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Diet packed with fast food found hard on the liver
The study finds that getting one-fifth or more of total daily calories from fast food can increase the risk of nonalcoholic fatty liver disease, which can lead to cirrhosis and its complications, including liver failure and liver cancer.
Although the magnitude of association was modest among the general population, “striking” elevations in steatosis were evident among persons with obesity and diabetes who consumed fast food, in comparison with their counterparts who did not have obesity and diabetes, the researchers reported.
“My hope is that this study encourages people to seek out more nutritious, healthy food options and provides information that clinicians can use to counsel their patients, particularly those with underlying metabolic risk factors, of the importance of avoiding foods that are high in fat, carbohydrates, and processed sugars,” lead investigator Ani Kardashian, MD, hepatologist with the University of Southern California, Los Angeles, said in an interview.
“At a policy level, public health efforts are needed to improve access to affordable, healthy, and nutritious food options across the U.S. This is especially important as more people have turned to fast foods during the pandemic and as the price of food as risen dramatically over the past year due to food inflation,” Dr. Kardashian added.
The study was published online in Clinical Gastroenterology and Hepatology.
More fast food, greater steatosis
The findings are based on data from 3,954 adults who participated in the National Health and Nutrition Examination Survey (NHANES) of 2017-2018 and who underwent vibration-controlled transient elastography. Of these participants, data regarding 1- or 2-day dietary recall were available.
Steatosis, the primary outcome, was measured via controlled attenuation parameter (CAP). Two validated cutoffs were utilized (CAP ≥ 263 dB/m and CAP ≥ 285 dB/m).
Of those surveyed, 52% consumed any fast food, and 29% derived 20% or more of their daily calories from fast food.
Fast-food intake of 20% or more of daily calories was significantly associated with greater steatosis after multivariable adjustment, both as a continuous measure (4.6 dB/m higher CAP score) and with respect to the CAP ≥ 263 dB/m cutoff (odds ratio [OR], 1.45).
“The negative effects are particularly severe in people who already have diabetes and obesity,” Dr. Kardashian told this news organization.
For example, with diabetes and fast-food intake of 20% or more of daily calories, the ORs of meeting the CAP ≥ 263 dB/m cutoff and the CAP ≥ 285 dB/m cutoff were 2.3 and 2.48, respectively.
The researchers said their findings are particularly “alarming,” given the overall increase in fast-food consumption over the past 50 years in the United States, regardless of socioeconomic status.
Diet coaching
The finding that fast food has more deleterious impact on those with obesity and diabetes “emphasizes that it is not just one insult but multiple factors that contribute to overall health,” said Nancy Reau, MD, section chief of hepatology at Rush University Medical Center in Chicago.
“This is actually great news, because diet is modifiable, vs. your genetics, which you currently can’t change. This doesn’t mean if you’re lean you can eat whatever you want, but if you are overweight, being careful with your diet does have impact, even if it doesn’t lead to substantial weight changes,” said Dr. Reau, who is not affiliated with the study.
For people who have limited options and need to eat fast food, “there are healthy choices at most restaurants; you just need to be smart about reading labels, watching calories, and ordering the healthier options,” Dr. Reau said in an interview.
Fast food and fatty liver go “hand in hand,” Lisa Ganjhu, DO, gastroenterologist and hepatologist at NYU Langone Health in New York, told this news organization.
“I counsel and coach my patients on healthy diet and exercise, and I’ve been pretty successful,” said Dr. Ganjhu, who was not involved with the study.
“If my patient is eating at McDonald’s a lot, I basically walk through the menu with them and help them find something healthy. When patients see the benefits of cutting out fat and reducing carbohydrates, they are more apt to continue,” Dr. Ganjhu said.
The study was funded by the University of Southern California. Dr. Kardashian, Dr. Reau, and Dr. Ganjhu have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The study finds that getting one-fifth or more of total daily calories from fast food can increase the risk of nonalcoholic fatty liver disease, which can lead to cirrhosis and its complications, including liver failure and liver cancer.
Although the magnitude of association was modest among the general population, “striking” elevations in steatosis were evident among persons with obesity and diabetes who consumed fast food, in comparison with their counterparts who did not have obesity and diabetes, the researchers reported.
“My hope is that this study encourages people to seek out more nutritious, healthy food options and provides information that clinicians can use to counsel their patients, particularly those with underlying metabolic risk factors, of the importance of avoiding foods that are high in fat, carbohydrates, and processed sugars,” lead investigator Ani Kardashian, MD, hepatologist with the University of Southern California, Los Angeles, said in an interview.
“At a policy level, public health efforts are needed to improve access to affordable, healthy, and nutritious food options across the U.S. This is especially important as more people have turned to fast foods during the pandemic and as the price of food as risen dramatically over the past year due to food inflation,” Dr. Kardashian added.
The study was published online in Clinical Gastroenterology and Hepatology.
More fast food, greater steatosis
The findings are based on data from 3,954 adults who participated in the National Health and Nutrition Examination Survey (NHANES) of 2017-2018 and who underwent vibration-controlled transient elastography. Of these participants, data regarding 1- or 2-day dietary recall were available.
Steatosis, the primary outcome, was measured via controlled attenuation parameter (CAP). Two validated cutoffs were utilized (CAP ≥ 263 dB/m and CAP ≥ 285 dB/m).
Of those surveyed, 52% consumed any fast food, and 29% derived 20% or more of their daily calories from fast food.
Fast-food intake of 20% or more of daily calories was significantly associated with greater steatosis after multivariable adjustment, both as a continuous measure (4.6 dB/m higher CAP score) and with respect to the CAP ≥ 263 dB/m cutoff (odds ratio [OR], 1.45).
“The negative effects are particularly severe in people who already have diabetes and obesity,” Dr. Kardashian told this news organization.
For example, with diabetes and fast-food intake of 20% or more of daily calories, the ORs of meeting the CAP ≥ 263 dB/m cutoff and the CAP ≥ 285 dB/m cutoff were 2.3 and 2.48, respectively.
The researchers said their findings are particularly “alarming,” given the overall increase in fast-food consumption over the past 50 years in the United States, regardless of socioeconomic status.
Diet coaching
The finding that fast food has more deleterious impact on those with obesity and diabetes “emphasizes that it is not just one insult but multiple factors that contribute to overall health,” said Nancy Reau, MD, section chief of hepatology at Rush University Medical Center in Chicago.
“This is actually great news, because diet is modifiable, vs. your genetics, which you currently can’t change. This doesn’t mean if you’re lean you can eat whatever you want, but if you are overweight, being careful with your diet does have impact, even if it doesn’t lead to substantial weight changes,” said Dr. Reau, who is not affiliated with the study.
For people who have limited options and need to eat fast food, “there are healthy choices at most restaurants; you just need to be smart about reading labels, watching calories, and ordering the healthier options,” Dr. Reau said in an interview.
Fast food and fatty liver go “hand in hand,” Lisa Ganjhu, DO, gastroenterologist and hepatologist at NYU Langone Health in New York, told this news organization.
“I counsel and coach my patients on healthy diet and exercise, and I’ve been pretty successful,” said Dr. Ganjhu, who was not involved with the study.
“If my patient is eating at McDonald’s a lot, I basically walk through the menu with them and help them find something healthy. When patients see the benefits of cutting out fat and reducing carbohydrates, they are more apt to continue,” Dr. Ganjhu said.
The study was funded by the University of Southern California. Dr. Kardashian, Dr. Reau, and Dr. Ganjhu have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The study finds that getting one-fifth or more of total daily calories from fast food can increase the risk of nonalcoholic fatty liver disease, which can lead to cirrhosis and its complications, including liver failure and liver cancer.
Although the magnitude of association was modest among the general population, “striking” elevations in steatosis were evident among persons with obesity and diabetes who consumed fast food, in comparison with their counterparts who did not have obesity and diabetes, the researchers reported.
“My hope is that this study encourages people to seek out more nutritious, healthy food options and provides information that clinicians can use to counsel their patients, particularly those with underlying metabolic risk factors, of the importance of avoiding foods that are high in fat, carbohydrates, and processed sugars,” lead investigator Ani Kardashian, MD, hepatologist with the University of Southern California, Los Angeles, said in an interview.
“At a policy level, public health efforts are needed to improve access to affordable, healthy, and nutritious food options across the U.S. This is especially important as more people have turned to fast foods during the pandemic and as the price of food as risen dramatically over the past year due to food inflation,” Dr. Kardashian added.
The study was published online in Clinical Gastroenterology and Hepatology.
More fast food, greater steatosis
The findings are based on data from 3,954 adults who participated in the National Health and Nutrition Examination Survey (NHANES) of 2017-2018 and who underwent vibration-controlled transient elastography. Of these participants, data regarding 1- or 2-day dietary recall were available.
Steatosis, the primary outcome, was measured via controlled attenuation parameter (CAP). Two validated cutoffs were utilized (CAP ≥ 263 dB/m and CAP ≥ 285 dB/m).
Of those surveyed, 52% consumed any fast food, and 29% derived 20% or more of their daily calories from fast food.
Fast-food intake of 20% or more of daily calories was significantly associated with greater steatosis after multivariable adjustment, both as a continuous measure (4.6 dB/m higher CAP score) and with respect to the CAP ≥ 263 dB/m cutoff (odds ratio [OR], 1.45).
“The negative effects are particularly severe in people who already have diabetes and obesity,” Dr. Kardashian told this news organization.
For example, with diabetes and fast-food intake of 20% or more of daily calories, the ORs of meeting the CAP ≥ 263 dB/m cutoff and the CAP ≥ 285 dB/m cutoff were 2.3 and 2.48, respectively.
The researchers said their findings are particularly “alarming,” given the overall increase in fast-food consumption over the past 50 years in the United States, regardless of socioeconomic status.
Diet coaching
The finding that fast food has more deleterious impact on those with obesity and diabetes “emphasizes that it is not just one insult but multiple factors that contribute to overall health,” said Nancy Reau, MD, section chief of hepatology at Rush University Medical Center in Chicago.
“This is actually great news, because diet is modifiable, vs. your genetics, which you currently can’t change. This doesn’t mean if you’re lean you can eat whatever you want, but if you are overweight, being careful with your diet does have impact, even if it doesn’t lead to substantial weight changes,” said Dr. Reau, who is not affiliated with the study.
For people who have limited options and need to eat fast food, “there are healthy choices at most restaurants; you just need to be smart about reading labels, watching calories, and ordering the healthier options,” Dr. Reau said in an interview.
Fast food and fatty liver go “hand in hand,” Lisa Ganjhu, DO, gastroenterologist and hepatologist at NYU Langone Health in New York, told this news organization.
“I counsel and coach my patients on healthy diet and exercise, and I’ve been pretty successful,” said Dr. Ganjhu, who was not involved with the study.
“If my patient is eating at McDonald’s a lot, I basically walk through the menu with them and help them find something healthy. When patients see the benefits of cutting out fat and reducing carbohydrates, they are more apt to continue,” Dr. Ganjhu said.
The study was funded by the University of Southern California. Dr. Kardashian, Dr. Reau, and Dr. Ganjhu have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
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
Best estimates made for hydroxychloroquine retinopathy risk
A new study likely makes the best estimate yet of the degree of retinopathy risk that patients who take the antimalarial drug hydroxychloroquine (HCQ) can expect, deriving mainly from the cumulative dose taken during the first 5 years of use, according to a study published in Annals of Internal Medicine.
HCQ works to decrease activity in a patient’s immune system, which is effective in many cases of systemic lupus erythematosus, one of the most common indications for the drug. However, an adverse outcome of treatment can be HCQ retinopathy, a progressive form of vision loss in patients taking HCQ over an extended period (mostly for longer than 5 years). The disease is often asymptomatic, although some patients do present a paracentral scotoma and a decrease in color vision. Patients may also notice flashing shapes in their vision and find that they have difficulty reading. Eventually, HCQ retinopathy can lead to loss of visual acuity, loss of peripheral vision, and loss of night vision.
Researchers from Kaiser Permanente Northern California and Harvard Medical School analyzed 3,325 persons who received HCQ for 5 or more years between 2004 and 2020. Their goal was to both characterize the long-term risk for incident HCQ retinopathy and examine the degree to which average HCQ dose within the first 5 years of treatment serves as a prediction of the risk.
The researchers then estimated the risk for developing retinopathy after 15 years, according to patients’ average dosing levels during the first 5 years of therapy. Overall, 81 participants developed HCQ retinopathy with overall cumulative incidences of 2.5% after 10 years and 8.6% after 15 years; the risk was greater for those given a higher dose during the first 5 years of treatment.
The mechanism of how HCQ toxicity may occur is still not completely known. There is evidence that toxicity happens because HCQ binds to melanin in both the retinal pigment epithelium and uvea in high concentrations. HCQ can interfere with lysosomal function, leading to oxidation and accumulation of lysosomes, which can cause dysfunction of the retinal pigment epithelium.
Progressive retinopathy can continue even after the drug is stopped. “It’s thought to be a very mild but important risk,” said Nilanjana Bose, MD, MBA, a rheumatologist with Memorial Hermann Health System in Houston. “Patients taking HCQ must be screened for retinal issues, most certainly elderly patients and patients with any kind of comorbidities.”
A 2021 joint position statement from the American College of Rheumatology, American Academy of Dermatology, the Rheumatologic Dermatology Society, and the American Academy of Ophthalmology recommends a baseline eye exam within a few months after starting therapy, then additional screening at 5 years on HCQ and annually thereafter.
“Early detection of retinopathy is important in overall visual prognosis, because toxicity can continue even after discontinuation of the medication,” said Rukhsana G. Mirza, MD, professor of ophthalmology and medical education at Northwestern University in Chicago.
“Examination alone is not sufficient to evaluate early changes, and specialized testing must be done. These include color photos, visual field tests, optical coherence tomography, fundus autofluorescence and in some cases, multifocal electroretinogram. Also, the AAO [American Academy of Ophthalmology] has specific recommendations related to Asian patients as they may have a different pattern of retinopathy that must also be considered.”
More accurate risk measurements
This news organization asked study coauthor April Jorge, MD, assistant professor of medicine in the division of rheumatology, allergy, and immunology at Massachusetts General Hospital and Harvard Medical School, Boston, to discuss the study, how it correlates to past research, and what it adds that’s new and useful to rheumatologists and ophthalmologists:
Question: Your research found that a higher dose of HCQ in the first 5 years of treatment led to a greater risk of retinopathy. Is there any indication that a lower dose given more frequently, either within that 5-year period or longer, would pose a similar risk?
Answer: In our study, we assessed the HCQ dose in the first 5 years of use but followed patients who continued the medication longer than 5 years, through up to 15 years of use. Therefore, we compared the risk of HCQ retinopathy associated with different HCQ dosages but for the same duration of use. We found that for any dose of HCQ, the risk of retinopathy increases the longer the medication is used. However, patients who used a higher dose of HCQ had a higher risk of developing retinopathy over time.
Although current guidelines recommend avoiding any HCQ dose over 5 mg/kg per day to reduce the risk of retinopathy, we found a higher risk of retinopathy associated with dosing over 6 mg/kg per day than between 5 and 6 mg/kg per day and the lowest risk with dosing under 5 mg/kg per day.
Q: How does your study align with and/or expand upon previous research regarding HCQ risk?
A: An important prior study of hydroxychloroquine retinopathy was the 2014 study by Ronald B. Melles, MD, and Michael F. Marmor, MD, published in JAMA Ophthalmology. Prior to our present study, that was the largest study to use the modern screening method (optical coherence tomography) to detect HCQ retinopathy. That screening tool is more sensitive than older methods, so it can detect early/mild cases of retinopathy that are typically asymptomatic. Compared to older studies, that 2014 study found a much higher risk of HCQ retinopathy than was previously appreciated.
However, that 2014 study did have some key limitations that could affect the risk estimates, such as using prevalent cases. A key feature of our present study is that we took several important steps to generate more accurate risk estimates. This included using an incident user cohort and detecting incident retinopathy cases through serial review of optical coherence tomography (screening) studies.
To achieve a high degree of methodologic rigor in correctly identifying retinopathy outcomes, we had expert ophthalmologists perform masked adjudication of all screening studies, and we assessed the intra-rater reliability of these study interpretations. Therefore, our study adds to the literature more accurate estimates of retinopathy risk. We found a lower cumulative incidence of retinopathy than was identified in the 2014 study, but the risk is still noteworthy.
Also unique to our study, we graded the severity of HCQ retinopathy outcomes. This was important, as we found that the majority of retinopathy cases detected through routine screening are mild and presumed to be asymptomatic. This will likely be reassuring news for patients that we can screen for this adverse event to detect it early and prevent vision loss.
Another important difference was that we assessed the risk of retinopathy associated with using over 6 mg/kg per day, between 5 and 6 mg/kg per day, and less than 5 mg/kg per day, whereas the highest dosing group assessed in the 2014 study included all patients using over 5 mg/kg per day. The risk was considerably higher in the > 6 mg/kg per day group than in the 5-6 mg/kg per day group.
