the lack of diagnostic blinding and variation in patients’ treatment schedules.
However, the results were strengthened by the representative samples of subjects with various disorders, the prospective and multimodal assessment of affective states, and the comparison of three patient groups in a single study.
As BPD was associated with a longer time to remission from depressive symptoms, the results suggest that BPD severity may be an indicator of more severe disease in patients with MDD in the context of depression, the researchers concluded.
The study was supported by the Finska Lakaresallskapet, the City of Helsinki, the Hospital District of Helsinki and Uusimaa, and the Finnish Psychiatric Association. The researchers had no financial conflicts to disclose.
Major depressive episodes (MDEs) occur in major depressive disorder (MDD) and bipolar disorder (BD), John J. Söderholm, MD, of the University of Helsinki and colleagues wrote. Borderline personality disorder (BPD) includes an increased risk for depression, but data on the relationship between BPD symptoms and depressive illness are limited. In particular, they noted “a lack of studies prospectively comparing the presence of (hypo)manic symptoms over time during the recovery process from MDE between MDD, MDE/BD, and MDE/BPD patients.”
In a cohort study published in the Journal of Affective Disorders, the researchers collected data from 39 adult MDE patients with MDD, 33 with BD, and 23 with BPD. The patients were diagnosed with MDE using the SCID-I/P and SCID-II interviews, mixed symptoms were identified using the Mix-MDE scale, and borderline symptoms were identified using the Borderline Personality Disorder Severity Index.
Over a 6-month follow-up period, the participants completed biweekly online assessments. The primary outcomes were time to first full remission of symptoms and duration and nature of mood episodes.
Overall, the mean number of distinct mood states was 5.75, and the median duration was 60.9 days. When identified by subcohorts, the median number of mood state periods for MDD, BD, and BPD was 4.49, 8.05, and 4.67, respectively. The median durations were 69.2 days, 40.30 days, and 75.6 days, respectively.
The rates of remission for depressive symptoms were similar for MDD, MDE/BD, and MDE/BPD patients. However, MDE/BD patients had a significantly shorter time to first remission (hazard ratio, 2.44). Patients in the BPD group had a significantly longer time to first remission (HR, 0.95).
“When the cohort was divided into quintiles according to BPD feature severity, there was an approximately 1-month difference in time to first period of remission between the first and third and between the third and fifth quintiles, with longer times seen in patients with more severe BPD symptoms,” the researchers wrote.
The study findings were limited by several factors including the small sample size and short follow-up period that prevented investigation of depressive recurrence, the researchers noted. Other limitations included the lack of diagnostic blinding and variation in patients’ treatment schedules.
However, the results were strengthened by the representative samples of subjects with various disorders, the prospective and multimodal assessment of affective states, and the comparison of three patient groups in a single study.
As BPD was associated with a longer time to remission from depressive symptoms, the results suggest that BPD severity may be an indicator of more severe disease in patients with MDD in the context of depression, the researchers concluded.
The study was supported by the Finska Lakaresallskapet, the City of Helsinki, the Hospital District of Helsinki and Uusimaa, and the Finnish Psychiatric Association. The researchers had no financial conflicts to disclose.
Major depressive episodes (MDEs) occur in major depressive disorder (MDD) and bipolar disorder (BD), John J. Söderholm, MD, of the University of Helsinki and colleagues wrote. Borderline personality disorder (BPD) includes an increased risk for depression, but data on the relationship between BPD symptoms and depressive illness are limited. In particular, they noted “a lack of studies prospectively comparing the presence of (hypo)manic symptoms over time during the recovery process from MDE between MDD, MDE/BD, and MDE/BPD patients.”
In a cohort study published in the Journal of Affective Disorders, the researchers collected data from 39 adult MDE patients with MDD, 33 with BD, and 23 with BPD. The patients were diagnosed with MDE using the SCID-I/P and SCID-II interviews, mixed symptoms were identified using the Mix-MDE scale, and borderline symptoms were identified using the Borderline Personality Disorder Severity Index.
Over a 6-month follow-up period, the participants completed biweekly online assessments. The primary outcomes were time to first full remission of symptoms and duration and nature of mood episodes.
Overall, the mean number of distinct mood states was 5.75, and the median duration was 60.9 days. When identified by subcohorts, the median number of mood state periods for MDD, BD, and BPD was 4.49, 8.05, and 4.67, respectively. The median durations were 69.2 days, 40.30 days, and 75.6 days, respectively.
The rates of remission for depressive symptoms were similar for MDD, MDE/BD, and MDE/BPD patients. However, MDE/BD patients had a significantly shorter time to first remission (hazard ratio, 2.44). Patients in the BPD group had a significantly longer time to first remission (HR, 0.95).
“When the cohort was divided into quintiles according to BPD feature severity, there was an approximately 1-month difference in time to first period of remission between the first and third and between the third and fifth quintiles, with longer times seen in patients with more severe BPD symptoms,” the researchers wrote.
The study findings were limited by several factors including the small sample size and short follow-up period that prevented investigation of depressive recurrence, the researchers noted. Other limitations included the lack of diagnostic blinding and variation in patients’ treatment schedules.
However, the results were strengthened by the representative samples of subjects with various disorders, the prospective and multimodal assessment of affective states, and the comparison of three patient groups in a single study.
As BPD was associated with a longer time to remission from depressive symptoms, the results suggest that BPD severity may be an indicator of more severe disease in patients with MDD in the context of depression, the researchers concluded.
The study was supported by the Finska Lakaresallskapet, the City of Helsinki, the Hospital District of Helsinki and Uusimaa, and the Finnish Psychiatric Association. The researchers had no financial conflicts to disclose.
FROM THE JOURNAL OF AFFECTIVE DISORDERS
Low serum LDH shows potential as depression biomarker
The pathogenesis of depression is complex, and recent research has focused on the potential relationship between energy metabolism and depression, wrote Qian Yao, MD, of Wuhan University, Hubei, China, and colleagues.