Q: How can rheumatologists and ophthalmologists use this new information specifically to better treat their patients?
A: Our study provides more accurate estimates of the risk of HCQ retinopathy than in prior studies. These risk estimates can be used when rheumatologists (and other clinicians who prescribe HCQ) consider the risks and benefits of this otherwise important and well-tolerated medication. The risk associated with different dose ranges could also inform dosing decisions, since dosing over 6 mg/kg per day may be more of a concern than using doses in the 5-6 mg/kg range. Ophthalmologists can also use these new risk estimates to counsel patients of the importance of HCQ retinopathy screening and can also hopefully provide some reassurance to patients that the risk of severe retinopathy is low as long as they are being monitored.
The study authors were supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Rheumatology Research Foundation. The authors report no relevant financial relationships. Dr. Bose and Dr. Mirza had no relevant disclosures.
A version of this article first appeared on Medscape.com.
A new study likely makes the best estimate yet of the degree of retinopathy risk that patients who take the antimalarial drug hydroxychloroquine (HCQ) can expect, deriving mainly from the cumulative dose taken during the first 5 years of use, according to a study published in Annals of Internal Medicine.
HCQ works to decrease activity in a patient’s immune system, which is effective in many cases of systemic lupus erythematosus, one of the most common indications for the drug. However, an adverse outcome of treatment can be HCQ retinopathy, a progressive form of vision loss in patients taking HCQ over an extended period (mostly for longer than 5 years). The disease is often asymptomatic, although some patients do present a paracentral scotoma and a decrease in color vision. Patients may also notice flashing shapes in their vision and find that they have difficulty reading. Eventually, HCQ retinopathy can lead to loss of visual acuity, loss of peripheral vision, and loss of night vision.
Researchers from Kaiser Permanente Northern California and Harvard Medical School analyzed 3,325 persons who received HCQ for 5 or more years between 2004 and 2020. Their goal was to both characterize the long-term risk for incident HCQ retinopathy and examine the degree to which average HCQ dose within the first 5 years of treatment serves as a prediction of the risk.
The researchers then estimated the risk for developing retinopathy after 15 years, according to patients’ average dosing levels during the first 5 years of therapy. Overall, 81 participants developed HCQ retinopathy with overall cumulative incidences of 2.5% after 10 years and 8.6% after 15 years; the risk was greater for those given a higher dose during the first 5 years of treatment.
The mechanism of how HCQ toxicity may occur is still not completely known. There is evidence that toxicity happens because HCQ binds to melanin in both the retinal pigment epithelium and uvea in high concentrations. HCQ can interfere with lysosomal function, leading to oxidation and accumulation of lysosomes, which can cause dysfunction of the retinal pigment epithelium.
Progressive retinopathy can continue even after the drug is stopped. “It’s thought to be a very mild but important risk,” said Nilanjana Bose, MD, MBA, a rheumatologist with Memorial Hermann Health System in Houston. “Patients taking HCQ must be screened for retinal issues, most certainly elderly patients and patients with any kind of comorbidities.”
A 2021 joint position statement from the American College of Rheumatology, American Academy of Dermatology, the Rheumatologic Dermatology Society, and the American Academy of Ophthalmology recommends a baseline eye exam within a few months after starting therapy, then additional screening at 5 years on HCQ and annually thereafter.
“Early detection of retinopathy is important in overall visual prognosis, because toxicity can continue even after discontinuation of the medication,” said Rukhsana G. Mirza, MD, professor of ophthalmology and medical education at Northwestern University in Chicago.
“Examination alone is not sufficient to evaluate early changes, and specialized testing must be done. These include color photos, visual field tests, optical coherence tomography, fundus autofluorescence and in some cases, multifocal electroretinogram. Also, the AAO [American Academy of Ophthalmology] has specific recommendations related to Asian patients as they may have a different pattern of retinopathy that must also be considered.”
More accurate risk measurements
This news organization asked study coauthor April Jorge, MD, assistant professor of medicine in the division of rheumatology, allergy, and immunology at Massachusetts General Hospital and Harvard Medical School, Boston, to discuss the study, how it correlates to past research, and what it adds that’s new and useful to rheumatologists and ophthalmologists:
Question: Your research found that a higher dose of HCQ in the first 5 years of treatment led to a greater risk of retinopathy. Is there any indication that a lower dose given more frequently, either within that 5-year period or longer, would pose a similar risk?
Answer: In our study, we assessed the HCQ dose in the first 5 years of use but followed patients who continued the medication longer than 5 years, through up to 15 years of use. Therefore, we compared the risk of HCQ retinopathy associated with different HCQ dosages but for the same duration of use. We found that for any dose of HCQ, the risk of retinopathy increases the longer the medication is used. However, patients who used a higher dose of HCQ had a higher risk of developing retinopathy over time.
Although current guidelines recommend avoiding any HCQ dose over 5 mg/kg per day to reduce the risk of retinopathy, we found a higher risk of retinopathy associated with dosing over 6 mg/kg per day than between 5 and 6 mg/kg per day and the lowest risk with dosing under 5 mg/kg per day.
Q: How does your study align with and/or expand upon previous research regarding HCQ risk?
A: An important prior study of hydroxychloroquine retinopathy was the 2014 study by Ronald B. Melles, MD, and Michael F. Marmor, MD, published in JAMA Ophthalmology. Prior to our present study, that was the largest study to use the modern screening method (optical coherence tomography) to detect HCQ retinopathy. That screening tool is more sensitive than older methods, so it can detect early/mild cases of retinopathy that are typically asymptomatic. Compared to older studies, that 2014 study found a much higher risk of HCQ retinopathy than was previously appreciated.
However, that 2014 study did have some key limitations that could affect the risk estimates, such as using prevalent cases. A key feature of our present study is that we took several important steps to generate more accurate risk estimates. This included using an incident user cohort and detecting incident retinopathy cases through serial review of optical coherence tomography (screening) studies.
To achieve a high degree of methodologic rigor in correctly identifying retinopathy outcomes, we had expert ophthalmologists perform masked adjudication of all screening studies, and we assessed the intra-rater reliability of these study interpretations. Therefore, our study adds to the literature more accurate estimates of retinopathy risk. We found a lower cumulative incidence of retinopathy than was identified in the 2014 study, but the risk is still noteworthy.
Also unique to our study, we graded the severity of HCQ retinopathy outcomes. This was important, as we found that the majority of retinopathy cases detected through routine screening are mild and presumed to be asymptomatic. This will likely be reassuring news for patients that we can screen for this adverse event to detect it early and prevent vision loss.
Another important difference was that we assessed the risk of retinopathy associated with using over 6 mg/kg per day, between 5 and 6 mg/kg per day, and less than 5 mg/kg per day, whereas the highest dosing group assessed in the 2014 study included all patients using over 5 mg/kg per day. The risk was considerably higher in the > 6 mg/kg per day group than in the 5-6 mg/kg per day group.
Q: How can rheumatologists and ophthalmologists use this new information specifically to better treat their patients?
A: Our study provides more accurate estimates of the risk of HCQ retinopathy than in prior studies. These risk estimates can be used when rheumatologists (and other clinicians who prescribe HCQ) consider the risks and benefits of this otherwise important and well-tolerated medication. The risk associated with different dose ranges could also inform dosing decisions, since dosing over 6 mg/kg per day may be more of a concern than using doses in the 5-6 mg/kg range. Ophthalmologists can also use these new risk estimates to counsel patients of the importance of HCQ retinopathy screening and can also hopefully provide some reassurance to patients that the risk of severe retinopathy is low as long as they are being monitored.
The study authors were supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Rheumatology Research Foundation. The authors report no relevant financial relationships. Dr. Bose and Dr. Mirza had no relevant disclosures.
A version of this article first appeared on Medscape.com.
A new study likely makes the best estimate yet of the degree of retinopathy risk that patients who take the antimalarial drug hydroxychloroquine (HCQ) can expect, deriving mainly from the cumulative dose taken during the first 5 years of use, according to a study published in Annals of Internal Medicine.
HCQ works to decrease activity in a patient’s immune system, which is effective in many cases of systemic lupus erythematosus, one of the most common indications for the drug. However, an adverse outcome of treatment can be HCQ retinopathy, a progressive form of vision loss in patients taking HCQ over an extended period (mostly for longer than 5 years). The disease is often asymptomatic, although some patients do present a paracentral scotoma and a decrease in color vision. Patients may also notice flashing shapes in their vision and find that they have difficulty reading. Eventually, HCQ retinopathy can lead to loss of visual acuity, loss of peripheral vision, and loss of night vision.
Researchers from Kaiser Permanente Northern California and Harvard Medical School analyzed 3,325 persons who received HCQ for 5 or more years between 2004 and 2020. Their goal was to both characterize the long-term risk for incident HCQ retinopathy and examine the degree to which average HCQ dose within the first 5 years of treatment serves as a prediction of the risk.
The researchers then estimated the risk for developing retinopathy after 15 years, according to patients’ average dosing levels during the first 5 years of therapy. Overall, 81 participants developed HCQ retinopathy with overall cumulative incidences of 2.5% after 10 years and 8.6% after 15 years; the risk was greater for those given a higher dose during the first 5 years of treatment.
The mechanism of how HCQ toxicity may occur is still not completely known. There is evidence that toxicity happens because HCQ binds to melanin in both the retinal pigment epithelium and uvea in high concentrations. HCQ can interfere with lysosomal function, leading to oxidation and accumulation of lysosomes, which can cause dysfunction of the retinal pigment epithelium.
Progressive retinopathy can continue even after the drug is stopped. “It’s thought to be a very mild but important risk,” said Nilanjana Bose, MD, MBA, a rheumatologist with Memorial Hermann Health System in Houston. “Patients taking HCQ must be screened for retinal issues, most certainly elderly patients and patients with any kind of comorbidities.”
A 2021 joint position statement from the American College of Rheumatology, American Academy of Dermatology, the Rheumatologic Dermatology Society, and the American Academy of Ophthalmology recommends a baseline eye exam within a few months after starting therapy, then additional screening at 5 years on HCQ and annually thereafter.
“Early detection of retinopathy is important in overall visual prognosis, because toxicity can continue even after discontinuation of the medication,” said Rukhsana G. Mirza, MD, professor of ophthalmology and medical education at Northwestern University in Chicago.
“Examination alone is not sufficient to evaluate early changes, and specialized testing must be done. These include color photos, visual field tests, optical coherence tomography, fundus autofluorescence and in some cases, multifocal electroretinogram. Also, the AAO [American Academy of Ophthalmology] has specific recommendations related to Asian patients as they may have a different pattern of retinopathy that must also be considered.”
More accurate risk measurements
This news organization asked study coauthor April Jorge, MD, assistant professor of medicine in the division of rheumatology, allergy, and immunology at Massachusetts General Hospital and Harvard Medical School, Boston, to discuss the study, how it correlates to past research, and what it adds that’s new and useful to rheumatologists and ophthalmologists:
Question: Your research found that a higher dose of HCQ in the first 5 years of treatment led to a greater risk of retinopathy. Is there any indication that a lower dose given more frequently, either within that 5-year period or longer, would pose a similar risk?
Answer: In our study, we assessed the HCQ dose in the first 5 years of use but followed patients who continued the medication longer than 5 years, through up to 15 years of use. Therefore, we compared the risk of HCQ retinopathy associated with different HCQ dosages but for the same duration of use. We found that for any dose of HCQ, the risk of retinopathy increases the longer the medication is used. However, patients who used a higher dose of HCQ had a higher risk of developing retinopathy over time.
Although current guidelines recommend avoiding any HCQ dose over 5 mg/kg per day to reduce the risk of retinopathy, we found a higher risk of retinopathy associated with dosing over 6 mg/kg per day than between 5 and 6 mg/kg per day and the lowest risk with dosing under 5 mg/kg per day.
Q: How does your study align with and/or expand upon previous research regarding HCQ risk?
A: An important prior study of hydroxychloroquine retinopathy was the 2014 study by Ronald B. Melles, MD, and Michael F. Marmor, MD, published in JAMA Ophthalmology. Prior to our present study, that was the largest study to use the modern screening method (optical coherence tomography) to detect HCQ retinopathy. That screening tool is more sensitive than older methods, so it can detect early/mild cases of retinopathy that are typically asymptomatic. Compared to older studies, that 2014 study found a much higher risk of HCQ retinopathy than was previously appreciated.
However, that 2014 study did have some key limitations that could affect the risk estimates, such as using prevalent cases. A key feature of our present study is that we took several important steps to generate more accurate risk estimates. This included using an incident user cohort and detecting incident retinopathy cases through serial review of optical coherence tomography (screening) studies.
To achieve a high degree of methodologic rigor in correctly identifying retinopathy outcomes, we had expert ophthalmologists perform masked adjudication of all screening studies, and we assessed the intra-rater reliability of these study interpretations. Therefore, our study adds to the literature more accurate estimates of retinopathy risk. We found a lower cumulative incidence of retinopathy than was identified in the 2014 study, but the risk is still noteworthy.
Also unique to our study, we graded the severity of HCQ retinopathy outcomes. This was important, as we found that the majority of retinopathy cases detected through routine screening are mild and presumed to be asymptomatic. This will likely be reassuring news for patients that we can screen for this adverse event to detect it early and prevent vision loss.
Another important difference was that we assessed the risk of retinopathy associated with using over 6 mg/kg per day, between 5 and 6 mg/kg per day, and less than 5 mg/kg per day, whereas the highest dosing group assessed in the 2014 study included all patients using over 5 mg/kg per day. The risk was considerably higher in the > 6 mg/kg per day group than in the 5-6 mg/kg per day group.
Q: How can rheumatologists and ophthalmologists use this new information specifically to better treat their patients?
A: Our study provides more accurate estimates of the risk of HCQ retinopathy than in prior studies. These risk estimates can be used when rheumatologists (and other clinicians who prescribe HCQ) consider the risks and benefits of this otherwise important and well-tolerated medication. The risk associated with different dose ranges could also inform dosing decisions, since dosing over 6 mg/kg per day may be more of a concern than using doses in the 5-6 mg/kg range. Ophthalmologists can also use these new risk estimates to counsel patients of the importance of HCQ retinopathy screening and can also hopefully provide some reassurance to patients that the risk of severe retinopathy is low as long as they are being monitored.
The study authors were supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Rheumatology Research Foundation. The authors report no relevant financial relationships. Dr. Bose and Dr. Mirza had no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM ANNALS OF INTERNAL MEDICINE
HRT may prevent Alzheimer’s in high-risk women
new research suggests.
Results from a cohort study of almost 1,200 women showed that use of HRT was associated with higher delayed memory scores and larger entorhinal and hippocampal brain volumes – areas that are affected early by Alzheimer’s disease (AD) pathology.
HRT was also found to be most effective, as seen by larger hippocampal volume, when introduced during early perimenopause.
“Clinicians are very much aware of the susceptibility of women to cognitive disturbances during menopause,” lead author Rasha Saleh, MD, senior research associate, University of East Anglia (England), said in an interview.
“Identifying the at-risk APOE4 women and early HRT introduction can be of benefit. Confirming our findings in a clinical trial would be the next step forward,” Dr. Saleh said.
The findings were published online in Alzheimer’s Research and Therapy.
Personalized approaches
Dr. Saleh noted that estrogen receptors are localized in various areas of the brain, including cognition-related areas. Estrogen regulates such things as neuroinflammatory status, glucose utilization, and lipid metabolism.
“The decline of estrogen during menopause can lead to disturbance in these functions, which can accelerate AD-related pathology,” she said.
HRT during the menopausal transition and afterward is “being considered as a strategy to mitigate cognitive decline,” the investigators wrote. Early observational studies have suggested that oral estrogen “may be protective against dementia,” but results of clinical trials have been inconsistent, and some have even shown “harmful effects.”
The current researchers were “interested in the personalized approaches in the prevention of AD,” Dr. Saleh said. Preclinical and pilot data from her group have shown that women with APOE4 have “better cognitive test scores with nutritional and hormonal interventions.”
This led Dr. Saleh to hypothesize that HRT would be of more cognitive benefit for those with versus without APOE4, particularly when introduced early during the menopausal transition.
To investigate this hypothesis, the researchers analyzed baseline data from participants in the European Prevention of Alzheimer’s Dementia (EPAD) cohort. This project was initiated in 2015 with the aim of developing longitudinal models over the entire course of AD prior to dementia clinical diagnosis.
Participants were recruited from 10 European countries. All were required to be at least 50 years old, to have not been diagnosed with dementia at baseline, and to have no medical or psychiatric illness that could potentially exclude them from further research.
The current study included 1,178 women (mean age, 65.1 years), who were divided by genotype into non-APOE4 and APOE4 groups. HRT treatment for current or previous users included estrogen alone or estrogen plus progestogens via oral or transdermal administration routes, and at different doses.