Previous studies have suggested that serum lactate dehydrogenase (LDH) may be a biomarker for Parkinson’s disease, Huntington’s disease, and post-stroke depression, but the link between lactate metabolism and depression remains unclear, they said.
“We hypothesize that LDH may act as a potential biomarker for MDD, considering it represents a reduced energy metabolic status in depressive patients,” they explained.
In a study published in General Hospital Psychiatry, the researchers examined differences in serum LDH in 232 patients with major depressive disorder (MDD) and 110 healthy controls. They also examined whether LDH was predictive of suicide attempts in the MDD patients. Depression was assessed via the 24-item Hamilton Depression Scale (HAMD-24).
The mean age across both groups was 33 years; other clinical characteristics were similar between the groups.
The serum LDH level of the MDD group was significantly lower than the control group was (177.94 U/L vs. 196.50 U/L; P < .001). Analysis of blood lipid levels showed significantly lower levels of total cholesterol in the MDD group compared with controls, but no significant differences were noted in LDL cholesterol, HDL cholesterol, or triglycerides.
In a further analysis of subgroups of depression, the serum LDH in MDD patients who had attempted suicide was significantly lower compared to those without suicide attempts (169.96 vs. 181.25; P = .002), although the LDH level for the non-suicide MDD patients also was significantly lower than controls (181.25 vs. 196.50; P < .001). No significant correlation was noted between HAMD-24 score and suicide attempts.
Some gender differences also appeared. Both male and female MDD patients had significantly lower LDH levels compared with controls. However, in a regression analysis, a correlation between total cholesterol and LDL cholesterol as potential suicide markers was noted in female MDD patients, but not male MDD patients, which suggests an impact of gender on suicide risk in MDD, the researchers wrote in their discussion.
The findings were limited by several factors including the retrospective design, lack of investigation of changes in LDH isozymes in MDD patients, and lack of assessment of changes in LDH in cerebrospinal fluid, the researchers noted. However, the results “provide clear evidence that the concentration of LDH in serum is associated with early onset and clinical prognosis of depressive symptoms,” in MDD, which may inform diagnosis and guide clinical intervention, including early identification of suicide risk, they concluded.
The study was supported by the National Natural Science Foundation of China. The researchers had no financial conflicts to disclose.
The pathogenesis of depression is complex, and recent research has focused on the potential relationship between energy metabolism and depression, wrote Qian Yao, MD, of Wuhan University, Hubei, China, and colleagues.
Previous studies have suggested that serum lactate dehydrogenase (LDH) may be a biomarker for Parkinson’s disease, Huntington’s disease, and post-stroke depression, but the link between lactate metabolism and depression remains unclear, they said.
“We hypothesize that LDH may act as a potential biomarker for MDD, considering it represents a reduced energy metabolic status in depressive patients,” they explained.
In a study published in General Hospital Psychiatry, the researchers examined differences in serum LDH in 232 patients with major depressive disorder (MDD) and 110 healthy controls. They also examined whether LDH was predictive of suicide attempts in the MDD patients. Depression was assessed via the 24-item Hamilton Depression Scale (HAMD-24).
The mean age across both groups was 33 years; other clinical characteristics were similar between the groups.
The serum LDH level of the MDD group was significantly lower than the control group was (177.94 U/L vs. 196.50 U/L; P < .001). Analysis of blood lipid levels showed significantly lower levels of total cholesterol in the MDD group compared with controls, but no significant differences were noted in LDL cholesterol, HDL cholesterol, or triglycerides.
In a further analysis of subgroups of depression, the serum LDH in MDD patients who had attempted suicide was significantly lower compared to those without suicide attempts (169.96 vs. 181.25; P = .002), although the LDH level for the non-suicide MDD patients also was significantly lower than controls (181.25 vs. 196.50; P < .001). No significant correlation was noted between HAMD-24 score and suicide attempts.
Some gender differences also appeared. Both male and female MDD patients had significantly lower LDH levels compared with controls. However, in a regression analysis, a correlation between total cholesterol and LDL cholesterol as potential suicide markers was noted in female MDD patients, but not male MDD patients, which suggests an impact of gender on suicide risk in MDD, the researchers wrote in their discussion.
The findings were limited by several factors including the retrospective design, lack of investigation of changes in LDH isozymes in MDD patients, and lack of assessment of changes in LDH in cerebrospinal fluid, the researchers noted. However, the results “provide clear evidence that the concentration of LDH in serum is associated with early onset and clinical prognosis of depressive symptoms,” in MDD, which may inform diagnosis and guide clinical intervention, including early identification of suicide risk, they concluded.
The study was supported by the National Natural Science Foundation of China. The researchers had no financial conflicts to disclose.
The pathogenesis of depression is complex, and recent research has focused on the potential relationship between energy metabolism and depression, wrote Qian Yao, MD, of Wuhan University, Hubei, China, and colleagues.
Previous studies have suggested that serum lactate dehydrogenase (LDH) may be a biomarker for Parkinson’s disease, Huntington’s disease, and post-stroke depression, but the link between lactate metabolism and depression remains unclear, they said.
“We hypothesize that LDH may act as a potential biomarker for MDD, considering it represents a reduced energy metabolic status in depressive patients,” they explained.
In a study published in General Hospital Psychiatry, the researchers examined differences in serum LDH in 232 patients with major depressive disorder (MDD) and 110 healthy controls. They also examined whether LDH was predictive of suicide attempts in the MDD patients. Depression was assessed via the 24-item Hamilton Depression Scale (HAMD-24).
The mean age across both groups was 33 years; other clinical characteristics were similar between the groups.
The serum LDH level of the MDD group was significantly lower than the control group was (177.94 U/L vs. 196.50 U/L; P < .001). Analysis of blood lipid levels showed significantly lower levels of total cholesterol in the MDD group compared with controls, but no significant differences were noted in LDL cholesterol, HDL cholesterol, or triglycerides.
In a further analysis of subgroups of depression, the serum LDH in MDD patients who had attempted suicide was significantly lower compared to those without suicide attempts (169.96 vs. 181.25; P = .002), although the LDH level for the non-suicide MDD patients also was significantly lower than controls (181.25 vs. 196.50; P < .001). No significant correlation was noted between HAMD-24 score and suicide attempts.
Some gender differences also appeared. Both male and female MDD patients had significantly lower LDH levels compared with controls. However, in a regression analysis, a correlation between total cholesterol and LDL cholesterol as potential suicide markers was noted in female MDD patients, but not male MDD patients, which suggests an impact of gender on suicide risk in MDD, the researchers wrote in their discussion.
The findings were limited by several factors including the retrospective design, lack of investigation of changes in LDH isozymes in MDD patients, and lack of assessment of changes in LDH in cerebrospinal fluid, the researchers noted. However, the results “provide clear evidence that the concentration of LDH in serum is associated with early onset and clinical prognosis of depressive symptoms,” in MDD, which may inform diagnosis and guide clinical intervention, including early identification of suicide risk, they concluded.
The study was supported by the National Natural Science Foundation of China. The researchers had no financial conflicts to disclose.
FROM GENERAL HOSPITAL PSYCHIATRY
Telehealth parent-child interaction therapy improved behavior in children with developmental delay
The children received the therapy with their parents or caregivers, who were more likely to demonstrate positive parenting behaviors than parents in the control group, authors of the new research published in JAMA Pediatrics found.
Approximately 13% of children have some form of developmental delay (DD) and more than half of these children also have at least one mental health disorder, which makes behavior problems a common and ongoing challenge, Daniel M. Bagner, PhD, a psychologist at Florida International University, Miami, and colleagues wrote.
Clinic-based interventions such as parent-child interaction therapy (PCIT) have been effective for improving behavior in children with DD, the researchers said. PCIT involves in-session caregiver coaching using a 1-way mirror and a wireless earpiece worn by the caregiver.
Barriers to the use of PCIT, especially in marginalized and low-income communities, include transportation, clinician shortages, and stigma-related concerns about a clinic visit, the researchers wrote. Technology now allows for Internet-delivered PCIT to reach more children and families, but its effectiveness for children with DD has not been well studied.
In the new study, the researchers randomized 150 children with DD and externalizing behavior problems to up to 20 weeks of Internet-delivered parent-child interaction therapy (iPCIT) or to referral as usual (RAU, the control group). The children were randomized after completion of early intervention services within 3 months of their third birthday, and participated in the sessions with a parent or caregiver. Most of the participants were from economically disadvantaged households and underrepresented ethnic backgrounds.
The iPCIT intervention was conducted weekly with a remote therapist and lasted for 1-1.5 hours; approximately half of the families received the intervention in Spanish.
The primary outcome was rating on the Child Behavior Checklist (CBCL) and assessment of children and caregivers using the Dyadic Parent-Child Interaction Coding System, fourth edition (DPICS). Assessments occurred at baseline and at week 20 (post treatment), with follow ups at 6 and 12 months.
Scores on the CBCL in the iPCIT group decreased from a mean of 61.18 at baseline to 53.83 post intervention. Scores for the control group started at 64.05 and decreased to 59.49 post intervention. At 6-12 months, the scores for both groups remained stable.
Children who received iPCIT with their parent or caregiver also showed significantly lower levels of externalizing behavior problems, compared with the RAU controls post treatment, and at 6-month and 12-month follow-ups based on the Cohen d measure of standardized effect size for differences between groups.
Significantly more children in the iPCIT group showed clinically significant improvements in externalizing problems at post treatment, compared with the RAU group (74% vs. 42%; P < .001) and at 6 months’ follow-up (73% vs. 45%; P = .002). However, the differences from baseline were not significantly different between the two groups after 12 months, which suggests that the effects may wane over time, the researchers noted.
In addition, the rate of child compliance with parent commands, as measured by a cleanup task, approximately doubled by the 12-month follow-up among children in the iPCIT group versus an increase of approximately one-third in the RAU group.
For secondary outcome measures related to caregiver behaviors, the proportion of observed positive parenting behaviors increased in the iPCIT group during the course of the intervention (postintervention odds ratio, 1.10), and the proportion of controlling and critical behaviors decreased (postintervention OR, 1.40). Harsh and inconsistent discipline decreased in both groups based on self-reports, but the decrease was steeper in iPCIT families.
iPCIT did not have a greater impact than RAU in reducing caregiver stress. The researchers wrote that they were not surprised by the lack of stress reduction “given mixed findings on the impact of parenting interventions on stress in caregivers of children with DD.”
Data support iPCIT potential
Overall, the results support findings from previous studies of clinic-based PCIT for children with DD and previous studies of telehealth interventions for typically developing children, the researchers said.
“Moreover, iPCIT-treated children not only showed reductions in behavior problems, such as aggression, but demonstrated higher rates of following directions, which is especially important for children entering kindergarten,” they wrote.
The findings were limited by several factors including the narrow focus on the primary and secondary outcomes, the use of data from a single site in a single metropolitan area – which may limit generalizability – and the lack of comparison between iPCIT and a clinic-based PCIT control group, the researchers noted. The equipment in the current study was provided to families; therefore, differences in treatment response could not be attributed to differences in technology.
The study represents the first known randomized controlled trial to evaluate a telehealth parenting intervention for children with, according to the researchers. The results suggest that technology can be leveraged to help these patients, including those from ethnic minority families who may be underserved by clinic-based care in overcoming barriers to treatment such as transportation and availability of clinicians. Use of iPCIT could be a critical resource as young children with DD complete Part C services and enter the school system.
Practical pediatric takeaways
“This was a great study, well-designed and very important and helpful for pediatric providers,” Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.