The four tests used to assess cognition were the Mini-Mental State Examination dot counting to evaluate verbal working memory, the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total score, the Four Mountain Test, and the supermarket trolley virtual reality test.
Brain MRI data were collected. The researchers focused on the medial temporal lobe as the “main brain region regulating cognition and memory processing.” This lobe includes the hippocampus, the parahippocampus, the entorhinal cortex, and the amygdala.
‘Critical window’
The researchers found a “trend” toward an APOE-HRT interaction (P-interaction = .097) for the total RBANS score. In particular, it was significant for the RBANS delayed memory index, where scores were consistently higher for women with APOE4 who had received HRT, compared with all other groups (P-interaction = .009).
Within-genotype group comparisons showed that HRT users had a higher RBANS total scale score and delayed memory index (P = .045 and P = .002, respectively), but only among APOE4 carriers. Effect size analyses showed a large effect of HRT use on the Four Mountain Test score and the supermarket trolley virtual reality test score (Cohen’s d = 0.988 and 1.2, respectively).
“This large effect was found only in APOE4 carriers,” the investigators noted.
Similarly, a moderate to large effect of HRT on the left entorhinal volume was observed in APOE4 carriers (Cohen’s d = 0.63).
In members of the APOE4 group who received HRT, the left entorhinal and left and right amygdala volumes were larger, compared with both no-APOE4 and non-HRT users (P-interaction = .002, .003, and .005, respectively). Similar trends were observed for the right entorhinal volume (P = .074).
In addition, among HRT users, the left entorhinal volume was larger (P = .03); the right and left anterior cingulate gyrus volumes were smaller (P = .003 and .062, respectively); and the left superior frontal gyrus volume was larger (P = .009) in comparison with women who did not receive HRT, independently of their APOE genotype.
Early use of HRT among APOE4 carriers was associated with larger right and left hippocampal volume (P = .035 and P = .028, respectively) – an association not found in non-APOE4 carriers. The association was also not significant when participants were not stratified by APOE genotype.
“The key important point here is the timing, or the ‘critical window,’ when HRT can be of most benefit,” Dr. Saleh said. “This is most beneficial when introduced early, before the neuropathology becomes irreversible.”
Study limitations include its cross-sectional design, which precludes the establishment of a causal relationship, and the fact that information regarding the type and dose of estrogen was not available for all participants.
HRT is not without risk, Dr. Saleh noted. She recommended that clinicians “carry out various screening tests to make sure that a woman is eligible for HRT and not at risk of hypercoagulability, for instance.”
Risk-benefit ratio
In a comment, Howard Fillit, MD, cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, called the study “exactly the kind of work that needs to be done.”
Dr. Fillit, who was not involved with the current research, is a clinical professor of geriatric medicine, palliative care medicine, and neuroscience at Mount Sinai Hospital, New York.
He compared the process with that of osteoporosis. “We know that if women are treated [with HRT] at the time of the menopause, you can prevent the rapid bone loss that occurs with rapid estrogen loss. But if you wait 5, 10 years out, once the bone loss has occurred, the HRT doesn’t really have any impact on osteoporosis risk because the horse is already out of the barn,” he said.
Although HRT carries risks, “they can clearly be managed; and if it’s proven that estrogen or hormone replacement around the time of the menopause can be protective [against AD], the risk-benefit ratio of HRT could be in favor of treatment,” Dr. Fillit added.
The study was conducted as part of the Medical Research Council NuBrain Consortium. The investigators and Dr. Fillit reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
new research suggests.
Results from a cohort study of almost 1,200 women showed that use of HRT was associated with higher delayed memory scores and larger entorhinal and hippocampal brain volumes – areas that are affected early by Alzheimer’s disease (AD) pathology.
HRT was also found to be most effective, as seen by larger hippocampal volume, when introduced during early perimenopause.
“Clinicians are very much aware of the susceptibility of women to cognitive disturbances during menopause,” lead author Rasha Saleh, MD, senior research associate, University of East Anglia (England), said in an interview.
“Identifying the at-risk APOE4 women and early HRT introduction can be of benefit. Confirming our findings in a clinical trial would be the next step forward,” Dr. Saleh said.
The findings were published online in Alzheimer’s Research and Therapy.
Personalized approaches
Dr. Saleh noted that estrogen receptors are localized in various areas of the brain, including cognition-related areas. Estrogen regulates such things as neuroinflammatory status, glucose utilization, and lipid metabolism.
“The decline of estrogen during menopause can lead to disturbance in these functions, which can accelerate AD-related pathology,” she said.
HRT during the menopausal transition and afterward is “being considered as a strategy to mitigate cognitive decline,” the investigators wrote. Early observational studies have suggested that oral estrogen “may be protective against dementia,” but results of clinical trials have been inconsistent, and some have even shown “harmful effects.”
The current researchers were “interested in the personalized approaches in the prevention of AD,” Dr. Saleh said. Preclinical and pilot data from her group have shown that women with APOE4 have “better cognitive test scores with nutritional and hormonal interventions.”
This led Dr. Saleh to hypothesize that HRT would be of more cognitive benefit for those with versus without APOE4, particularly when introduced early during the menopausal transition.
To investigate this hypothesis, the researchers analyzed baseline data from participants in the European Prevention of Alzheimer’s Dementia (EPAD) cohort. This project was initiated in 2015 with the aim of developing longitudinal models over the entire course of AD prior to dementia clinical diagnosis.
Participants were recruited from 10 European countries. All were required to be at least 50 years old, to have not been diagnosed with dementia at baseline, and to have no medical or psychiatric illness that could potentially exclude them from further research.
The current study included 1,178 women (mean age, 65.1 years), who were divided by genotype into non-APOE4 and APOE4 groups. HRT treatment for current or previous users included estrogen alone or estrogen plus progestogens via oral or transdermal administration routes, and at different doses.
The four tests used to assess cognition were the Mini-Mental State Examination dot counting to evaluate verbal working memory, the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total score, the Four Mountain Test, and the supermarket trolley virtual reality test.
Brain MRI data were collected. The researchers focused on the medial temporal lobe as the “main brain region regulating cognition and memory processing.” This lobe includes the hippocampus, the parahippocampus, the entorhinal cortex, and the amygdala.
‘Critical window’
The researchers found a “trend” toward an APOE-HRT interaction (P-interaction = .097) for the total RBANS score. In particular, it was significant for the RBANS delayed memory index, where scores were consistently higher for women with APOE4 who had received HRT, compared with all other groups (P-interaction = .009).
Within-genotype group comparisons showed that HRT users had a higher RBANS total scale score and delayed memory index (P = .045 and P = .002, respectively), but only among APOE4 carriers. Effect size analyses showed a large effect of HRT use on the Four Mountain Test score and the supermarket trolley virtual reality test score (Cohen’s d = 0.988 and 1.2, respectively).
“This large effect was found only in APOE4 carriers,” the investigators noted.
Similarly, a moderate to large effect of HRT on the left entorhinal volume was observed in APOE4 carriers (Cohen’s d = 0.63).
In members of the APOE4 group who received HRT, the left entorhinal and left and right amygdala volumes were larger, compared with both no-APOE4 and non-HRT users (P-interaction = .002, .003, and .005, respectively). Similar trends were observed for the right entorhinal volume (P = .074).
In addition, among HRT users, the left entorhinal volume was larger (P = .03); the right and left anterior cingulate gyrus volumes were smaller (P = .003 and .062, respectively); and the left superior frontal gyrus volume was larger (P = .009) in comparison with women who did not receive HRT, independently of their APOE genotype.
Early use of HRT among APOE4 carriers was associated with larger right and left hippocampal volume (P = .035 and P = .028, respectively) – an association not found in non-APOE4 carriers. The association was also not significant when participants were not stratified by APOE genotype.
“The key important point here is the timing, or the ‘critical window,’ when HRT can be of most benefit,” Dr. Saleh said. “This is most beneficial when introduced early, before the neuropathology becomes irreversible.”
Study limitations include its cross-sectional design, which precludes the establishment of a causal relationship, and the fact that information regarding the type and dose of estrogen was not available for all participants.
HRT is not without risk, Dr. Saleh noted. She recommended that clinicians “carry out various screening tests to make sure that a woman is eligible for HRT and not at risk of hypercoagulability, for instance.”
Risk-benefit ratio
In a comment, Howard Fillit, MD, cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, called the study “exactly the kind of work that needs to be done.”
Dr. Fillit, who was not involved with the current research, is a clinical professor of geriatric medicine, palliative care medicine, and neuroscience at Mount Sinai Hospital, New York.
He compared the process with that of osteoporosis. “We know that if women are treated [with HRT] at the time of the menopause, you can prevent the rapid bone loss that occurs with rapid estrogen loss. But if you wait 5, 10 years out, once the bone loss has occurred, the HRT doesn’t really have any impact on osteoporosis risk because the horse is already out of the barn,” he said.
Although HRT carries risks, “they can clearly be managed; and if it’s proven that estrogen or hormone replacement around the time of the menopause can be protective [against AD], the risk-benefit ratio of HRT could be in favor of treatment,” Dr. Fillit added.
The study was conducted as part of the Medical Research Council NuBrain Consortium. The investigators and Dr. Fillit reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
new research suggests.
Results from a cohort study of almost 1,200 women showed that use of HRT was associated with higher delayed memory scores and larger entorhinal and hippocampal brain volumes – areas that are affected early by Alzheimer’s disease (AD) pathology.
HRT was also found to be most effective, as seen by larger hippocampal volume, when introduced during early perimenopause.
“Clinicians are very much aware of the susceptibility of women to cognitive disturbances during menopause,” lead author Rasha Saleh, MD, senior research associate, University of East Anglia (England), said in an interview.
“Identifying the at-risk APOE4 women and early HRT introduction can be of benefit. Confirming our findings in a clinical trial would be the next step forward,” Dr. Saleh said.
The findings were published online in Alzheimer’s Research and Therapy.
Personalized approaches
Dr. Saleh noted that estrogen receptors are localized in various areas of the brain, including cognition-related areas. Estrogen regulates such things as neuroinflammatory status, glucose utilization, and lipid metabolism.
“The decline of estrogen during menopause can lead to disturbance in these functions, which can accelerate AD-related pathology,” she said.
HRT during the menopausal transition and afterward is “being considered as a strategy to mitigate cognitive decline,” the investigators wrote. Early observational studies have suggested that oral estrogen “may be protective against dementia,” but results of clinical trials have been inconsistent, and some have even shown “harmful effects.”
The current researchers were “interested in the personalized approaches in the prevention of AD,” Dr. Saleh said. Preclinical and pilot data from her group have shown that women with APOE4 have “better cognitive test scores with nutritional and hormonal interventions.”
This led Dr. Saleh to hypothesize that HRT would be of more cognitive benefit for those with versus without APOE4, particularly when introduced early during the menopausal transition.
To investigate this hypothesis, the researchers analyzed baseline data from participants in the European Prevention of Alzheimer’s Dementia (EPAD) cohort. This project was initiated in 2015 with the aim of developing longitudinal models over the entire course of AD prior to dementia clinical diagnosis.
Participants were recruited from 10 European countries. All were required to be at least 50 years old, to have not been diagnosed with dementia at baseline, and to have no medical or psychiatric illness that could potentially exclude them from further research.
The current study included 1,178 women (mean age, 65.1 years), who were divided by genotype into non-APOE4 and APOE4 groups. HRT treatment for current or previous users included estrogen alone or estrogen plus progestogens via oral or transdermal administration routes, and at different doses.
The four tests used to assess cognition were the Mini-Mental State Examination dot counting to evaluate verbal working memory, the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total score, the Four Mountain Test, and the supermarket trolley virtual reality test.
Brain MRI data were collected. The researchers focused on the medial temporal lobe as the “main brain region regulating cognition and memory processing.” This lobe includes the hippocampus, the parahippocampus, the entorhinal cortex, and the amygdala.
‘Critical window’
The researchers found a “trend” toward an APOE-HRT interaction (P-interaction = .097) for the total RBANS score. In particular, it was significant for the RBANS delayed memory index, where scores were consistently higher for women with APOE4 who had received HRT, compared with all other groups (P-interaction = .009).
Within-genotype group comparisons showed that HRT users had a higher RBANS total scale score and delayed memory index (P = .045 and P = .002, respectively), but only among APOE4 carriers. Effect size analyses showed a large effect of HRT use on the Four Mountain Test score and the supermarket trolley virtual reality test score (Cohen’s d = 0.988 and 1.2, respectively).
“This large effect was found only in APOE4 carriers,” the investigators noted.
Similarly, a moderate to large effect of HRT on the left entorhinal volume was observed in APOE4 carriers (Cohen’s d = 0.63).
In members of the APOE4 group who received HRT, the left entorhinal and left and right amygdala volumes were larger, compared with both no-APOE4 and non-HRT users (P-interaction = .002, .003, and .005, respectively). Similar trends were observed for the right entorhinal volume (P = .074).
In addition, among HRT users, the left entorhinal volume was larger (P = .03); the right and left anterior cingulate gyrus volumes were smaller (P = .003 and .062, respectively); and the left superior frontal gyrus volume was larger (P = .009) in comparison with women who did not receive HRT, independently of their APOE genotype.
Early use of HRT among APOE4 carriers was associated with larger right and left hippocampal volume (P = .035 and P = .028, respectively) – an association not found in non-APOE4 carriers. The association was also not significant when participants were not stratified by APOE genotype.
“The key important point here is the timing, or the ‘critical window,’ when HRT can be of most benefit,” Dr. Saleh said. “This is most beneficial when introduced early, before the neuropathology becomes irreversible.”
Study limitations include its cross-sectional design, which precludes the establishment of a causal relationship, and the fact that information regarding the type and dose of estrogen was not available for all participants.
HRT is not without risk, Dr. Saleh noted. She recommended that clinicians “carry out various screening tests to make sure that a woman is eligible for HRT and not at risk of hypercoagulability, for instance.”
Risk-benefit ratio
In a comment, Howard Fillit, MD, cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, called the study “exactly the kind of work that needs to be done.”
Dr. Fillit, who was not involved with the current research, is a clinical professor of geriatric medicine, palliative care medicine, and neuroscience at Mount Sinai Hospital, New York.
He compared the process with that of osteoporosis. “We know that if women are treated [with HRT] at the time of the menopause, you can prevent the rapid bone loss that occurs with rapid estrogen loss. But if you wait 5, 10 years out, once the bone loss has occurred, the HRT doesn’t really have any impact on osteoporosis risk because the horse is already out of the barn,” he said.
Although HRT carries risks, “they can clearly be managed; and if it’s proven that estrogen or hormone replacement around the time of the menopause can be protective [against AD], the risk-benefit ratio of HRT could be in favor of treatment,” Dr. Fillit added.
The study was conducted as part of the Medical Research Council NuBrain Consortium. The investigators and Dr. Fillit reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ALZHEIMER’S RESEARCH AND THERAPY
Does obesity blunt effects of vitamin D supplementation?
compared with normal-weight individuals in a new analysis of a randomized trial.
“There seems to be something different happening with vitamin D metabolism at higher body weights, and this study may help explain diminished outcomes of supplementation for individuals with an elevated body mass index (BMI),” said first author Deirdre K. Tobias, ScD, an associate epidemiologist at Brigham and Women’s Hospital’s division of preventive medicine in Boston. She made the comments in a press statement issued with the study, published online in JAMA Network Open.
The findings are from a post hoc analysis of the large-scale Vitamin D and Omega-3 Trial (VITAL), which overall, showed no benefits among those randomized to 5 years of vitamin D supplementation (2,000 IU/day) versus placebo in terms of the primary endpoints of cancer or major cardiovascular disease outcomes.
However, prespecified secondary analyses according to body weight showed that those of normal weight (body mass index < 25.0 kg/m2) did have significant benefits from supplementation versus placebo in terms of cancer incidence (24% lower), cancer mortality (42% lower), and autoimmune disease (22% lower), while no corresponding benefits were observed among those who were overweight or had obesity.
The new analysis adds important context to the trial’s overall findings, noted Katherine N. Bachmann, MD, in an accompanying editorial.
“Thanks to its very large sample size and detailed biomarker analyses, the current study is able to provide novel evidence that responses to vitamin D supplementation may be attenuated in individuals with overweight and obesity, and that this may contribute to the differential outcomes by BMI noted in the original VITAL,” she wrote.
“Further studies are warranted to determine the optimal dose or circulating vitamin D level for individuals with obesity for nonskeletal health-related outcomes,” added Dr. Bachmann, division of diabetes, endocrinology, and metabolism at Vanderbilt University Medical Center, Nashville, Tenn.
New analysis examined vitamin D and biomarkers at baseline and 2 years
To take a closer look at the specific changes in vitamin D serum and biomarker levels between the different body-weight groups, Dr. Tobias and colleagues evaluated data from 16,515 participants in the trial (of the 25,000 originally included in VITAL) and looked at changes in key vitamin D serum levels and biomarkers at baseline and follow-up.
Consistent with common observations of lower vitamin D levels with obesity, participants in the higher BMI categories had incrementally lower mean levels of serum total 25-hydroxyvitamin D (25-OHD) prior to randomization, with levels ranging from 32.3 ng/mL for normal weight individuals to 28.0 ng/mL for those with obesity class II (P < .001 for a linear trend).
Baseline levels of other vitamin D biomarkers were also lower with higher BMI, including total 25-OHD 3, free vitamin D (FVD), and bioavailable vitamin D (BioD).
Among 2,742 participants with repeated blood collections at year 2, significant mean increases were observed overall at the end of the study period in serum 25-OHD levels (11.9 ng/mL) among those randomized to vitamin D supplementation, compared with little change in the placebo group (–0.7 ng/mL).
There were also significant increases, overall, in mean total 25-OHD, 25-OHD3, FVD, and BioD levels at 2 years among those receiving supplementation, with little or no change in the placebo group.
When stratified by BMI level, however, the magnitude of increase was lower among those with higher baseline BMI (all treatment effect interactions P < .001). For instance, the mean increases in total 25-OHD level at 2 years for supplementation versus placebo were 13.5 ng/mL for those with a BMI less than 25.0 versus only 10.0 ng/mL for those with a BMI of at least 35.0.
Importantly, even after controlling for baseline vitamin D status of sufficiency or insufficiency, BMI was still significantly associated with changes seen with supplementation.
“It was surprising that, even in the context of low vitamin D levels, those with higher BMI still had a blunted response to supplementation, suggesting the interaction between supplementation and BMI with health outcomes is not simply due to higher prevalence of deficiency,” Dr. Tobias said in an interview. “It really does seem that, even with insufficient or low levels at baseline, those with higher BMI are not able to catch up to sufficient levels as well as those with normal BMI.”
Mechanisms?
Among leading theories as to why higher BMI would be associated with lower serum vitamin D levels and a lower response to supplementation is that because vitamin D is a fat-soluble vitamin, the increased adiposity and fat storage capacity with higher BMI results in greater removal of the vitamin from circulation.
“Our results are largely consistent with this hypothesis,” the authors noted.
They added that weight-loss studies, including those involving bariatric surgery, have further shown greater increases in serum 25-OHD or circulating vitamin D levels after weight loss compared with baseline.
Other theories suggest that obesity-induced hepatic dysfunction can contribute to impaired vitamin D metabolism.
Without a clear understanding of the exact mechanisms, the potential for addressing the lower vitamin D levels with, for instance, higher doses of supplementation among those with obesity, also remains unclear, Dr. Tobias noted.
“I think once there’s more clarity on what the mechanism is, then it would make sense to consider what doses could be necessary to achieve the internal levels desired,” she said.
The VITAL study received funding from a grant from the National Center for Complementary and Integrative Health and other sources.
A version of this article first appeared on Medscape.com.
compared with normal-weight individuals in a new analysis of a randomized trial.
“There seems to be something different happening with vitamin D metabolism at higher body weights, and this study may help explain diminished outcomes of supplementation for individuals with an elevated body mass index (BMI),” said first author Deirdre K. Tobias, ScD, an associate epidemiologist at Brigham and Women’s Hospital’s division of preventive medicine in Boston. She made the comments in a press statement issued with the study, published online in JAMA Network Open.
The findings are from a post hoc analysis of the large-scale Vitamin D and Omega-3 Trial (VITAL), which overall, showed no benefits among those randomized to 5 years of vitamin D supplementation (2,000 IU/day) versus placebo in terms of the primary endpoints of cancer or major cardiovascular disease outcomes.
However, prespecified secondary analyses according to body weight showed that those of normal weight (body mass index < 25.0 kg/m2) did have significant benefits from supplementation versus placebo in terms of cancer incidence (24% lower), cancer mortality (42% lower), and autoimmune disease (22% lower), while no corresponding benefits were observed among those who were overweight or had obesity.
The new analysis adds important context to the trial’s overall findings, noted Katherine N. Bachmann, MD, in an accompanying editorial.
“Thanks to its very large sample size and detailed biomarker analyses, the current study is able to provide novel evidence that responses to vitamin D supplementation may be attenuated in individuals with overweight and obesity, and that this may contribute to the differential outcomes by BMI noted in the original VITAL,” she wrote.
“Further studies are warranted to determine the optimal dose or circulating vitamin D level for individuals with obesity for nonskeletal health-related outcomes,” added Dr. Bachmann, division of diabetes, endocrinology, and metabolism at Vanderbilt University Medical Center, Nashville, Tenn.
New analysis examined vitamin D and biomarkers at baseline and 2 years
To take a closer look at the specific changes in vitamin D serum and biomarker levels between the different body-weight groups, Dr. Tobias and colleagues evaluated data from 16,515 participants in the trial (of the 25,000 originally included in VITAL) and looked at changes in key vitamin D serum levels and biomarkers at baseline and follow-up.
Consistent with common observations of lower vitamin D levels with obesity, participants in the higher BMI categories had incrementally lower mean levels of serum total 25-hydroxyvitamin D (25-OHD) prior to randomization, with levels ranging from 32.3 ng/mL for normal weight individuals to 28.0 ng/mL for those with obesity class II (P < .001 for a linear trend).
Baseline levels of other vitamin D biomarkers were also lower with higher BMI, including total 25-OHD 3, free vitamin D (FVD), and bioavailable vitamin D (BioD).
Among 2,742 participants with repeated blood collections at year 2, significant mean increases were observed overall at the end of the study period in serum 25-OHD levels (11.9 ng/mL) among those randomized to vitamin D supplementation, compared with little change in the placebo group (–0.7 ng/mL).
There were also significant increases, overall, in mean total 25-OHD, 25-OHD3, FVD, and BioD levels at 2 years among those receiving supplementation, with little or no change in the placebo group.
When stratified by BMI level, however, the magnitude of increase was lower among those with higher baseline BMI (all treatment effect interactions P < .001). For instance, the mean increases in total 25-OHD level at 2 years for supplementation versus placebo were 13.5 ng/mL for those with a BMI less than 25.0 versus only 10.0 ng/mL for those with a BMI of at least 35.0.
Importantly, even after controlling for baseline vitamin D status of sufficiency or insufficiency, BMI was still significantly associated with changes seen with supplementation.
“It was surprising that, even in the context of low vitamin D levels, those with higher BMI still had a blunted response to supplementation, suggesting the interaction between supplementation and BMI with health outcomes is not simply due to higher prevalence of deficiency,” Dr. Tobias said in an interview. “It really does seem that, even with insufficient or low levels at baseline, those with higher BMI are not able to catch up to sufficient levels as well as those with normal BMI.”
Mechanisms?
Among leading theories as to why higher BMI would be associated with lower serum vitamin D levels and a lower response to supplementation is that because vitamin D is a fat-soluble vitamin, the increased adiposity and fat storage capacity with higher BMI results in greater removal of the vitamin from circulation.
“Our results are largely consistent with this hypothesis,” the authors noted.
They added that weight-loss studies, including those involving bariatric surgery, have further shown greater increases in serum 25-OHD or circulating vitamin D levels after weight loss compared with baseline.
Other theories suggest that obesity-induced hepatic dysfunction can contribute to impaired vitamin D metabolism.
Without a clear understanding of the exact mechanisms, the potential for addressing the lower vitamin D levels with, for instance, higher doses of supplementation among those with obesity, also remains unclear, Dr. Tobias noted.
“I think once there’s more clarity on what the mechanism is, then it would make sense to consider what doses could be necessary to achieve the internal levels desired,” she said.
The VITAL study received funding from a grant from the National Center for Complementary and Integrative Health and other sources.
A version of this article first appeared on Medscape.com.
compared with normal-weight individuals in a new analysis of a randomized trial.
“There seems to be something different happening with vitamin D metabolism at higher body weights, and this study may help explain diminished outcomes of supplementation for individuals with an elevated body mass index (BMI),” said first author Deirdre K. Tobias, ScD, an associate epidemiologist at Brigham and Women’s Hospital’s division of preventive medicine in Boston. She made the comments in a press statement issued with the study, published online in JAMA Network Open.
The findings are from a post hoc analysis of the large-scale Vitamin D and Omega-3 Trial (VITAL), which overall, showed no benefits among those randomized to 5 years of vitamin D supplementation (2,000 IU/day) versus placebo in terms of the primary endpoints of cancer or major cardiovascular disease outcomes.
However, prespecified secondary analyses according to body weight showed that those of normal weight (body mass index < 25.0 kg/m2) did have significant benefits from supplementation versus placebo in terms of cancer incidence (24% lower), cancer mortality (42% lower), and autoimmune disease (22% lower), while no corresponding benefits were observed among those who were overweight or had obesity.
The new analysis adds important context to the trial’s overall findings, noted Katherine N. Bachmann, MD, in an accompanying editorial.
“Thanks to its very large sample size and detailed biomarker analyses, the current study is able to provide novel evidence that responses to vitamin D supplementation may be attenuated in individuals with overweight and obesity, and that this may contribute to the differential outcomes by BMI noted in the original VITAL,” she wrote.
“Further studies are warranted to determine the optimal dose or circulating vitamin D level for individuals with obesity for nonskeletal health-related outcomes,” added Dr. Bachmann, division of diabetes, endocrinology, and metabolism at Vanderbilt University Medical Center, Nashville, Tenn.
New analysis examined vitamin D and biomarkers at baseline and 2 years
To take a closer look at the specific changes in vitamin D serum and biomarker levels between the different body-weight groups, Dr. Tobias and colleagues evaluated data from 16,515 participants in the trial (of the 25,000 originally included in VITAL) and looked at changes in key vitamin D serum levels and biomarkers at baseline and follow-up.
Consistent with common observations of lower vitamin D levels with obesity, participants in the higher BMI categories had incrementally lower mean levels of serum total 25-hydroxyvitamin D (25-OHD) prior to randomization, with levels ranging from 32.3 ng/mL for normal weight individuals to 28.0 ng/mL for those with obesity class II (P < .001 for a linear trend).
Baseline levels of other vitamin D biomarkers were also lower with higher BMI, including total 25-OHD 3, free vitamin D (FVD), and bioavailable vitamin D (BioD).
Among 2,742 participants with repeated blood collections at year 2, significant mean increases were observed overall at the end of the study period in serum 25-OHD levels (11.9 ng/mL) among those randomized to vitamin D supplementation, compared with little change in the placebo group (–0.7 ng/mL).
There were also significant increases, overall, in mean total 25-OHD, 25-OHD3, FVD, and BioD levels at 2 years among those receiving supplementation, with little or no change in the placebo group.
When stratified by BMI level, however, the magnitude of increase was lower among those with higher baseline BMI (all treatment effect interactions P < .001). For instance, the mean increases in total 25-OHD level at 2 years for supplementation versus placebo were 13.5 ng/mL for those with a BMI less than 25.0 versus only 10.0 ng/mL for those with a BMI of at least 35.0.
Importantly, even after controlling for baseline vitamin D status of sufficiency or insufficiency, BMI was still significantly associated with changes seen with supplementation.
“It was surprising that, even in the context of low vitamin D levels, those with higher BMI still had a blunted response to supplementation, suggesting the interaction between supplementation and BMI with health outcomes is not simply due to higher prevalence of deficiency,” Dr. Tobias said in an interview. “It really does seem that, even with insufficient or low levels at baseline, those with higher BMI are not able to catch up to sufficient levels as well as those with normal BMI.”
Mechanisms?
Among leading theories as to why higher BMI would be associated with lower serum vitamin D levels and a lower response to supplementation is that because vitamin D is a fat-soluble vitamin, the increased adiposity and fat storage capacity with higher BMI results in greater removal of the vitamin from circulation.
“Our results are largely consistent with this hypothesis,” the authors noted.
They added that weight-loss studies, including those involving bariatric surgery, have further shown greater increases in serum 25-OHD or circulating vitamin D levels after weight loss compared with baseline.
Other theories suggest that obesity-induced hepatic dysfunction can contribute to impaired vitamin D metabolism.
Without a clear understanding of the exact mechanisms, the potential for addressing the lower vitamin D levels with, for instance, higher doses of supplementation among those with obesity, also remains unclear, Dr. Tobias noted.
“I think once there’s more clarity on what the mechanism is, then it would make sense to consider what doses could be necessary to achieve the internal levels desired,” she said.
The VITAL study received funding from a grant from the National Center for Complementary and Integrative Health and other sources.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
A toddler presents with a dark line on a fingernail
Given the over 1-year history of an unchanging longitudinal band of pigment without extension to the proximal or lateral nailfolds or any other nail findings, the most likely diagnosis is benign longitudinal melanonychia.
Longitudinal melanonychia, also known as melanonychia striata, describes a brown to black streak of pigment extending from the nail matrix to the free edge of the nail.1,2
This disorder can occur secondary to a wide variety of benign and pathologic causes including lentigines, nevi, melanoma, chronic trauma, inflammatory skin diseases, systemic diseases, iatrogenic causes, and genetic syndromes.3 In melanocytic causes of longitudinal melanonychia, either melanocytic activation or hyperplasia drive pigmentary development leading to the brown to black band seen in the nail.4 Benign causes of longitudinal melanonychia include benign melanocyte activation, lentigo, and benign nevus.1
What’s the differential diagnosis?
The differential diagnosis for longitudinal melanonychia can include a wide variety of local and systemic causes. For our discussion, we will limit our differential to other locally involved disorders of the nail including subungual melanoma, subungual hematoma, onychomycosis, and glomus tumor.
Subungual melanoma is a rare subtype of acral lentiginous melanoma that most often presents as longitudinal melanonychia. Subungual melanoma is more common in those aged 50-70 years, individuals with personal or family history of melanoma or dysplastic nevus syndrome, and persons with African American, Native American, and Asian descent. Longitudinal melanonychia features that can be concerning for subungual melanoma include the presence of multiple colors, width greater than or equal to 3 mm, blurry borders, rapid increase in size, and extension to the proximal or lateral nailfolds (Hutchinson’s sign). Biopsy is required to make the diagnosis of subungual melanoma but is not necessary for melanonychia without atypical features.
Treatment of subungual melanoma depends on disease stage and can range from wide local excision of the nail apparatus to amputation of the affected digit and management with a medical oncologist. Given the absence of concerning neoplastic findings or personal or family history of melanoma, subungual melanoma is unlikely in this patient.
Subungual hematoma is an accumulation of blood underneath the nail plate that is typically the result of acute or chronic trauma to the distal phalanx. It can present as purple, red, pink, brown, or black discoloration under the nail plate and is most commonly found on the first toe. With acute trauma, pain is usually present upon initial injury. Subungual hematomas typically resolve on their own with normal nail growth. The absence of a history of trauma or pain, and the linear appearance of the lesion in our patient are inconsistent with a subungual hematoma.
Onychomycosis is a fungal infection of the nail caused by dermatophytes, nondermatophytes, or yeasts. It may present with longitudinal melanonychia; however, it more often presents with other nail abnormalities such as nail thickening, yellow discoloration, onycholysis, splitting, subungual hyperkeratosis, and nail plate destruction, which are not present in this patient. Furthermore, onychomycosis is more common in adults than children. Diagnosis is usually made with potassium hydroxide (KOH) preparations, histopathologic examination of nail clippings with a periodic acid-Schiff stain, fungal culture, or PCR.
Glomus tumor is a rare, benign neoplasm originating from cells of the glomus body. It is often found in the subungual region, in addition to other areas rich in glomus bodies such as the fingertips, palms, wrists, and forearms. Subungual glomus tumors present as a red, purple, or blueish lesions under the nail plate. Distal notching or an overlying longitudinal fissure may be present. Subungual glomus tumors are typically associated with pinpoint tenderness, paroxysmal pain, and cold sensitivity, features that are not present in our patient. The history and examination of our patient are much more consistent with benign longitudinal melanonychia.
It appears that melanoma associated with longitudinal melanonychia is very rare in children. According to one review published in 2020, only 12 cases of pediatric subungual melanoma have been reported.5 Recent series have observed longitudinal melanonychia in large sets of children, with findings that demonstrate that the vast majority of longitudinal melanonychia either stops progressing or regresses. These investigations therefore recommend serial observation of longitudinal melanonychia except in rare circumstances.6,7
Given the lack of troubling findings or concerning history, our patient was managed with observation. On follow-up 6 months later, he was found to have no change in his nail pigmentation.
Dr. Haft is an inflammatory skin disease fellow in the division of pediatric and adolescent dermatology; Ms. Sui is a research associate in the department of dermatology, division of pediatric and adolescent dermatology; and Dr. Eichenfield is vice chair of the department of dermatology and professor of dermatology and pediatrics, all at the University of California and Rady Children’s Hospital, San Diego. They have no relevant disclosures.