“Young children with developmental delay and/or mental and behavioral health disorders require early identification and intervention,” said Dr. Haut. However, obstacles to intervention include stigma or parental denial of the disorder, as well as more practical challenges related to transportation, time to access a clinic or office, potential long length of treatment, and cost.
“Despite availability of state programs for young children, follow up and continued services can be challenging to complete. Once the child outgrows the state program finding alternative therapy can be difficult with the current shortage of pediatric mental health providers,” Dr. Haut noted.
“I was surprised to see that this study treatment phase was completed prior to the COVID-19 pandemic, when telehealth was not as popular a mode for health care and was not utilized to the extent that it is now, especially for pediatric care,” said Dr. Haut. “I was not surprised at the results, as the traditional mode of PCIT includes therapy and training in a space that may not be as familiar to the child as their home environment, and would include live presence of the therapist/s, which may add to anxiety for both the parent and child.”
That almost half of the parents participating in the study had graduated from college and/or completed graduate degrees “may have contributed to some of the success of this study,” Dr. Haut noted.
Benefits and barriers
“The COVID-19 pandemic brought significant change to the frequency of use and overall success of telehealth services,” Dr. Haut said. “Additional provider education in aspects such as provider technique and the use of medical devices with improved specific health care technology assisted in advancing the experience and opportunity for successful telehealth visits. Telehealth therapy offers a cost-effective option for any pediatric patients and for providers, as the time and space commitment for the patient visit can be considerably less than live office visits.
“Unfortunately, there are still overall barriers that I have personally experienced with telehealth, including interruptions in connectivity, background noise, and lack of an available computer or tablet; and with the use of cell phones not always allowing full inclusion of the caregiver and child,” said Dr. Haut. Children with DD, behavioral problems, or other mental health disorders may pose challenges for parents to manage at home while simultaneously trying to fully focus on the therapy in an online setting.
Although the current study is encouraging, “larger studies focused on specific or individual pediatric mental health and/or behavioral disorders may offer more information for providers, and better document the success of telehealth delivery of services,” Dr. Haut said.
The study was supported by the National Institute of Child Health and Human Development. Dr. Bagner disclosed funding from the National Institutes of Health. He also disclosed personal fees from PCIT International to train clinicians in PCIT supported by a grant from the Florida Department of Children and Families outside the current study. Dr. Haut had no financial conflicts to disclose, but serves on the editorial advisory board of Pediatric News.
The children received the therapy with their parents or caregivers, who were more likely to demonstrate positive parenting behaviors than parents in the control group, authors of the new research published in JAMA Pediatrics found.
Approximately 13% of children have some form of developmental delay (DD) and more than half of these children also have at least one mental health disorder, which makes behavior problems a common and ongoing challenge, Daniel M. Bagner, PhD, a psychologist at Florida International University, Miami, and colleagues wrote.
Clinic-based interventions such as parent-child interaction therapy (PCIT) have been effective for improving behavior in children with DD, the researchers said. PCIT involves in-session caregiver coaching using a 1-way mirror and a wireless earpiece worn by the caregiver.
Barriers to the use of PCIT, especially in marginalized and low-income communities, include transportation, clinician shortages, and stigma-related concerns about a clinic visit, the researchers wrote. Technology now allows for Internet-delivered PCIT to reach more children and families, but its effectiveness for children with DD has not been well studied.
In the new study, the researchers randomized 150 children with DD and externalizing behavior problems to up to 20 weeks of Internet-delivered parent-child interaction therapy (iPCIT) or to referral as usual (RAU, the control group). The children were randomized after completion of early intervention services within 3 months of their third birthday, and participated in the sessions with a parent or caregiver. Most of the participants were from economically disadvantaged households and underrepresented ethnic backgrounds.
The iPCIT intervention was conducted weekly with a remote therapist and lasted for 1-1.5 hours; approximately half of the families received the intervention in Spanish.
The primary outcome was rating on the Child Behavior Checklist (CBCL) and assessment of children and caregivers using the Dyadic Parent-Child Interaction Coding System, fourth edition (DPICS). Assessments occurred at baseline and at week 20 (post treatment), with follow ups at 6 and 12 months.
Scores on the CBCL in the iPCIT group decreased from a mean of 61.18 at baseline to 53.83 post intervention. Scores for the control group started at 64.05 and decreased to 59.49 post intervention. At 6-12 months, the scores for both groups remained stable.
Children who received iPCIT with their parent or caregiver also showed significantly lower levels of externalizing behavior problems, compared with the RAU controls post treatment, and at 6-month and 12-month follow-ups based on the Cohen d measure of standardized effect size for differences between groups.
Significantly more children in the iPCIT group showed clinically significant improvements in externalizing problems at post treatment, compared with the RAU group (74% vs. 42%; P < .001) and at 6 months’ follow-up (73% vs. 45%; P = .002). However, the differences from baseline were not significantly different between the two groups after 12 months, which suggests that the effects may wane over time, the researchers noted.
In addition, the rate of child compliance with parent commands, as measured by a cleanup task, approximately doubled by the 12-month follow-up among children in the iPCIT group versus an increase of approximately one-third in the RAU group.
For secondary outcome measures related to caregiver behaviors, the proportion of observed positive parenting behaviors increased in the iPCIT group during the course of the intervention (postintervention odds ratio, 1.10), and the proportion of controlling and critical behaviors decreased (postintervention OR, 1.40). Harsh and inconsistent discipline decreased in both groups based on self-reports, but the decrease was steeper in iPCIT families.
iPCIT did not have a greater impact than RAU in reducing caregiver stress. The researchers wrote that they were not surprised by the lack of stress reduction “given mixed findings on the impact of parenting interventions on stress in caregivers of children with DD.”
Data support iPCIT potential
Overall, the results support findings from previous studies of clinic-based PCIT for children with DD and previous studies of telehealth interventions for typically developing children, the researchers said.
“Moreover, iPCIT-treated children not only showed reductions in behavior problems, such as aggression, but demonstrated higher rates of following directions, which is especially important for children entering kindergarten,” they wrote.
The findings were limited by several factors including the narrow focus on the primary and secondary outcomes, the use of data from a single site in a single metropolitan area – which may limit generalizability – and the lack of comparison between iPCIT and a clinic-based PCIT control group, the researchers noted. The equipment in the current study was provided to families; therefore, differences in treatment response could not be attributed to differences in technology.
The study represents the first known randomized controlled trial to evaluate a telehealth parenting intervention for children with, according to the researchers. The results suggest that technology can be leveraged to help these patients, including those from ethnic minority families who may be underserved by clinic-based care in overcoming barriers to treatment such as transportation and availability of clinicians. Use of iPCIT could be a critical resource as young children with DD complete Part C services and enter the school system.
Practical pediatric takeaways
“This was a great study, well-designed and very important and helpful for pediatric providers,” Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.
“Young children with developmental delay and/or mental and behavioral health disorders require early identification and intervention,” said Dr. Haut. However, obstacles to intervention include stigma or parental denial of the disorder, as well as more practical challenges related to transportation, time to access a clinic or office, potential long length of treatment, and cost.
“Despite availability of state programs for young children, follow up and continued services can be challenging to complete. Once the child outgrows the state program finding alternative therapy can be difficult with the current shortage of pediatric mental health providers,” Dr. Haut noted.
“I was surprised to see that this study treatment phase was completed prior to the COVID-19 pandemic, when telehealth was not as popular a mode for health care and was not utilized to the extent that it is now, especially for pediatric care,” said Dr. Haut. “I was not surprised at the results, as the traditional mode of PCIT includes therapy and training in a space that may not be as familiar to the child as their home environment, and would include live presence of the therapist/s, which may add to anxiety for both the parent and child.”
That almost half of the parents participating in the study had graduated from college and/or completed graduate degrees “may have contributed to some of the success of this study,” Dr. Haut noted.
Benefits and barriers
“The COVID-19 pandemic brought significant change to the frequency of use and overall success of telehealth services,” Dr. Haut said. “Additional provider education in aspects such as provider technique and the use of medical devices with improved specific health care technology assisted in advancing the experience and opportunity for successful telehealth visits. Telehealth therapy offers a cost-effective option for any pediatric patients and for providers, as the time and space commitment for the patient visit can be considerably less than live office visits.
“Unfortunately, there are still overall barriers that I have personally experienced with telehealth, including interruptions in connectivity, background noise, and lack of an available computer or tablet; and with the use of cell phones not always allowing full inclusion of the caregiver and child,” said Dr. Haut. Children with DD, behavioral problems, or other mental health disorders may pose challenges for parents to manage at home while simultaneously trying to fully focus on the therapy in an online setting.
Although the current study is encouraging, “larger studies focused on specific or individual pediatric mental health and/or behavioral disorders may offer more information for providers, and better document the success of telehealth delivery of services,” Dr. Haut said.
The study was supported by the National Institute of Child Health and Human Development. Dr. Bagner disclosed funding from the National Institutes of Health. He also disclosed personal fees from PCIT International to train clinicians in PCIT supported by a grant from the Florida Department of Children and Families outside the current study. Dr. Haut had no financial conflicts to disclose, but serves on the editorial advisory board of Pediatric News.
The children received the therapy with their parents or caregivers, who were more likely to demonstrate positive parenting behaviors than parents in the control group, authors of the new research published in JAMA Pediatrics found.
Approximately 13% of children have some form of developmental delay (DD) and more than half of these children also have at least one mental health disorder, which makes behavior problems a common and ongoing challenge, Daniel M. Bagner, PhD, a psychologist at Florida International University, Miami, and colleagues wrote.
Clinic-based interventions such as parent-child interaction therapy (PCIT) have been effective for improving behavior in children with DD, the researchers said. PCIT involves in-session caregiver coaching using a 1-way mirror and a wireless earpiece worn by the caregiver.
Barriers to the use of PCIT, especially in marginalized and low-income communities, include transportation, clinician shortages, and stigma-related concerns about a clinic visit, the researchers wrote. Technology now allows for Internet-delivered PCIT to reach more children and families, but its effectiveness for children with DD has not been well studied.
In the new study, the researchers randomized 150 children with DD and externalizing behavior problems to up to 20 weeks of Internet-delivered parent-child interaction therapy (iPCIT) or to referral as usual (RAU, the control group). The children were randomized after completion of early intervention services within 3 months of their third birthday, and participated in the sessions with a parent or caregiver. Most of the participants were from economically disadvantaged households and underrepresented ethnic backgrounds.
The iPCIT intervention was conducted weekly with a remote therapist and lasted for 1-1.5 hours; approximately half of the families received the intervention in Spanish.
The primary outcome was rating on the Child Behavior Checklist (CBCL) and assessment of children and caregivers using the Dyadic Parent-Child Interaction Coding System, fourth edition (DPICS). Assessments occurred at baseline and at week 20 (post treatment), with follow ups at 6 and 12 months.
Scores on the CBCL in the iPCIT group decreased from a mean of 61.18 at baseline to 53.83 post intervention. Scores for the control group started at 64.05 and decreased to 59.49 post intervention. At 6-12 months, the scores for both groups remained stable.
Children who received iPCIT with their parent or caregiver also showed significantly lower levels of externalizing behavior problems, compared with the RAU controls post treatment, and at 6-month and 12-month follow-ups based on the Cohen d measure of standardized effect size for differences between groups.
Significantly more children in the iPCIT group showed clinically significant improvements in externalizing problems at post treatment, compared with the RAU group (74% vs. 42%; P < .001) and at 6 months’ follow-up (73% vs. 45%; P = .002). However, the differences from baseline were not significantly different between the two groups after 12 months, which suggests that the effects may wane over time, the researchers noted.
In addition, the rate of child compliance with parent commands, as measured by a cleanup task, approximately doubled by the 12-month follow-up among children in the iPCIT group versus an increase of approximately one-third in the RAU group.