References
1. Mannava KA et al. Hand Surg. 2013;18(1):133-9.
2. Leung AKC et al. Int J Dermatol. 2019;58(11):1239-45.
3. Andre J and Lateur N. Dermatol Clin. 2006;24(3):329-39.
4. Lee DK and Lipner SR. Ann Med. 2022;54(1):694-712.
5. Smith RJ and Rubin AI. Curr Opin Pediatr. 2020;32(4):506-15. .
6. Matsui Y et al. J Am Acad Dermatol. 2022;86(4):946-8.
7. Lee JS et al. J Am Acad Dermatol. 2022;87(2):366-72.
Given the over 1-year history of an unchanging longitudinal band of pigment without extension to the proximal or lateral nailfolds or any other nail findings, the most likely diagnosis is benign longitudinal melanonychia.
Longitudinal melanonychia, also known as melanonychia striata, describes a brown to black streak of pigment extending from the nail matrix to the free edge of the nail.1,2
This disorder can occur secondary to a wide variety of benign and pathologic causes including lentigines, nevi, melanoma, chronic trauma, inflammatory skin diseases, systemic diseases, iatrogenic causes, and genetic syndromes.3 In melanocytic causes of longitudinal melanonychia, either melanocytic activation or hyperplasia drive pigmentary development leading to the brown to black band seen in the nail.4 Benign causes of longitudinal melanonychia include benign melanocyte activation, lentigo, and benign nevus.1
What’s the differential diagnosis?
The differential diagnosis for longitudinal melanonychia can include a wide variety of local and systemic causes. For our discussion, we will limit our differential to other locally involved disorders of the nail including subungual melanoma, subungual hematoma, onychomycosis, and glomus tumor.
Subungual melanoma is a rare subtype of acral lentiginous melanoma that most often presents as longitudinal melanonychia. Subungual melanoma is more common in those aged 50-70 years, individuals with personal or family history of melanoma or dysplastic nevus syndrome, and persons with African American, Native American, and Asian descent. Longitudinal melanonychia features that can be concerning for subungual melanoma include the presence of multiple colors, width greater than or equal to 3 mm, blurry borders, rapid increase in size, and extension to the proximal or lateral nailfolds (Hutchinson’s sign). Biopsy is required to make the diagnosis of subungual melanoma but is not necessary for melanonychia without atypical features.
Treatment of subungual melanoma depends on disease stage and can range from wide local excision of the nail apparatus to amputation of the affected digit and management with a medical oncologist. Given the absence of concerning neoplastic findings or personal or family history of melanoma, subungual melanoma is unlikely in this patient.
Subungual hematoma is an accumulation of blood underneath the nail plate that is typically the result of acute or chronic trauma to the distal phalanx. It can present as purple, red, pink, brown, or black discoloration under the nail plate and is most commonly found on the first toe. With acute trauma, pain is usually present upon initial injury. Subungual hematomas typically resolve on their own with normal nail growth. The absence of a history of trauma or pain, and the linear appearance of the lesion in our patient are inconsistent with a subungual hematoma.
Onychomycosis is a fungal infection of the nail caused by dermatophytes, nondermatophytes, or yeasts. It may present with longitudinal melanonychia; however, it more often presents with other nail abnormalities such as nail thickening, yellow discoloration, onycholysis, splitting, subungual hyperkeratosis, and nail plate destruction, which are not present in this patient. Furthermore, onychomycosis is more common in adults than children. Diagnosis is usually made with potassium hydroxide (KOH) preparations, histopathologic examination of nail clippings with a periodic acid-Schiff stain, fungal culture, or PCR.
Glomus tumor is a rare, benign neoplasm originating from cells of the glomus body. It is often found in the subungual region, in addition to other areas rich in glomus bodies such as the fingertips, palms, wrists, and forearms. Subungual glomus tumors present as a red, purple, or blueish lesions under the nail plate. Distal notching or an overlying longitudinal fissure may be present. Subungual glomus tumors are typically associated with pinpoint tenderness, paroxysmal pain, and cold sensitivity, features that are not present in our patient. The history and examination of our patient are much more consistent with benign longitudinal melanonychia.
It appears that melanoma associated with longitudinal melanonychia is very rare in children. According to one review published in 2020, only 12 cases of pediatric subungual melanoma have been reported.5 Recent series have observed longitudinal melanonychia in large sets of children, with findings that demonstrate that the vast majority of longitudinal melanonychia either stops progressing or regresses. These investigations therefore recommend serial observation of longitudinal melanonychia except in rare circumstances.6,7
Given the lack of troubling findings or concerning history, our patient was managed with observation. On follow-up 6 months later, he was found to have no change in his nail pigmentation.
Dr. Haft is an inflammatory skin disease fellow in the division of pediatric and adolescent dermatology; Ms. Sui is a research associate in the department of dermatology, division of pediatric and adolescent dermatology; and Dr. Eichenfield is vice chair of the department of dermatology and professor of dermatology and pediatrics, all at the University of California and Rady Children’s Hospital, San Diego. They have no relevant disclosures.
References
1. Mannava KA et al. Hand Surg. 2013;18(1):133-9.
2. Leung AKC et al. Int J Dermatol. 2019;58(11):1239-45.
3. Andre J and Lateur N. Dermatol Clin. 2006;24(3):329-39.
4. Lee DK and Lipner SR. Ann Med. 2022;54(1):694-712.
5. Smith RJ and Rubin AI. Curr Opin Pediatr. 2020;32(4):506-15. .
6. Matsui Y et al. J Am Acad Dermatol. 2022;86(4):946-8.
7. Lee JS et al. J Am Acad Dermatol. 2022;87(2):366-72.
Given the over 1-year history of an unchanging longitudinal band of pigment without extension to the proximal or lateral nailfolds or any other nail findings, the most likely diagnosis is benign longitudinal melanonychia.
Longitudinal melanonychia, also known as melanonychia striata, describes a brown to black streak of pigment extending from the nail matrix to the free edge of the nail.1,2
This disorder can occur secondary to a wide variety of benign and pathologic causes including lentigines, nevi, melanoma, chronic trauma, inflammatory skin diseases, systemic diseases, iatrogenic causes, and genetic syndromes.3 In melanocytic causes of longitudinal melanonychia, either melanocytic activation or hyperplasia drive pigmentary development leading to the brown to black band seen in the nail.4 Benign causes of longitudinal melanonychia include benign melanocyte activation, lentigo, and benign nevus.1
What’s the differential diagnosis?
The differential diagnosis for longitudinal melanonychia can include a wide variety of local and systemic causes. For our discussion, we will limit our differential to other locally involved disorders of the nail including subungual melanoma, subungual hematoma, onychomycosis, and glomus tumor.
Subungual melanoma is a rare subtype of acral lentiginous melanoma that most often presents as longitudinal melanonychia. Subungual melanoma is more common in those aged 50-70 years, individuals with personal or family history of melanoma or dysplastic nevus syndrome, and persons with African American, Native American, and Asian descent. Longitudinal melanonychia features that can be concerning for subungual melanoma include the presence of multiple colors, width greater than or equal to 3 mm, blurry borders, rapid increase in size, and extension to the proximal or lateral nailfolds (Hutchinson’s sign). Biopsy is required to make the diagnosis of subungual melanoma but is not necessary for melanonychia without atypical features.
Treatment of subungual melanoma depends on disease stage and can range from wide local excision of the nail apparatus to amputation of the affected digit and management with a medical oncologist. Given the absence of concerning neoplastic findings or personal or family history of melanoma, subungual melanoma is unlikely in this patient.
Subungual hematoma is an accumulation of blood underneath the nail plate that is typically the result of acute or chronic trauma to the distal phalanx. It can present as purple, red, pink, brown, or black discoloration under the nail plate and is most commonly found on the first toe. With acute trauma, pain is usually present upon initial injury. Subungual hematomas typically resolve on their own with normal nail growth. The absence of a history of trauma or pain, and the linear appearance of the lesion in our patient are inconsistent with a subungual hematoma.
Onychomycosis is a fungal infection of the nail caused by dermatophytes, nondermatophytes, or yeasts. It may present with longitudinal melanonychia; however, it more often presents with other nail abnormalities such as nail thickening, yellow discoloration, onycholysis, splitting, subungual hyperkeratosis, and nail plate destruction, which are not present in this patient. Furthermore, onychomycosis is more common in adults than children. Diagnosis is usually made with potassium hydroxide (KOH) preparations, histopathologic examination of nail clippings with a periodic acid-Schiff stain, fungal culture, or PCR.
Glomus tumor is a rare, benign neoplasm originating from cells of the glomus body. It is often found in the subungual region, in addition to other areas rich in glomus bodies such as the fingertips, palms, wrists, and forearms. Subungual glomus tumors present as a red, purple, or blueish lesions under the nail plate. Distal notching or an overlying longitudinal fissure may be present. Subungual glomus tumors are typically associated with pinpoint tenderness, paroxysmal pain, and cold sensitivity, features that are not present in our patient. The history and examination of our patient are much more consistent with benign longitudinal melanonychia.
It appears that melanoma associated with longitudinal melanonychia is very rare in children. According to one review published in 2020, only 12 cases of pediatric subungual melanoma have been reported.5 Recent series have observed longitudinal melanonychia in large sets of children, with findings that demonstrate that the vast majority of longitudinal melanonychia either stops progressing or regresses. These investigations therefore recommend serial observation of longitudinal melanonychia except in rare circumstances.6,7
Given the lack of troubling findings or concerning history, our patient was managed with observation. On follow-up 6 months later, he was found to have no change in his nail pigmentation.
Dr. Haft is an inflammatory skin disease fellow in the division of pediatric and adolescent dermatology; Ms. Sui is a research associate in the department of dermatology, division of pediatric and adolescent dermatology; and Dr. Eichenfield is vice chair of the department of dermatology and professor of dermatology and pediatrics, all at the University of California and Rady Children’s Hospital, San Diego. They have no relevant disclosures.
References
1. Mannava KA et al. Hand Surg. 2013;18(1):133-9.
2. Leung AKC et al. Int J Dermatol. 2019;58(11):1239-45.
3. Andre J and Lateur N. Dermatol Clin. 2006;24(3):329-39.
4. Lee DK and Lipner SR. Ann Med. 2022;54(1):694-712.
5. Smith RJ and Rubin AI. Curr Opin Pediatr. 2020;32(4):506-15. .
6. Matsui Y et al. J Am Acad Dermatol. 2022;86(4):946-8.
7. Lee JS et al. J Am Acad Dermatol. 2022;87(2):366-72.
Examination findings reveal a 2-mm brown longitudinal band on the radial aspect of the right thumbnail that does not extend into the proximal or lateral nailfolds. The rest of the skin and nail exam is unremarkable.
Possible bivalent vaccine link to strokes in people over 65
who got the shot, the Centers for Disease Control and Prevention and the Food and Drug Administration said in a joint news release.
The release did not recommend people change their vaccine practices, saying the database finding probably did not represent a “true clinical risk.” The CDC said everybody, including people over 65, should stay up to date on their COVID vaccines, including the bivalent booster.
The news release said the Vaccine Safety Datalink (VSD), “a near real-time surveillance system,” raised a safety concern about the Pfizer/BioNTech booster.
“Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-44 following vaccination,” the news release said.
Ischemic strokes are blockages of blood to the brain, often caused by blood clots.
“Although the totality of the data currently suggests that it is very unlikely that the signal in VSD (Vaccine Safety Datalink) represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal,” the release said.
No higher likelihood of strokes linked to the Pfizer bivalent vaccine had been found by Pfizer/BioNTech, the Department of Veterans Affairs, the Vaccine Adverse Event Reporting System maintained by the CDC and the FDA, or other agencies that monitor reactions of vaccines, the news release said. No safety issues about strokes have been identified with the Moderna bivalent vaccine.
CNN, citing a CDC official, reported that about 550,000 seniors who got Pfizer bivalent boosters were tracked by the VSD, and 130 of them had strokes within 3 weeks of getting the shot. None of those 130 people died, CNN said. The official spoke on the condition of anonymity because they weren’t authorized to share the data.
The issue will be discussed at the January meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.
In a joint statement, Pfizer and BioNTech said: “Neither Pfizer and BioNTech nor the CDC or FDA have observed similar findings across numerous other monitoring systems in the U.S. and globally and there is no evidence to conclude that ischemic stroke is associated with the use of the companies’ COVID-19 vaccines.”
Bivalent boosters contain two strains of vaccine – one to protect against the original COVID-19 virus and another targeting Omicron subvariants.
A version of this article first appeared on WebMD.com.
who got the shot, the Centers for Disease Control and Prevention and the Food and Drug Administration said in a joint news release.
The release did not recommend people change their vaccine practices, saying the database finding probably did not represent a “true clinical risk.” The CDC said everybody, including people over 65, should stay up to date on their COVID vaccines, including the bivalent booster.
The news release said the Vaccine Safety Datalink (VSD), “a near real-time surveillance system,” raised a safety concern about the Pfizer/BioNTech booster.
“Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-44 following vaccination,” the news release said.
Ischemic strokes are blockages of blood to the brain, often caused by blood clots.
“Although the totality of the data currently suggests that it is very unlikely that the signal in VSD (Vaccine Safety Datalink) represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal,” the release said.
No higher likelihood of strokes linked to the Pfizer bivalent vaccine had been found by Pfizer/BioNTech, the Department of Veterans Affairs, the Vaccine Adverse Event Reporting System maintained by the CDC and the FDA, or other agencies that monitor reactions of vaccines, the news release said. No safety issues about strokes have been identified with the Moderna bivalent vaccine.
CNN, citing a CDC official, reported that about 550,000 seniors who got Pfizer bivalent boosters were tracked by the VSD, and 130 of them had strokes within 3 weeks of getting the shot. None of those 130 people died, CNN said. The official spoke on the condition of anonymity because they weren’t authorized to share the data.
The issue will be discussed at the January meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.
In a joint statement, Pfizer and BioNTech said: “Neither Pfizer and BioNTech nor the CDC or FDA have observed similar findings across numerous other monitoring systems in the U.S. and globally and there is no evidence to conclude that ischemic stroke is associated with the use of the companies’ COVID-19 vaccines.”
Bivalent boosters contain two strains of vaccine – one to protect against the original COVID-19 virus and another targeting Omicron subvariants.
A version of this article first appeared on WebMD.com.
who got the shot, the Centers for Disease Control and Prevention and the Food and Drug Administration said in a joint news release.
The release did not recommend people change their vaccine practices, saying the database finding probably did not represent a “true clinical risk.” The CDC said everybody, including people over 65, should stay up to date on their COVID vaccines, including the bivalent booster.
The news release said the Vaccine Safety Datalink (VSD), “a near real-time surveillance system,” raised a safety concern about the Pfizer/BioNTech booster.
“Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-44 following vaccination,” the news release said.
Ischemic strokes are blockages of blood to the brain, often caused by blood clots.
“Although the totality of the data currently suggests that it is very unlikely that the signal in VSD (Vaccine Safety Datalink) represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal,” the release said.
No higher likelihood of strokes linked to the Pfizer bivalent vaccine had been found by Pfizer/BioNTech, the Department of Veterans Affairs, the Vaccine Adverse Event Reporting System maintained by the CDC and the FDA, or other agencies that monitor reactions of vaccines, the news release said. No safety issues about strokes have been identified with the Moderna bivalent vaccine.
CNN, citing a CDC official, reported that about 550,000 seniors who got Pfizer bivalent boosters were tracked by the VSD, and 130 of them had strokes within 3 weeks of getting the shot. None of those 130 people died, CNN said. The official spoke on the condition of anonymity because they weren’t authorized to share the data.
The issue will be discussed at the January meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.
In a joint statement, Pfizer and BioNTech said: “Neither Pfizer and BioNTech nor the CDC or FDA have observed similar findings across numerous other monitoring systems in the U.S. and globally and there is no evidence to conclude that ischemic stroke is associated with the use of the companies’ COVID-19 vaccines.”
Bivalent boosters contain two strains of vaccine – one to protect against the original COVID-19 virus and another targeting Omicron subvariants.
A version of this article first appeared on WebMD.com.
Updated celiac disease guideline addresses common clinical questions
The American College of Gastroenterology issued updated guidelines for celiac disease diagnosis, management, and screening that incorporates research conducted since the last update in 2013.
The guidelines offer evidence-based recommendations for common clinical questions on topics that include nonbiopsy diagnosis, gluten-free oats, probiotic use, and gluten-detection devices. They also point to areas for ongoing research.
“The main message of the guideline is all about quality of care,” Alberto Rubio-Tapia, MD, a gastroenterologist at the Cleveland Clinic, said in an interview.
“A precise celiac disease diagnosis is just the beginning of the role of the gastroenterologist,” he said. “But most importantly, we need to take care of our patients’ needs with good goal-directed follow-up using a multidisciplinary approach, with experienced dietitians playing an important role.”
The update was published in the American Journal of Gastroenterology.
Diagnosis recommendations
The ACG assembled a team of celiac disease experts and expert guideline methodologists to develop an update with high-quality evidence, Dr. Rubio-Tapia said. The authors made recommendations and suggestions for future research regarding eight questions concerning diagnosis, disease management, and screening.