For secondary outcome measures related to caregiver behaviors, the proportion of observed positive parenting behaviors increased in the iPCIT group during the course of the intervention (postintervention odds ratio, 1.10), and the proportion of controlling and critical behaviors decreased (postintervention OR, 1.40). Harsh and inconsistent discipline decreased in both groups based on self-reports, but the decrease was steeper in iPCIT families.
iPCIT did not have a greater impact than RAU in reducing caregiver stress. The researchers wrote that they were not surprised by the lack of stress reduction “given mixed findings on the impact of parenting interventions on stress in caregivers of children with DD.”
Data support iPCIT potential
Overall, the results support findings from previous studies of clinic-based PCIT for children with DD and previous studies of telehealth interventions for typically developing children, the researchers said.
“Moreover, iPCIT-treated children not only showed reductions in behavior problems, such as aggression, but demonstrated higher rates of following directions, which is especially important for children entering kindergarten,” they wrote.
The findings were limited by several factors including the narrow focus on the primary and secondary outcomes, the use of data from a single site in a single metropolitan area – which may limit generalizability – and the lack of comparison between iPCIT and a clinic-based PCIT control group, the researchers noted. The equipment in the current study was provided to families; therefore, differences in treatment response could not be attributed to differences in technology.
The study represents the first known randomized controlled trial to evaluate a telehealth parenting intervention for children with, according to the researchers. The results suggest that technology can be leveraged to help these patients, including those from ethnic minority families who may be underserved by clinic-based care in overcoming barriers to treatment such as transportation and availability of clinicians. Use of iPCIT could be a critical resource as young children with DD complete Part C services and enter the school system.
Practical pediatric takeaways
“This was a great study, well-designed and very important and helpful for pediatric providers,” Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.
“Young children with developmental delay and/or mental and behavioral health disorders require early identification and intervention,” said Dr. Haut. However, obstacles to intervention include stigma or parental denial of the disorder, as well as more practical challenges related to transportation, time to access a clinic or office, potential long length of treatment, and cost.
“Despite availability of state programs for young children, follow up and continued services can be challenging to complete. Once the child outgrows the state program finding alternative therapy can be difficult with the current shortage of pediatric mental health providers,” Dr. Haut noted.
“I was surprised to see that this study treatment phase was completed prior to the COVID-19 pandemic, when telehealth was not as popular a mode for health care and was not utilized to the extent that it is now, especially for pediatric care,” said Dr. Haut. “I was not surprised at the results, as the traditional mode of PCIT includes therapy and training in a space that may not be as familiar to the child as their home environment, and would include live presence of the therapist/s, which may add to anxiety for both the parent and child.”
That almost half of the parents participating in the study had graduated from college and/or completed graduate degrees “may have contributed to some of the success of this study,” Dr. Haut noted.
Benefits and barriers
“The COVID-19 pandemic brought significant change to the frequency of use and overall success of telehealth services,” Dr. Haut said. “Additional provider education in aspects such as provider technique and the use of medical devices with improved specific health care technology assisted in advancing the experience and opportunity for successful telehealth visits. Telehealth therapy offers a cost-effective option for any pediatric patients and for providers, as the time and space commitment for the patient visit can be considerably less than live office visits.
“Unfortunately, there are still overall barriers that I have personally experienced with telehealth, including interruptions in connectivity, background noise, and lack of an available computer or tablet; and with the use of cell phones not always allowing full inclusion of the caregiver and child,” said Dr. Haut. Children with DD, behavioral problems, or other mental health disorders may pose challenges for parents to manage at home while simultaneously trying to fully focus on the therapy in an online setting.
Although the current study is encouraging, “larger studies focused on specific or individual pediatric mental health and/or behavioral disorders may offer more information for providers, and better document the success of telehealth delivery of services,” Dr. Haut said.
The study was supported by the National Institute of Child Health and Human Development. Dr. Bagner disclosed funding from the National Institutes of Health. He also disclosed personal fees from PCIT International to train clinicians in PCIT supported by a grant from the Florida Department of Children and Families outside the current study. Dr. Haut had no financial conflicts to disclose, but serves on the editorial advisory board of Pediatric News.
FROM JAMA PEDIATRICS
Obesity impacts peripheral airway reactivity, asthma
Peripheral airway response to methacholine was similar among obese adults with and without asthma, although forced expiratory volume was lower for those with asthma, based on data from 53 individuals.
Obesity remains a risk factor for asthma, and obese individuals with asthma tend to have worse control and more severe disease, compared with nonobese asthma patients, wrote Anne E. Dixon, BM, BCh, of the University of Vermont, Burlington, and colleagues.
Previous studies have shown that airway reactivity can occur in obese individuals without airway inflammation, but studies characterizing obese asthma based on lung function are lacking, they said. “Combining spirometry and oscillometry might reveal abnormalities in lung mechanics particularly pertinent to people with obesity and asthma,” the researchers noted.
In a cross-sectional study published in the journal CHEST, the researchers reviewed data from 31 obese adults with asthma and 22 obese adults without asthma. The participants were aged 18 years and older, with forced expiratory volume (FEV1) of at least 60% of predicted. All had class III obesity, with an average BMI of 47.2 kg/m2 for those with asthma and 46.7 kg/m2 for nonasthma controls. Demographic characteristics were similar between the groups.
Airway reactivity was defined as a 20% decrease in FEV1 and/or a 50% change in resistance or reactance at 5 Hz (R5 and X5), at a concentration of 16 mg/mL or less of methacholine. Patients were assessed using spirometry and oscillometry.
For those with asthma, the resistance at 5 Hz, measured by oscillometry, increased by 52% in response to the PC20 methacholine challenge, with an area under the reactance curve (AX) of 361%. For controls without asthma, the resistance at 5 Hz increased by 45%, with an AX of 268% in response to 16 mg/mL of methacholine.
This finding suggests that obesity predisposes individuals to peripheral airway reactivity regardless of asthma status, the researchers wrote in their discussion.
The researchers also identified two distinct groups of asthma patients categorized by respiratory system impedance based on more concordant vs. discordant bronchoconstriction in the central and peripheral airways. The baseline AX for these two groups was 11.8 and 46.7, respectively, with interquartile ranges of 9.9-23.4 and 23.2-53.7, respectively.
The discordant group included only women, and these patients reported significantly more gastroesophageal reflux, increased chest tightness, and more wheezing and asthma exacerbations than the concordant group, which may be related to air trapping, shown on previous studies of obese individuals with asthma, the researchers wrote.
The findings were limited by several factors, including the measurement of airway impedance only at the peak methacholine dose and the measurement of oscillometry after spirometry, the researchers noted. Other limitations included the relatively small study population at a single center, and the focus on obese individuals only.
More research is needed in larger and more diverse patient populations, but the results support the characterization of a subgroup of obese asthma patients with significant peripheral airway dysfunction, the researchers wrote.
“Oscillometry testing can reveal a physiologic phenotype of asthma in obesity that may be related to worse symptoms and more severe disease, and also reveal subclinical abnormalities in people with obesity, but without clinically diagnosed lung disease,” they concluded.
The study was supported in part by the National Institutes of Health. The researchers declared no financial conflicts.
A version of this article first appeared on Medscape.com.
Peripheral airway response to methacholine was similar among obese adults with and without asthma, although forced expiratory volume was lower for those with asthma, based on data from 53 individuals.
Obesity remains a risk factor for asthma, and obese individuals with asthma tend to have worse control and more severe disease, compared with nonobese asthma patients, wrote Anne E. Dixon, BM, BCh, of the University of Vermont, Burlington, and colleagues.
Previous studies have shown that airway reactivity can occur in obese individuals without airway inflammation, but studies characterizing obese asthma based on lung function are lacking, they said. “Combining spirometry and oscillometry might reveal abnormalities in lung mechanics particularly pertinent to people with obesity and asthma,” the researchers noted.
In a cross-sectional study published in the journal CHEST, the researchers reviewed data from 31 obese adults with asthma and 22 obese adults without asthma. The participants were aged 18 years and older, with forced expiratory volume (FEV1) of at least 60% of predicted. All had class III obesity, with an average BMI of 47.2 kg/m2 for those with asthma and 46.7 kg/m2 for nonasthma controls. Demographic characteristics were similar between the groups.
Airway reactivity was defined as a 20% decrease in FEV1 and/or a 50% change in resistance or reactance at 5 Hz (R5 and X5), at a concentration of 16 mg/mL or less of methacholine. Patients were assessed using spirometry and oscillometry.
For those with asthma, the resistance at 5 Hz, measured by oscillometry, increased by 52% in response to the PC20 methacholine challenge, with an area under the reactance curve (AX) of 361%. For controls without asthma, the resistance at 5 Hz increased by 45%, with an AX of 268% in response to 16 mg/mL of methacholine.
This finding suggests that obesity predisposes individuals to peripheral airway reactivity regardless of asthma status, the researchers wrote in their discussion.
The researchers also identified two distinct groups of asthma patients categorized by respiratory system impedance based on more concordant vs. discordant bronchoconstriction in the central and peripheral airways. The baseline AX for these two groups was 11.8 and 46.7, respectively, with interquartile ranges of 9.9-23.4 and 23.2-53.7, respectively.
The discordant group included only women, and these patients reported significantly more gastroesophageal reflux, increased chest tightness, and more wheezing and asthma exacerbations than the concordant group, which may be related to air trapping, shown on previous studies of obese individuals with asthma, the researchers wrote.
The findings were limited by several factors, including the measurement of airway impedance only at the peak methacholine dose and the measurement of oscillometry after spirometry, the researchers noted. Other limitations included the relatively small study population at a single center, and the focus on obese individuals only.
More research is needed in larger and more diverse patient populations, but the results support the characterization of a subgroup of obese asthma patients with significant peripheral airway dysfunction, the researchers wrote.
“Oscillometry testing can reveal a physiologic phenotype of asthma in obesity that may be related to worse symptoms and more severe disease, and also reveal subclinical abnormalities in people with obesity, but without clinically diagnosed lung disease,” they concluded.
The study was supported in part by the National Institutes of Health. The researchers declared no financial conflicts.
A version of this article first appeared on Medscape.com.
Peripheral airway response to methacholine was similar among obese adults with and without asthma, although forced expiratory volume was lower for those with asthma, based on data from 53 individuals.
Obesity remains a risk factor for asthma, and obese individuals with asthma tend to have worse control and more severe disease, compared with nonobese asthma patients, wrote Anne E. Dixon, BM, BCh, of the University of Vermont, Burlington, and colleagues.
Previous studies have shown that airway reactivity can occur in obese individuals without airway inflammation, but studies characterizing obese asthma based on lung function are lacking, they said. “Combining spirometry and oscillometry might reveal abnormalities in lung mechanics particularly pertinent to people with obesity and asthma,” the researchers noted.
In a cross-sectional study published in the journal CHEST, the researchers reviewed data from 31 obese adults with asthma and 22 obese adults without asthma. The participants were aged 18 years and older, with forced expiratory volume (FEV1) of at least 60% of predicted. All had class III obesity, with an average BMI of 47.2 kg/m2 for those with asthma and 46.7 kg/m2 for nonasthma controls. Demographic characteristics were similar between the groups.
Airway reactivity was defined as a 20% decrease in FEV1 and/or a 50% change in resistance or reactance at 5 Hz (R5 and X5), at a concentration of 16 mg/mL or less of methacholine. Patients were assessed using spirometry and oscillometry.
For those with asthma, the resistance at 5 Hz, measured by oscillometry, increased by 52% in response to the PC20 methacholine challenge, with an area under the reactance curve (AX) of 361%. For controls without asthma, the resistance at 5 Hz increased by 45%, with an AX of 268% in response to 16 mg/mL of methacholine.