For diagnosis, the guidelines recommend esophagogastroduodenoscopy (EGD) with multiple duodenal biopsies – one or two from the bulb and four from the distal duodenum – for confirmation in children and adults with suspicion of celiac disease. EGD and duodenal biopsies can also be useful for the differential diagnosis of other malabsorptive disorders or enteropathies, the authors wrote.
For children, a nonbiopsy option may be considered to be reliable for diagnosis. This option includes a combination of high-level tissue transglutaminase (TTG) IgA – at greater than 10 times the upper limit of normal – and a positive endomysial antibody finding in a second blood sample. The same criteria may be considered after the fact for symptomatic adults who are unwilling or unable to undergo upper GI endoscopy.
For children younger than 2 years, the TTG-IgA is the preferred test for those who are not IgA deficient. For children with IgA deficiency, testing should be performed using IgG-based antibodies.
Disease management guidance
After diagnosis, intestinal healing should be the endpoint for a gluten-free diet, the guidelines recommended. Clinicians and patients should discuss individualized goals of the gluten-free diet beyond clinical and serologic remission.
The standard of care for assessing patients’ diet adherence is an interview with a dietician who has expertise in gluten-free diets, the recommendations stated. Subsequent visits should be encouraged as needed to reinforce adherence.
During disease management, upper endoscopy with intestinal biopsies can be helpful for monitoring cases in which there is a lack of clinical response or in which symptoms relapse despite a gluten-free diet, the authors noted.
In addition, after a shared decision-making conversation between the patient and provider, a follow-up biopsy could be considered for assessment of mucosal healing in adults who don’t have symptoms 2 years after starting a gluten-free diet, they wrote.
“Although most patients do well on a gluten-free diet, it’s a heavy burden of care and an important issue that impacts patients,” Joseph Murray, MD, a gastroenterologist at the Mayo Clinic in Rochester, Minn., said in an interview.
Dr. Murray, who wasn’t involved with this guideline update, contributed to the 2013 guidelines and the 2019 American Gastroenterological Association practice update on diagnosing and monitoring celiac disease. He agreed with many of the recommendations in this update.
“The goal of achieving healing is a good goal to reach. We do that routinely in my practice,” he said. “The older the patient, perhaps the more important it is to discuss, including the risk for complications. There’s a nuance involved with shared decision-making.”
Nutrition advice
The guidelines recommended against routine use of gluten-detection devices for food or biospecimens for patients with celiac disease. Although multiple devices have become commercially available in recent years, they are not regulated by the Food and Drug Administration and have sensitivity problems that can lead to false positive and false negative results, the authors noted. There’s also a lack of evidence that the devices enhance diet adherence or quality of life.
The evidence is insufficient to recommend for or against the use of probiotics for the treatment of celiac disease, the recommendations stated. Although dysbiosis is a feature of celiac disease, its role in disease pathogenesis and symptomatology is uncertain, the authors wrote.
Probiotics may help with functional disorders, such as irritable bowel syndrome, but because probiotics are marketed as supplements and regulations are lax, some products may contain detectable gluten despite being labeled gluten free, they added.
On the other hand, the authors recommended gluten-free oats as part of a gluten-free diet. Oat consumption appears to be safe for most patients with celiac disease, but it may be immunogenic in a subset of patients, depending on the products or quantity consumed. Given the small risk for an immune reaction to the oat protein avenin, monitoring for oat tolerance through symptoms and serology should be conducted, although the intervals for monitoring remain unknown.
Vaccination and screening
The guidelines also support vaccination against pneumococcal disease, since adults with celiac disease are at significantly increased risk of infection and complications. Vaccination is widely recommended for people aged 65 and older, for smokers aged 19-64, and for adults with underlying conditions that place them at higher risk, the authors noted.
Overall, the guidelines recommended case findings to increase detection of celiac disease in clinical practice but recommend against mass screening in the community. Patients with symptoms for whom there is lab evidence of malabsorption should be tested, as well as those for whom celiac disease could be a treatable cause of symptoms, the authors wrote. Those with a first-degree family member who has a confirmed diagnosis should also be tested if they have possible symptoms, and asymptomatic relatives should consider testing as well.
The updated guidelines include changes that are important for patients and patient care, and they emphasize the need for continued research on key questions, Isabel Hujoel, MD, a gastroenterologist at the University of Washington Medical Center, Seattle, told this news organization.
“In particular, the discussion on the lack of evidence behind gluten-detection devices and probiotic use in celiac disease addresses conversations that come up frequently in clinic,” said Dr. Hujoel, who wasn’t involved with the update. “The guidelines also include a new addition below each recommendation where future research questions are raised. Many of these questions address gaps in our understanding on celiac disease, such as the possibility of a nonbiopsy diagnosis in adults, which will potentially dramatically impact patient care if addressed.”
The update received no funding. The authors, Dr. Murray, and Dr. Hujoel have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The American College of Gastroenterology issued updated guidelines for celiac disease diagnosis, management, and screening that incorporates research conducted since the last update in 2013.
The guidelines offer evidence-based recommendations for common clinical questions on topics that include nonbiopsy diagnosis, gluten-free oats, probiotic use, and gluten-detection devices. They also point to areas for ongoing research.
“The main message of the guideline is all about quality of care,” Alberto Rubio-Tapia, MD, a gastroenterologist at the Cleveland Clinic, said in an interview.
“A precise celiac disease diagnosis is just the beginning of the role of the gastroenterologist,” he said. “But most importantly, we need to take care of our patients’ needs with good goal-directed follow-up using a multidisciplinary approach, with experienced dietitians playing an important role.”
The update was published in the American Journal of Gastroenterology.
Diagnosis recommendations
The ACG assembled a team of celiac disease experts and expert guideline methodologists to develop an update with high-quality evidence, Dr. Rubio-Tapia said. The authors made recommendations and suggestions for future research regarding eight questions concerning diagnosis, disease management, and screening.
For diagnosis, the guidelines recommend esophagogastroduodenoscopy (EGD) with multiple duodenal biopsies – one or two from the bulb and four from the distal duodenum – for confirmation in children and adults with suspicion of celiac disease. EGD and duodenal biopsies can also be useful for the differential diagnosis of other malabsorptive disorders or enteropathies, the authors wrote.
For children, a nonbiopsy option may be considered to be reliable for diagnosis. This option includes a combination of high-level tissue transglutaminase (TTG) IgA – at greater than 10 times the upper limit of normal – and a positive endomysial antibody finding in a second blood sample. The same criteria may be considered after the fact for symptomatic adults who are unwilling or unable to undergo upper GI endoscopy.
For children younger than 2 years, the TTG-IgA is the preferred test for those who are not IgA deficient. For children with IgA deficiency, testing should be performed using IgG-based antibodies.
Disease management guidance
After diagnosis, intestinal healing should be the endpoint for a gluten-free diet, the guidelines recommended. Clinicians and patients should discuss individualized goals of the gluten-free diet beyond clinical and serologic remission.
The standard of care for assessing patients’ diet adherence is an interview with a dietician who has expertise in gluten-free diets, the recommendations stated. Subsequent visits should be encouraged as needed to reinforce adherence.
During disease management, upper endoscopy with intestinal biopsies can be helpful for monitoring cases in which there is a lack of clinical response or in which symptoms relapse despite a gluten-free diet, the authors noted.
In addition, after a shared decision-making conversation between the patient and provider, a follow-up biopsy could be considered for assessment of mucosal healing in adults who don’t have symptoms 2 years after starting a gluten-free diet, they wrote.
“Although most patients do well on a gluten-free diet, it’s a heavy burden of care and an important issue that impacts patients,” Joseph Murray, MD, a gastroenterologist at the Mayo Clinic in Rochester, Minn., said in an interview.
Dr. Murray, who wasn’t involved with this guideline update, contributed to the 2013 guidelines and the 2019 American Gastroenterological Association practice update on diagnosing and monitoring celiac disease. He agreed with many of the recommendations in this update.
“The goal of achieving healing is a good goal to reach. We do that routinely in my practice,” he said. “The older the patient, perhaps the more important it is to discuss, including the risk for complications. There’s a nuance involved with shared decision-making.”
Nutrition advice
The guidelines recommended against routine use of gluten-detection devices for food or biospecimens for patients with celiac disease. Although multiple devices have become commercially available in recent years, they are not regulated by the Food and Drug Administration and have sensitivity problems that can lead to false positive and false negative results, the authors noted. There’s also a lack of evidence that the devices enhance diet adherence or quality of life.
The evidence is insufficient to recommend for or against the use of probiotics for the treatment of celiac disease, the recommendations stated. Although dysbiosis is a feature of celiac disease, its role in disease pathogenesis and symptomatology is uncertain, the authors wrote.
Probiotics may help with functional disorders, such as irritable bowel syndrome, but because probiotics are marketed as supplements and regulations are lax, some products may contain detectable gluten despite being labeled gluten free, they added.
On the other hand, the authors recommended gluten-free oats as part of a gluten-free diet. Oat consumption appears to be safe for most patients with celiac disease, but it may be immunogenic in a subset of patients, depending on the products or quantity consumed. Given the small risk for an immune reaction to the oat protein avenin, monitoring for oat tolerance through symptoms and serology should be conducted, although the intervals for monitoring remain unknown.
Vaccination and screening
The guidelines also support vaccination against pneumococcal disease, since adults with celiac disease are at significantly increased risk of infection and complications. Vaccination is widely recommended for people aged 65 and older, for smokers aged 19-64, and for adults with underlying conditions that place them at higher risk, the authors noted.
Overall, the guidelines recommended case findings to increase detection of celiac disease in clinical practice but recommend against mass screening in the community. Patients with symptoms for whom there is lab evidence of malabsorption should be tested, as well as those for whom celiac disease could be a treatable cause of symptoms, the authors wrote. Those with a first-degree family member who has a confirmed diagnosis should also be tested if they have possible symptoms, and asymptomatic relatives should consider testing as well.
The updated guidelines include changes that are important for patients and patient care, and they emphasize the need for continued research on key questions, Isabel Hujoel, MD, a gastroenterologist at the University of Washington Medical Center, Seattle, told this news organization.
“In particular, the discussion on the lack of evidence behind gluten-detection devices and probiotic use in celiac disease addresses conversations that come up frequently in clinic,” said Dr. Hujoel, who wasn’t involved with the update. “The guidelines also include a new addition below each recommendation where future research questions are raised. Many of these questions address gaps in our understanding on celiac disease, such as the possibility of a nonbiopsy diagnosis in adults, which will potentially dramatically impact patient care if addressed.”
The update received no funding. The authors, Dr. Murray, and Dr. Hujoel have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The American College of Gastroenterology issued updated guidelines for celiac disease diagnosis, management, and screening that incorporates research conducted since the last update in 2013.
The guidelines offer evidence-based recommendations for common clinical questions on topics that include nonbiopsy diagnosis, gluten-free oats, probiotic use, and gluten-detection devices. They also point to areas for ongoing research.
“The main message of the guideline is all about quality of care,” Alberto Rubio-Tapia, MD, a gastroenterologist at the Cleveland Clinic, said in an interview.
“A precise celiac disease diagnosis is just the beginning of the role of the gastroenterologist,” he said. “But most importantly, we need to take care of our patients’ needs with good goal-directed follow-up using a multidisciplinary approach, with experienced dietitians playing an important role.”
The update was published in the American Journal of Gastroenterology.
Diagnosis recommendations
The ACG assembled a team of celiac disease experts and expert guideline methodologists to develop an update with high-quality evidence, Dr. Rubio-Tapia said. The authors made recommendations and suggestions for future research regarding eight questions concerning diagnosis, disease management, and screening.
For diagnosis, the guidelines recommend esophagogastroduodenoscopy (EGD) with multiple duodenal biopsies – one or two from the bulb and four from the distal duodenum – for confirmation in children and adults with suspicion of celiac disease. EGD and duodenal biopsies can also be useful for the differential diagnosis of other malabsorptive disorders or enteropathies, the authors wrote.
For children, a nonbiopsy option may be considered to be reliable for diagnosis. This option includes a combination of high-level tissue transglutaminase (TTG) IgA – at greater than 10 times the upper limit of normal – and a positive endomysial antibody finding in a second blood sample. The same criteria may be considered after the fact for symptomatic adults who are unwilling or unable to undergo upper GI endoscopy.
For children younger than 2 years, the TTG-IgA is the preferred test for those who are not IgA deficient. For children with IgA deficiency, testing should be performed using IgG-based antibodies.
Disease management guidance
After diagnosis, intestinal healing should be the endpoint for a gluten-free diet, the guidelines recommended. Clinicians and patients should discuss individualized goals of the gluten-free diet beyond clinical and serologic remission.
The standard of care for assessing patients’ diet adherence is an interview with a dietician who has expertise in gluten-free diets, the recommendations stated. Subsequent visits should be encouraged as needed to reinforce adherence.
During disease management, upper endoscopy with intestinal biopsies can be helpful for monitoring cases in which there is a lack of clinical response or in which symptoms relapse despite a gluten-free diet, the authors noted.
In addition, after a shared decision-making conversation between the patient and provider, a follow-up biopsy could be considered for assessment of mucosal healing in adults who don’t have symptoms 2 years after starting a gluten-free diet, they wrote.
“Although most patients do well on a gluten-free diet, it’s a heavy burden of care and an important issue that impacts patients,” Joseph Murray, MD, a gastroenterologist at the Mayo Clinic in Rochester, Minn., said in an interview.
Dr. Murray, who wasn’t involved with this guideline update, contributed to the 2013 guidelines and the 2019 American Gastroenterological Association practice update on diagnosing and monitoring celiac disease. He agreed with many of the recommendations in this update.
“The goal of achieving healing is a good goal to reach. We do that routinely in my practice,” he said. “The older the patient, perhaps the more important it is to discuss, including the risk for complications. There’s a nuance involved with shared decision-making.”
Nutrition advice
The guidelines recommended against routine use of gluten-detection devices for food or biospecimens for patients with celiac disease. Although multiple devices have become commercially available in recent years, they are not regulated by the Food and Drug Administration and have sensitivity problems that can lead to false positive and false negative results, the authors noted. There’s also a lack of evidence that the devices enhance diet adherence or quality of life.
The evidence is insufficient to recommend for or against the use of probiotics for the treatment of celiac disease, the recommendations stated. Although dysbiosis is a feature of celiac disease, its role in disease pathogenesis and symptomatology is uncertain, the authors wrote.
Probiotics may help with functional disorders, such as irritable bowel syndrome, but because probiotics are marketed as supplements and regulations are lax, some products may contain detectable gluten despite being labeled gluten free, they added.
On the other hand, the authors recommended gluten-free oats as part of a gluten-free diet. Oat consumption appears to be safe for most patients with celiac disease, but it may be immunogenic in a subset of patients, depending on the products or quantity consumed. Given the small risk for an immune reaction to the oat protein avenin, monitoring for oat tolerance through symptoms and serology should be conducted, although the intervals for monitoring remain unknown.
Vaccination and screening
The guidelines also support vaccination against pneumococcal disease, since adults with celiac disease are at significantly increased risk of infection and complications. Vaccination is widely recommended for people aged 65 and older, for smokers aged 19-64, and for adults with underlying conditions that place them at higher risk, the authors noted.
Overall, the guidelines recommended case findings to increase detection of celiac disease in clinical practice but recommend against mass screening in the community. Patients with symptoms for whom there is lab evidence of malabsorption should be tested, as well as those for whom celiac disease could be a treatable cause of symptoms, the authors wrote. Those with a first-degree family member who has a confirmed diagnosis should also be tested if they have possible symptoms, and asymptomatic relatives should consider testing as well.
The updated guidelines include changes that are important for patients and patient care, and they emphasize the need for continued research on key questions, Isabel Hujoel, MD, a gastroenterologist at the University of Washington Medical Center, Seattle, told this news organization.
“In particular, the discussion on the lack of evidence behind gluten-detection devices and probiotic use in celiac disease addresses conversations that come up frequently in clinic,” said Dr. Hujoel, who wasn’t involved with the update. “The guidelines also include a new addition below each recommendation where future research questions are raised. Many of these questions address gaps in our understanding on celiac disease, such as the possibility of a nonbiopsy diagnosis in adults, which will potentially dramatically impact patient care if addressed.”
The update received no funding. The authors, Dr. Murray, and Dr. Hujoel have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE AMERICAN JOURNAL OF GASTROENTEROLOGY
Oncologists may be too quick to refer patients to palliative care
I recently met Jane, a 53-year-old woman with metastatic breast cancer. She was referred to me by the breast oncology team, which routinely refers all metastatic patients to our palliative care clinic.