This finding suggests that obesity predisposes individuals to peripheral airway reactivity regardless of asthma status, the researchers wrote in their discussion.
The researchers also identified two distinct groups of asthma patients categorized by respiratory system impedance based on more concordant vs. discordant bronchoconstriction in the central and peripheral airways. The baseline AX for these two groups was 11.8 and 46.7, respectively, with interquartile ranges of 9.9-23.4 and 23.2-53.7, respectively.
The discordant group included only women, and these patients reported significantly more gastroesophageal reflux, increased chest tightness, and more wheezing and asthma exacerbations than the concordant group, which may be related to air trapping, shown on previous studies of obese individuals with asthma, the researchers wrote.
The findings were limited by several factors, including the measurement of airway impedance only at the peak methacholine dose and the measurement of oscillometry after spirometry, the researchers noted. Other limitations included the relatively small study population at a single center, and the focus on obese individuals only.
More research is needed in larger and more diverse patient populations, but the results support the characterization of a subgroup of obese asthma patients with significant peripheral airway dysfunction, the researchers wrote.
“Oscillometry testing can reveal a physiologic phenotype of asthma in obesity that may be related to worse symptoms and more severe disease, and also reveal subclinical abnormalities in people with obesity, but without clinically diagnosed lung disease,” they concluded.
The study was supported in part by the National Institutes of Health. The researchers declared no financial conflicts.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL CHEST
Berdazimer gel under review at FDA for treating molluscum contagiosum
, the manufacturer announced.
If the submission is accepted by the FDA, the topical product could be approved in the first quarter of 2024, according to a press release from Novan, the manufacturer. If approved, it would be the first-in-class topical treatment for MC, the common, contagious viral skin infection that affects approximately six million individuals in the United States each year, most of them children aged 1-14 years, the statement noted. No FDA-approved therapies currently exist for the condition, which causes unsightly lesions on the face, trunk, limbs, and axillae that may persist untreated for a period of years.
The active ingredient in berdazimer gel 10.3% is berdazimer sodium, a nitric oxide–releasing agent. A 3.4% formulation is in development for the topical treatment of acne, according to the company.
The submission for FDA approval is based on data from the B-SIMPLE4 study, a phase 3 randomized trial of nearly 900 individuals with MC aged 6 months and older (mean age, 6.6 years), with 3-70 raised lesions. Participants were randomized to treatment with berdazimer gel 10.3% or a vehicle gel applied in a thin layer to all lesions once daily for 12 weeks. The results were published in JAMA Dermatology.
The primary outcome was complete clearance of all lesions. At 12 weeks, 32.4% of patients in the berdazimer group achieved this outcome vs. 19.7% of those in the vehicle group (P < .001). Overall adverse event rates were low in both groups; 4.1% of patients on berdazimer and 0.7% of those on the vehicle experienced adverse events that led to discontinuation of treatment. The most common adverse events across both groups were application-site pain and erythema, and most of these were mild or moderate.
, the manufacturer announced.
If the submission is accepted by the FDA, the topical product could be approved in the first quarter of 2024, according to a press release from Novan, the manufacturer. If approved, it would be the first-in-class topical treatment for MC, the common, contagious viral skin infection that affects approximately six million individuals in the United States each year, most of them children aged 1-14 years, the statement noted. No FDA-approved therapies currently exist for the condition, which causes unsightly lesions on the face, trunk, limbs, and axillae that may persist untreated for a period of years.
The active ingredient in berdazimer gel 10.3% is berdazimer sodium, a nitric oxide–releasing agent. A 3.4% formulation is in development for the topical treatment of acne, according to the company.
The submission for FDA approval is based on data from the B-SIMPLE4 study, a phase 3 randomized trial of nearly 900 individuals with MC aged 6 months and older (mean age, 6.6 years), with 3-70 raised lesions. Participants were randomized to treatment with berdazimer gel 10.3% or a vehicle gel applied in a thin layer to all lesions once daily for 12 weeks. The results were published in JAMA Dermatology.
The primary outcome was complete clearance of all lesions. At 12 weeks, 32.4% of patients in the berdazimer group achieved this outcome vs. 19.7% of those in the vehicle group (P < .001). Overall adverse event rates were low in both groups; 4.1% of patients on berdazimer and 0.7% of those on the vehicle experienced adverse events that led to discontinuation of treatment. The most common adverse events across both groups were application-site pain and erythema, and most of these were mild or moderate.
, the manufacturer announced.
If the submission is accepted by the FDA, the topical product could be approved in the first quarter of 2024, according to a press release from Novan, the manufacturer. If approved, it would be the first-in-class topical treatment for MC, the common, contagious viral skin infection that affects approximately six million individuals in the United States each year, most of them children aged 1-14 years, the statement noted. No FDA-approved therapies currently exist for the condition, which causes unsightly lesions on the face, trunk, limbs, and axillae that may persist untreated for a period of years.
The active ingredient in berdazimer gel 10.3% is berdazimer sodium, a nitric oxide–releasing agent. A 3.4% formulation is in development for the topical treatment of acne, according to the company.
The submission for FDA approval is based on data from the B-SIMPLE4 study, a phase 3 randomized trial of nearly 900 individuals with MC aged 6 months and older (mean age, 6.6 years), with 3-70 raised lesions. Participants were randomized to treatment with berdazimer gel 10.3% or a vehicle gel applied in a thin layer to all lesions once daily for 12 weeks. The results were published in JAMA Dermatology.
The primary outcome was complete clearance of all lesions. At 12 weeks, 32.4% of patients in the berdazimer group achieved this outcome vs. 19.7% of those in the vehicle group (P < .001). Overall adverse event rates were low in both groups; 4.1% of patients on berdazimer and 0.7% of those on the vehicle experienced adverse events that led to discontinuation of treatment. The most common adverse events across both groups were application-site pain and erythema, and most of these were mild or moderate.