Clocking in at under 20 minutes, my consultation with Jane might have been one of my shortest on record. Not only had the breast oncology team already addressed Jane’s symptoms, which mainly consisted of hot flashes and joint pain attributable to treatment with an aromatase inhibitor, but they had already started planning ahead for the future of her illness. Jane had completed an advance directive and had a realistic and hopeful perspective on how her illness would progress. She understood the goal of her treatment was to “keep the cancer asleep,” as she put it, and she was very clear about her own goals: to live long enough to see her granddaughter graduate from high school in 2 years and to take a long-awaited trip to Australia later in 2023.
There wasn’t much for me to do. In fact, I daresay that Jane really did not need to see a palliative care specialist because the primary palliative care she was receiving from the breast oncology team was superb. Jane was receiving excellent symptom management from a nurse practitioner and oncologist, plus a social worker provided her with coping strategies. She was already having conversations with her primary medical team and her family about what to expect in the future and how to plan ahead for all possible outcomes.
When should a patient be referred to palliative care?
Integrating palliative care into routine oncologic care need not always require the time and skill of a palliative care team for every patient. Oncology providers can provide basic palliative care services without consulting a palliative care specialist.
For example, if a primary care doctor tried to refer every patient with hypertension to cardiology, the cardiologist would probably say that primary care should be able to handle basic hypertension management. In my experience from working in an oncology clinic for the past 9 years, I’ve found that oncology providers don’t need to refer every advanced cancer patient to our palliative care program. Most oncologists have good communication skills and are more than capable of managing symptoms for patients.
But don’t get me wrong.
Palliative care for all?
In 2010, Jennifer S. Temel MD, published a landmark study in the New England Journal of Medicine that demonstrated significant improvements in quality of life and mood in patients with metastatic lung cancer who received concurrent palliative care. After the study was published many voices inside oncology and palliative care began to advocate for a “palliative care for all” approach to patients with metastatic disease. But this is often interpreted as “specialty palliative care for all,” rather than its original intended meaning that all patients with metastatic disease receive the essential elements of palliative care (biopsychosocial symptom support and conversations about goals of care) either through their primary oncology teams or, if needed, specialty palliative care teams.
The fact is that most specialty palliative care clinics do not have the manpower to meet the needs of all patients with advanced cancers, much less all patients living with serious illness. A main goal of integrating palliative care into routine outpatient health care has always been (and in my opinion, should continue to be) to enhance the primary palliative care skills of specialists, such as oncologists and cardiologists, who care for some of our sickest patients.
This could take many forms. For one, it can be helpful to screen patients for palliative care needs. The American College of Surgeons Commission on Cancer mandates distress screening for all patients as a condition of accreditation. Distress screening using a validated tool such as the National Comprehensive Cancer Network Distress Thermometer can differentiate patients who have minimal distress and may not need much additional support beyond what is provided by their oncology team from those whose distress feels unmanageable and overwhelming.
In terms of primary palliative care symptom management, most oncology teams I work with are comfortable prescribing basic medications for pain, nausea, constipation, and anxiety. They’re also comfortable referring oncology patients for nutrition needs while undergoing chemotherapy as well as to social work and spiritual care for emotional support and counseling.
Oncology teams should continually work on communications skills. They should use “Ask, Tell, Ask” to elicit prognostic awareness, convey critical information, and assess for recall and understanding at pivotal points in the cancer journey, such as when the disease progresses or the patient’s clinical condition changes. They should practice a normalizing script they can use to introduce advance care planning to their patients in the first few visits. When I meet with a patient for the first time, I usually begin by asking if they have prepared an advanced directive. If not, I ask if they’ve thought about who will make medical decisions for them should the need arise. If the patient has documented in writing their preference for care in an emergency situation, I ask for a copy for their chart.
When should patients be referred to a specialty palliative care program?
I tell our oncology teams to involve me after they have tried to intervene, but unsuccessfully because of the patient having intractable symptoms, such as pain, or the disease is not responding to treatments. Or, because there are significant communication or health literacy barriers. Or, because there are challenging family dynamics that are impeding progress in establishing goals of care.
A physician should refer to specialty palliative care when there are multiple comorbid conditions that impact a patient’s prognosis and ability to tolerate treatments. These patients will need detailed symptom management and nuanced conversations about the delicate balance of maintaining quality of life and trying to address their malignancy while also avoiding treatments that may do more harm than good.
At the end of the day, all patients with serious illnesses deserve a palliative care approach to their care from all of their clinicians, not just from the palliative care team. By continuously honing and implementing primary palliative care skills, oncology teams can feel empowered to meet the needs of their patients themselves, strengthening their bond with their patients making truly patient-centered care much more likely.
Ms. D’Ambruoso is a hospice and palliative care nurse practitioner for UCLA Health Cancer Care, Santa Monica, Calif.
I recently met Jane, a 53-year-old woman with metastatic breast cancer. She was referred to me by the breast oncology team, which routinely refers all metastatic patients to our palliative care clinic.
Clocking in at under 20 minutes, my consultation with Jane might have been one of my shortest on record. Not only had the breast oncology team already addressed Jane’s symptoms, which mainly consisted of hot flashes and joint pain attributable to treatment with an aromatase inhibitor, but they had already started planning ahead for the future of her illness. Jane had completed an advance directive and had a realistic and hopeful perspective on how her illness would progress. She understood the goal of her treatment was to “keep the cancer asleep,” as she put it, and she was very clear about her own goals: to live long enough to see her granddaughter graduate from high school in 2 years and to take a long-awaited trip to Australia later in 2023.
There wasn’t much for me to do. In fact, I daresay that Jane really did not need to see a palliative care specialist because the primary palliative care she was receiving from the breast oncology team was superb. Jane was receiving excellent symptom management from a nurse practitioner and oncologist, plus a social worker provided her with coping strategies. She was already having conversations with her primary medical team and her family about what to expect in the future and how to plan ahead for all possible outcomes.
When should a patient be referred to palliative care?
Integrating palliative care into routine oncologic care need not always require the time and skill of a palliative care team for every patient. Oncology providers can provide basic palliative care services without consulting a palliative care specialist.
For example, if a primary care doctor tried to refer every patient with hypertension to cardiology, the cardiologist would probably say that primary care should be able to handle basic hypertension management. In my experience from working in an oncology clinic for the past 9 years, I’ve found that oncology providers don’t need to refer every advanced cancer patient to our palliative care program. Most oncologists have good communication skills and are more than capable of managing symptoms for patients.
But don’t get me wrong.
Palliative care for all?
In 2010, Jennifer S. Temel MD, published a landmark study in the New England Journal of Medicine that demonstrated significant improvements in quality of life and mood in patients with metastatic lung cancer who received concurrent palliative care. After the study was published many voices inside oncology and palliative care began to advocate for a “palliative care for all” approach to patients with metastatic disease. But this is often interpreted as “specialty palliative care for all,” rather than its original intended meaning that all patients with metastatic disease receive the essential elements of palliative care (biopsychosocial symptom support and conversations about goals of care) either through their primary oncology teams or, if needed, specialty palliative care teams.
The fact is that most specialty palliative care clinics do not have the manpower to meet the needs of all patients with advanced cancers, much less all patients living with serious illness. A main goal of integrating palliative care into routine outpatient health care has always been (and in my opinion, should continue to be) to enhance the primary palliative care skills of specialists, such as oncologists and cardiologists, who care for some of our sickest patients.
This could take many forms. For one, it can be helpful to screen patients for palliative care needs. The American College of Surgeons Commission on Cancer mandates distress screening for all patients as a condition of accreditation. Distress screening using a validated tool such as the National Comprehensive Cancer Network Distress Thermometer can differentiate patients who have minimal distress and may not need much additional support beyond what is provided by their oncology team from those whose distress feels unmanageable and overwhelming.
In terms of primary palliative care symptom management, most oncology teams I work with are comfortable prescribing basic medications for pain, nausea, constipation, and anxiety. They’re also comfortable referring oncology patients for nutrition needs while undergoing chemotherapy as well as to social work and spiritual care for emotional support and counseling.
Oncology teams should continually work on communications skills. They should use “Ask, Tell, Ask” to elicit prognostic awareness, convey critical information, and assess for recall and understanding at pivotal points in the cancer journey, such as when the disease progresses or the patient’s clinical condition changes. They should practice a normalizing script they can use to introduce advance care planning to their patients in the first few visits. When I meet with a patient for the first time, I usually begin by asking if they have prepared an advanced directive. If not, I ask if they’ve thought about who will make medical decisions for them should the need arise. If the patient has documented in writing their preference for care in an emergency situation, I ask for a copy for their chart.
When should patients be referred to a specialty palliative care program?
I tell our oncology teams to involve me after they have tried to intervene, but unsuccessfully because of the patient having intractable symptoms, such as pain, or the disease is not responding to treatments. Or, because there are significant communication or health literacy barriers. Or, because there are challenging family dynamics that are impeding progress in establishing goals of care.
A physician should refer to specialty palliative care when there are multiple comorbid conditions that impact a patient’s prognosis and ability to tolerate treatments. These patients will need detailed symptom management and nuanced conversations about the delicate balance of maintaining quality of life and trying to address their malignancy while also avoiding treatments that may do more harm than good.
At the end of the day, all patients with serious illnesses deserve a palliative care approach to their care from all of their clinicians, not just from the palliative care team. By continuously honing and implementing primary palliative care skills, oncology teams can feel empowered to meet the needs of their patients themselves, strengthening their bond with their patients making truly patient-centered care much more likely.
Ms. D’Ambruoso is a hospice and palliative care nurse practitioner for UCLA Health Cancer Care, Santa Monica, Calif.
I recently met Jane, a 53-year-old woman with metastatic breast cancer. She was referred to me by the breast oncology team, which routinely refers all metastatic patients to our palliative care clinic.
Clocking in at under 20 minutes, my consultation with Jane might have been one of my shortest on record. Not only had the breast oncology team already addressed Jane’s symptoms, which mainly consisted of hot flashes and joint pain attributable to treatment with an aromatase inhibitor, but they had already started planning ahead for the future of her illness. Jane had completed an advance directive and had a realistic and hopeful perspective on how her illness would progress. She understood the goal of her treatment was to “keep the cancer asleep,” as she put it, and she was very clear about her own goals: to live long enough to see her granddaughter graduate from high school in 2 years and to take a long-awaited trip to Australia later in 2023.
There wasn’t much for me to do. In fact, I daresay that Jane really did not need to see a palliative care specialist because the primary palliative care she was receiving from the breast oncology team was superb. Jane was receiving excellent symptom management from a nurse practitioner and oncologist, plus a social worker provided her with coping strategies. She was already having conversations with her primary medical team and her family about what to expect in the future and how to plan ahead for all possible outcomes.
When should a patient be referred to palliative care?
Integrating palliative care into routine oncologic care need not always require the time and skill of a palliative care team for every patient. Oncology providers can provide basic palliative care services without consulting a palliative care specialist.
For example, if a primary care doctor tried to refer every patient with hypertension to cardiology, the cardiologist would probably say that primary care should be able to handle basic hypertension management. In my experience from working in an oncology clinic for the past 9 years, I’ve found that oncology providers don’t need to refer every advanced cancer patient to our palliative care program. Most oncologists have good communication skills and are more than capable of managing symptoms for patients.
But don’t get me wrong.
Palliative care for all?
In 2010, Jennifer S. Temel MD, published a landmark study in the New England Journal of Medicine that demonstrated significant improvements in quality of life and mood in patients with metastatic lung cancer who received concurrent palliative care. After the study was published many voices inside oncology and palliative care began to advocate for a “palliative care for all” approach to patients with metastatic disease. But this is often interpreted as “specialty palliative care for all,” rather than its original intended meaning that all patients with metastatic disease receive the essential elements of palliative care (biopsychosocial symptom support and conversations about goals of care) either through their primary oncology teams or, if needed, specialty palliative care teams.
The fact is that most specialty palliative care clinics do not have the manpower to meet the needs of all patients with advanced cancers, much less all patients living with serious illness. A main goal of integrating palliative care into routine outpatient health care has always been (and in my opinion, should continue to be) to enhance the primary palliative care skills of specialists, such as oncologists and cardiologists, who care for some of our sickest patients.
This could take many forms. For one, it can be helpful to screen patients for palliative care needs. The American College of Surgeons Commission on Cancer mandates distress screening for all patients as a condition of accreditation. Distress screening using a validated tool such as the National Comprehensive Cancer Network Distress Thermometer can differentiate patients who have minimal distress and may not need much additional support beyond what is provided by their oncology team from those whose distress feels unmanageable and overwhelming.
In terms of primary palliative care symptom management, most oncology teams I work with are comfortable prescribing basic medications for pain, nausea, constipation, and anxiety. They’re also comfortable referring oncology patients for nutrition needs while undergoing chemotherapy as well as to social work and spiritual care for emotional support and counseling.
Oncology teams should continually work on communications skills. They should use “Ask, Tell, Ask” to elicit prognostic awareness, convey critical information, and assess for recall and understanding at pivotal points in the cancer journey, such as when the disease progresses or the patient’s clinical condition changes. They should practice a normalizing script they can use to introduce advance care planning to their patients in the first few visits. When I meet with a patient for the first time, I usually begin by asking if they have prepared an advanced directive. If not, I ask if they’ve thought about who will make medical decisions for them should the need arise. If the patient has documented in writing their preference for care in an emergency situation, I ask for a copy for their chart.
When should patients be referred to a specialty palliative care program?
I tell our oncology teams to involve me after they have tried to intervene, but unsuccessfully because of the patient having intractable symptoms, such as pain, or the disease is not responding to treatments. Or, because there are significant communication or health literacy barriers. Or, because there are challenging family dynamics that are impeding progress in establishing goals of care.
A physician should refer to specialty palliative care when there are multiple comorbid conditions that impact a patient’s prognosis and ability to tolerate treatments. These patients will need detailed symptom management and nuanced conversations about the delicate balance of maintaining quality of life and trying to address their malignancy while also avoiding treatments that may do more harm than good.
At the end of the day, all patients with serious illnesses deserve a palliative care approach to their care from all of their clinicians, not just from the palliative care team. By continuously honing and implementing primary palliative care skills, oncology teams can feel empowered to meet the needs of their patients themselves, strengthening their bond with their patients making truly patient-centered care much more likely.
Ms. D’Ambruoso is a hospice and palliative care nurse practitioner for UCLA Health Cancer Care, Santa Monica, Calif.
The Respect for Marriage Act: How this law supports the health and well-being of LGBTQ+ youth
Childhood and adolescence are periods of life with rapid growth and development in which the psychosocial factors of one’s environment can have a profound effect on health. There is increasing evidence that adverse childhood experiences (ACEs) can have significant negative effects on long-term health with effects persisting into subsequent generations.1 Youth themselves, however, often do not have the voice, ability, or political power to advocate for safe and more supportive environments that are essential to their well-being. Thus, advocacy has been central to the profession of pediatrics since its inception, where providers can partner with their patients, families, and communities to push for changes in the environments in which youth live and grow.2
LGBTQ+ youth are known to be at increased risk for ACEs because of the stress that comes from being part of a minority group and the discrimination they experience by their families, communities, and society at large. These factors within their environments have been shown to be associated with increased rates of anxiety, depression, substance use, sexually transmitted infections, and homelessness.3 As with other health outcomes that have been linked to the social determinants of health, these disparities are not inevitable and could be greatly improved upon through advocacy and changes in the environments of LGBTQ+ youth.
Marriage equality (the recognition that same-sex couples have the same legal right to marry as opposite-sex couples) has been shown to be not only a political issue, but one that affects health. The debates surrounding marriage equality have contributed to minority stress by questioning the validity of same-sex relationships and assigning them less value relative to opposite-sex relationships.4 In 1996, the U.S. Congress passed the Defense of Marriage Act (DOMA), which federally defined marriage as being legally recognized only between opposite-sex couples.
Individual states then continued the marriage equality debate by passing individual state laws either allowing or prohibiting same-sex marriage. During this time, it was shown that, in states where same-sex marriage was legally prohibited, LGBTQ+ adults reported significantly higher rates of generalized anxiety disorder, alcohol use disorder, any mood disorder, and psychiatric comorbidity when compared with states without a legal ban on same-sex marriage.5
Using data from the Youth Risk Behavior Surveillance System, it was shown that state policies recognizing same-sex marriage were associated with a 7% relative reduction in suicide attempts reported by adolescent sexual minority students compared with before these policies.6 It was also shown that children with same-sex parents were overall less likely to have private health insurance, but this disparity was improved in states that legally recognized same-sex marriage and allowed second-parent adoptions.7
In 2013, the U.S. Supreme Court ruled that DOMA was unconstitutional, requiring the federal government to legally recognize same-sex marriages for the purposes of federal benefits. In 2015, the U.S. Supreme Court further ruled that same-sex couples are guaranteed the fundamental right to marry, requiring that all states issue marriage licenses to same-sex couples. These rulings were associated with a decrease in reported levels of stigma over time and increased reported levels of family support, particularly for those in same-sex relationships.8
The Respect for Marriage Act (RFMA) was passed by the U.S. Congress and signed into law by President Biden on Dec. 13, 2022. This law officially repeals DOMA and requires all states and the federal government to recognize same-sex marriages performed in any U.S. state or territory.9
If the U.S. Supreme Court were to overturn the 2015 marriage equality decision, individual state laws ensuring or banning same-sex marriage would again be in effect. However, the RFMA ensures that all states continue to recognize same-sex marriages performed in any U.S. state or territory (even if that state itself bans same-sex marriage). While we do not yet have any studies or data regarding the effect of the RFMA on public health, we can expect positive effects by drawing on the previous evidence on the effect of marriage equality and its effect on the health and well-being of LGBTQ+ individuals. By establishing marriage equality in the United States, our government institutions are affirming the relationships and identities of those in same-sex relationships, with the potential effect of helping to destigmatize the LGBTQ+ community.
Since 2002, the American Academy of Pediatrics has recommended that pediatricians “support the right of every child and family to the financial, psychological, and legal security that results from having legally recognized parents who are committed to each other and to the welfare of their children,” acknowledging that “legislative initiatives assuring legal status equivalent to marriage for gay and lesbian partners … can also attend to providing security and permanence for the children of those partnerships.”10 While changes in legal marriage equality are likely to have a positive effect on those within the LGBTQ+ community, it should also be understood that this will not solve all of the psychosocial effects and resultant health disparities that these children face.
A recent scoping review highlights that, as the result of marriage equality progress, sexual minority adults have reported increased social acceptance and reduced stigma across individual, community, and societal levels, but that sexual minority stigma continues to persist across all levels.11
As pediatricians, we can continue to support LGBTQ+ patients and parents by providing care in a safe and affirming environment in which families understand and embrace the healthy development of gender identity and sexuality in an open and destigmatized manner. Delivering care using this approach in and of itself can be seen as advocacy to promote health and well-being within minoritized populations. Pediatricians are also encouraged to become engaged in local and national advocacy initiatives to have a broader effect in the fight for health equity in minority populations, including LGBTQ+ families and youth.
Pediatricians should work with their patients, families, and communities to advocate for structural change needed to address the social determinants of health for optimal growth and development.
Dr. Warus is an adolescent medicine physician who specializes in care for transgender and gender-nonconforming youth, and LGBTQ health for youth at Children’s Hospital of Los Angeles. He is an assistant professor of pediatrics at University of Southern California, Los Angeles.
Resources
Bright Futures – Promoting Healthy Development of Sexuality and Gender Identity (Implementation Tip Sheet): https://downloads.aap.org/AAP/PDF/BF_HealthySexualityGenderIdentity_Tipsheet.pdf
Bright Futures – Implementing Social Determinants of Health Into Health Supervision Visits (Implementation Tip Sheet): https://downloads.aap.org/AAP/PDF/Bright%20Futures/BF_IntegrateSDoH_Tipsheet.pdf?_ga=2.214227031.1330574154.1673910248-58875083.1673910248
American Academy of Pediatrics – Advocacy Website: https://www.aap.org/en/advocacy/
References
1. Hughes K et al. Lancet Public Health. 2017;2(8):e356-66.
2. Camero K and Javier JR. Pediatr Clin N Am. 2023;70:43-51.
3. Lund EM and Burgess CM. Prim Care Clin Office Pract. 2021;48:179-89.
4. Buffie WC. Am J Public Health. 2011;101(6):986-90.
5. Hatzenbuehler ML et al. Am J Public Health. 2010;100:452-9.
6. Raifman J et al. JAMA Pediatr. 2017;171(4):350-6.
7. Gonzales G and Blewett LA. Pediatrics. 2013;132(4):703-11.
8. Ogolsky BG et al. J Fam Psychol. 2019;33(4):422-32.
9. Library of Congress. H.R.8404 – 117th Congress (2021-2022): Respect for Marriage Act. 2022 Dec 13. www.congress.gov/bill/117th-congress/house-bill/8404/text.
10. Perrin EC and Committee on Psychosocial Aspects of Child and Family Health. Pediatrics. 2002;109(2):341-4.
11. Drabble LA et al. PLoS ONE. 2021;16(5):e0249125.
Childhood and adolescence are periods of life with rapid growth and development in which the psychosocial factors of one’s environment can have a profound effect on health. There is increasing evidence that adverse childhood experiences (ACEs) can have significant negative effects on long-term health with effects persisting into subsequent generations.1 Youth themselves, however, often do not have the voice, ability, or political power to advocate for safe and more supportive environments that are essential to their well-being. Thus, advocacy has been central to the profession of pediatrics since its inception, where providers can partner with their patients, families, and communities to push for changes in the environments in which youth live and grow.2
LGBTQ+ youth are known to be at increased risk for ACEs because of the stress that comes from being part of a minority group and the discrimination they experience by their families, communities, and society at large. These factors within their environments have been shown to be associated with increased rates of anxiety, depression, substance use, sexually transmitted infections, and homelessness.3 As with other health outcomes that have been linked to the social determinants of health, these disparities are not inevitable and could be greatly improved upon through advocacy and changes in the environments of LGBTQ+ youth.
Marriage equality (the recognition that same-sex couples have the same legal right to marry as opposite-sex couples) has been shown to be not only a political issue, but one that affects health. The debates surrounding marriage equality have contributed to minority stress by questioning the validity of same-sex relationships and assigning them less value relative to opposite-sex relationships.4 In 1996, the U.S. Congress passed the Defense of Marriage Act (DOMA), which federally defined marriage as being legally recognized only between opposite-sex couples.
Individual states then continued the marriage equality debate by passing individual state laws either allowing or prohibiting same-sex marriage. During this time, it was shown that, in states where same-sex marriage was legally prohibited, LGBTQ+ adults reported significantly higher rates of generalized anxiety disorder, alcohol use disorder, any mood disorder, and psychiatric comorbidity when compared with states without a legal ban on same-sex marriage.5
Using data from the Youth Risk Behavior Surveillance System, it was shown that state policies recognizing same-sex marriage were associated with a 7% relative reduction in suicide attempts reported by adolescent sexual minority students compared with before these policies.6 It was also shown that children with same-sex parents were overall less likely to have private health insurance, but this disparity was improved in states that legally recognized same-sex marriage and allowed second-parent adoptions.7
In 2013, the U.S. Supreme Court ruled that DOMA was unconstitutional, requiring the federal government to legally recognize same-sex marriages for the purposes of federal benefits. In 2015, the U.S. Supreme Court further ruled that same-sex couples are guaranteed the fundamental right to marry, requiring that all states issue marriage licenses to same-sex couples. These rulings were associated with a decrease in reported levels of stigma over time and increased reported levels of family support, particularly for those in same-sex relationships.8
The Respect for Marriage Act (RFMA) was passed by the U.S. Congress and signed into law by President Biden on Dec. 13, 2022. This law officially repeals DOMA and requires all states and the federal government to recognize same-sex marriages performed in any U.S. state or territory.9
If the U.S. Supreme Court were to overturn the 2015 marriage equality decision, individual state laws ensuring or banning same-sex marriage would again be in effect. However, the RFMA ensures that all states continue to recognize same-sex marriages performed in any U.S. state or territory (even if that state itself bans same-sex marriage). While we do not yet have any studies or data regarding the effect of the RFMA on public health, we can expect positive effects by drawing on the previous evidence on the effect of marriage equality and its effect on the health and well-being of LGBTQ+ individuals. By establishing marriage equality in the United States, our government institutions are affirming the relationships and identities of those in same-sex relationships, with the potential effect of helping to destigmatize the LGBTQ+ community.
Since 2002, the American Academy of Pediatrics has recommended that pediatricians “support the right of every child and family to the financial, psychological, and legal security that results from having legally recognized parents who are committed to each other and to the welfare of their children,” acknowledging that “legislative initiatives assuring legal status equivalent to marriage for gay and lesbian partners … can also attend to providing security and permanence for the children of those partnerships.”10 While changes in legal marriage equality are likely to have a positive effect on those within the LGBTQ+ community, it should also be understood that this will not solve all of the psychosocial effects and resultant health disparities that these children face.
A recent scoping review highlights that, as the result of marriage equality progress, sexual minority adults have reported increased social acceptance and reduced stigma across individual, community, and societal levels, but that sexual minority stigma continues to persist across all levels.11
As pediatricians, we can continue to support LGBTQ+ patients and parents by providing care in a safe and affirming environment in which families understand and embrace the healthy development of gender identity and sexuality in an open and destigmatized manner. Delivering care using this approach in and of itself can be seen as advocacy to promote health and well-being within minoritized populations. Pediatricians are also encouraged to become engaged in local and national advocacy initiatives to have a broader effect in the fight for health equity in minority populations, including LGBTQ+ families and youth.
Pediatricians should work with their patients, families, and communities to advocate for structural change needed to address the social determinants of health for optimal growth and development.
Dr. Warus is an adolescent medicine physician who specializes in care for transgender and gender-nonconforming youth, and LGBTQ health for youth at Children’s Hospital of Los Angeles. He is an assistant professor of pediatrics at University of Southern California, Los Angeles.
Resources
Bright Futures – Promoting Healthy Development of Sexuality and Gender Identity (Implementation Tip Sheet): https://downloads.aap.org/AAP/PDF/BF_HealthySexualityGenderIdentity_Tipsheet.pdf
Bright Futures – Implementing Social Determinants of Health Into Health Supervision Visits (Implementation Tip Sheet): https://downloads.aap.org/AAP/PDF/Bright%20Futures/BF_IntegrateSDoH_Tipsheet.pdf?_ga=2.214227031.1330574154.1673910248-58875083.1673910248
American Academy of Pediatrics – Advocacy Website: https://www.aap.org/en/advocacy/
References
1. Hughes K et al. Lancet Public Health. 2017;2(8):e356-66.
2. Camero K and Javier JR. Pediatr Clin N Am. 2023;70:43-51.
3. Lund EM and Burgess CM. Prim Care Clin Office Pract. 2021;48:179-89.
4. Buffie WC. Am J Public Health. 2011;101(6):986-90.
5. Hatzenbuehler ML et al. Am J Public Health. 2010;100:452-9.
6. Raifman J et al. JAMA Pediatr. 2017;171(4):350-6.
7. Gonzales G and Blewett LA. Pediatrics. 2013;132(4):703-11.
8. Ogolsky BG et al. J Fam Psychol. 2019;33(4):422-32.
9. Library of Congress. H.R.8404 – 117th Congress (2021-2022): Respect for Marriage Act. 2022 Dec 13. www.congress.gov/bill/117th-congress/house-bill/8404/text.
10. Perrin EC and Committee on Psychosocial Aspects of Child and Family Health. Pediatrics. 2002;109(2):341-4.
11. Drabble LA et al. PLoS ONE. 2021;16(5):e0249125.
Childhood and adolescence are periods of life with rapid growth and development in which the psychosocial factors of one’s environment can have a profound effect on health. There is increasing evidence that adverse childhood experiences (ACEs) can have significant negative effects on long-term health with effects persisting into subsequent generations.1 Youth themselves, however, often do not have the voice, ability, or political power to advocate for safe and more supportive environments that are essential to their well-being. Thus, advocacy has been central to the profession of pediatrics since its inception, where providers can partner with their patients, families, and communities to push for changes in the environments in which youth live and grow.2
LGBTQ+ youth are known to be at increased risk for ACEs because of the stress that comes from being part of a minority group and the discrimination they experience by their families, communities, and society at large. These factors within their environments have been shown to be associated with increased rates of anxiety, depression, substance use, sexually transmitted infections, and homelessness.3 As with other health outcomes that have been linked to the social determinants of health, these disparities are not inevitable and could be greatly improved upon through advocacy and changes in the environments of LGBTQ+ youth.
Marriage equality (the recognition that same-sex couples have the same legal right to marry as opposite-sex couples) has been shown to be not only a political issue, but one that affects health. The debates surrounding marriage equality have contributed to minority stress by questioning the validity of same-sex relationships and assigning them less value relative to opposite-sex relationships.4 In 1996, the U.S. Congress passed the Defense of Marriage Act (DOMA), which federally defined marriage as being legally recognized only between opposite-sex couples.
Individual states then continued the marriage equality debate by passing individual state laws either allowing or prohibiting same-sex marriage. During this time, it was shown that, in states where same-sex marriage was legally prohibited, LGBTQ+ adults reported significantly higher rates of generalized anxiety disorder, alcohol use disorder, any mood disorder, and psychiatric comorbidity when compared with states without a legal ban on same-sex marriage.5
Using data from the Youth Risk Behavior Surveillance System, it was shown that state policies recognizing same-sex marriage were associated with a 7% relative reduction in suicide attempts reported by adolescent sexual minority students compared with before these policies.6 It was also shown that children with same-sex parents were overall less likely to have private health insurance, but this disparity was improved in states that legally recognized same-sex marriage and allowed second-parent adoptions.7
In 2013, the U.S. Supreme Court ruled that DOMA was unconstitutional, requiring the federal government to legally recognize same-sex marriages for the purposes of federal benefits. In 2015, the U.S. Supreme Court further ruled that same-sex couples are guaranteed the fundamental right to marry, requiring that all states issue marriage licenses to same-sex couples. These rulings were associated with a decrease in reported levels of stigma over time and increased reported levels of family support, particularly for those in same-sex relationships.8
The Respect for Marriage Act (RFMA) was passed by the U.S. Congress and signed into law by President Biden on Dec. 13, 2022. This law officially repeals DOMA and requires all states and the federal government to recognize same-sex marriages performed in any U.S. state or territory.9
If the U.S. Supreme Court were to overturn the 2015 marriage equality decision, individual state laws ensuring or banning same-sex marriage would again be in effect. However, the RFMA ensures that all states continue to recognize same-sex marriages performed in any U.S. state or territory (even if that state itself bans same-sex marriage). While we do not yet have any studies or data regarding the effect of the RFMA on public health, we can expect positive effects by drawing on the previous evidence on the effect of marriage equality and its effect on the health and well-being of LGBTQ+ individuals. By establishing marriage equality in the United States, our government institutions are affirming the relationships and identities of those in same-sex relationships, with the potential effect of helping to destigmatize the LGBTQ+ community.
Since 2002, the American Academy of Pediatrics has recommended that pediatricians “support the right of every child and family to the financial, psychological, and legal security that results from having legally recognized parents who are committed to each other and to the welfare of their children,” acknowledging that “legislative initiatives assuring legal status equivalent to marriage for gay and lesbian partners … can also attend to providing security and permanence for the children of those partnerships.”10 While changes in legal marriage equality are likely to have a positive effect on those within the LGBTQ+ community, it should also be understood that this will not solve all of the psychosocial effects and resultant health disparities that these children face.
A recent scoping review highlights that, as the result of marriage equality progress, sexual minority adults have reported increased social acceptance and reduced stigma across individual, community, and societal levels, but that sexual minority stigma continues to persist across all levels.11
As pediatricians, we can continue to support LGBTQ+ patients and parents by providing care in a safe and affirming environment in which families understand and embrace the healthy development of gender identity and sexuality in an open and destigmatized manner. Delivering care using this approach in and of itself can be seen as advocacy to promote health and well-being within minoritized populations. Pediatricians are also encouraged to become engaged in local and national advocacy initiatives to have a broader effect in the fight for health equity in minority populations, including LGBTQ+ families and youth.
Pediatricians should work with their patients, families, and communities to advocate for structural change needed to address the social determinants of health for optimal growth and development.
Dr. Warus is an adolescent medicine physician who specializes in care for transgender and gender-nonconforming youth, and LGBTQ health for youth at Children’s Hospital of Los Angeles. He is an assistant professor of pediatrics at University of Southern California, Los Angeles.
Resources
Bright Futures – Promoting Healthy Development of Sexuality and Gender Identity (Implementation Tip Sheet): https://downloads.aap.org/AAP/PDF/BF_HealthySexualityGenderIdentity_Tipsheet.pdf
Bright Futures – Implementing Social Determinants of Health Into Health Supervision Visits (Implementation Tip Sheet): https://downloads.aap.org/AAP/PDF/Bright%20Futures/BF_IntegrateSDoH_Tipsheet.pdf?_ga=2.214227031.1330574154.1673910248-58875083.1673910248
American Academy of Pediatrics – Advocacy Website: https://www.aap.org/en/advocacy/
References
1. Hughes K et al. Lancet Public Health. 2017;2(8):e356-66.
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4. Buffie WC. Am J Public Health. 2011;101(6):986-90.
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7. Gonzales G and Blewett LA. Pediatrics. 2013;132(4):703-11.
8. Ogolsky BG et al. J Fam Psychol. 2019;33(4):422-32.
9. Library of Congress. H.R.8404 – 117th Congress (2021-2022): Respect for Marriage Act. 2022 Dec 13. www.congress.gov/bill/117th-congress/house-bill/8404/text.
10. Perrin EC and Committee on Psychosocial Aspects of Child and Family Health. Pediatrics. 2002;109(2):341-4.
11. Drabble LA et al. PLoS ONE. 2021;16(5):e0249125.