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Social determinants of health and the hospitalist
Are access to housing and food as important as therapeutics?
While physicians acknowledge that the social determinants of health can impact outcomes from medical care, some may feel that trying to address factors such as homelessness, food insecurity, or lack of ready access to transportation or pharmacy services is just not part of the doctor’s job. A majority of 621 physicians surveyed in the summer of 2017 by Salt Lake City–based health care intelligence firm Leavitt Partners say they are neither capable of nor responsible for addressing such issues.1
But that view may become unsustainable as the U.S. health care system continues to advance toward value- and population-based models of health care and as evidence mounts that social factors are important contributors to costly outcomes, such as avoidable hospital readmissions or emergency room visits. A recent report from the Robert Wood Johnson Foundation estimates that at least 40% of health outcomes are the result of social and economic factors, while only 20% can be attributed to medical care.2
“This is a hot topic – getting a lot of attention these days,” said hospitalist and care transitions expert Ramon Jacobs-Shaw, MD, MPA, regional medical officer for CareMore Health, a California-based physician-led health delivery organization and subsidiary of Anthem. “If you go around the country, some doctors still see social factors as the realm of the social worker. But large health care organizations are coming to recognize that social determinants are huge contributors to the health of their members and to the outcomes of their care.”
Hospitalists could be the natural providers to delve into the specific psychosocial aspects of their patients’ lives, or try to figure out how those factors contribute to health care needs, Dr. Jacobs-Shaw said. They typically confront such issues while the patient is in the hospital bed, but what are the steps that led to the hospitalization in the first place? What will happen after the patient is discharged?
“For example, if patients lack transportation, how can they get to their follow-up medical appointment in the primary care office in order to manage their diabetes? If you can’t follow up with them, their diabetes could get out of control, with complications as a result, such as an infected wound,” he said. Another big issue is access to affordable medications. “CareMore has pharmacists embedded on our care teams. They try to figure out the best medicine for the patient but at the lowest cost. They meet individually with patients and do medication counseling, particularly for those with polypharmacy issues.”
Making health care more equitable
Dr. Jacobs-Shaw has long held a personal interest in issues of inclusiveness, diversity, and how to make health care more equitable for historically underserved groups. Asking how to have a bigger impact on these issues is what brought him, after 13 years as a hospitalist on the East Coast, to CareMore, a company that has made addressing social needs central to its care model. “In California, where I am based, we are a wrap-around for patients who are covered by Medicare Advantage plans. We are whatever the patient needs us to be.”
He oversees a group of hospitalists, dubbed extensivists, who provide advanced patient care and chronic disease management. In the extensivist model, physicians and advanced practice nurses provide comprehensive and coordinated care to patients with complex medical issues, taking their scope of practice beyond the hospital into homes, post-acute care facilities, and other settings, with a focus on keeping patients healthier and reducing readmission.3
“Our patients get access to extra services and resources, some of which are available at our care centers – which are one-stop outpatient facilities. We also focus on a lot of things physicians didn’t historically think were within their wheelhouse. Hospitalists deal with these kinds of issues every day, but may not label them as social determinants of health,” Dr. Jacobs-Shaw said. He emphasized that hospitalists should realize that they are not powerless to address these issues, working in partnership with other groups in and out of the hospital. They should also know that health care payers increasingly are dedicating resources to these issues.
“We just started trying to address homelessness through a pilot in Orange County, working with nonprofit organizations and philanthropy to offer a transitional site of care for our patients who are being discharged from the hospital and have housing insecurity issues, to get them transitioned into more secure housing,” Dr. Jacobs-Shaw said. CareMore also has a transportation collaborative that offers no-cost, nonemergency transportation to medical appointments. “That’s meeting them where they are at, based on an assessment of their needs and resources.”
What are social determinants?
The social determinants of health – social, environmental, and other nonmedical factors that contribute to overall health status and medical need – have been defined by the World Health Organization as: “conditions in which people are born, grow, live, work, and age.” That is a broad complex of overlapping social and systems issues, but it provides a context for a broader understanding of the patient’s health and response to medical interventions.
Socioeconomic status is a huge determinant. Level of education may be more important than income if the person lacks the health literacy to navigate the system and access needed care. Housing instability may include poor sanitation, substandard dwellings, or unsafe neighborhoods – all of which can affect a person’s well-being. Environmental health may include compromised air quality – which can impact pulmonary health. Other issues include access to employment and child care, utility needs, and interpersonal violence.
A 2014 paper in Annals of Internal Medicine found that residence within a disadvantaged neighborhood was a factor in hospital readmission rates as often as was chronic pulmonary disease.4 A recent report on social determinants of health by the National Institute for Health Care Management notes that patients with food insecurity are 2.4 times more likely to go to the emergency room, while those with transportation needs are 2.6 times more likely.5
What can health care leaders do to better equip their clinicians and teams to help patients deal with this array of complex needs? Intermountain Healthcare, based in Salt Lake City, spearheaded in 2018 the development of the Alliance for the Determinants of Health, starting in the communities of Ogden and St. George, Utah. The Alliance seeks to promote health, improve access to care, and decrease health care costs through a charitable contribution of $12 million over 3 years to seed collaborative demonstration projects.
Lisa Nichols, assistant vice president for community health at Intermountain, said that, while hospitalists were not directly involved in planning the Alliance, hospitalists and ED physicians have become essential to the patient-screening process for health and social needs.
“We met with hospitalists, emergency departments, and hospital administrators, because we wanted their feedback on how to raise awareness of the social needs of patients,” she said. “They have good ideas. They see the patients who come in from the homeless shelters.”
Other hospitals are subsidizing apartments for homeless patients being discharged from the hospital. CommonSpirit Health, the new national Catholic health care organization formed by the 2019 merger of Dignity Health and Catholic Health Initiatives, has explored how to help create and sustain affordable housing in the communities it serves. Investments like this have inspired others, such as Kaiser Permanente, to get involved in supporting housing initiatives.6
Comprehensive community care
David Meltzer, MD, PhD, a hospitalist and professor of medicine at the University of Chicago, said most hospitalists these days believe social determinants of health are part of their job responsibilities.
“That’s not to say we all do it well. We may fail at addressing some of the barriers our patients face. But I don’t know anyone who still says it’s not their job,” he said.
Since 2012, Dr. Meltzer has led a pilot called Comprehensive Care Physicians (CCP), in which the same physician cares for patients with chronic health problems in the clinic and in the hospital, working with a team of nurse practitioners, social workers, care coordinators, and other specialists. A total of 2,000 patients with chronic health problems were enrolled in the study from 2012 to 2016, half assigned to standard care and half assigned to five CCP doctors. The result: The CCP model has shown large improvements in outcomes – particularly among the more vulnerable, less activated patients, is preferred by patients, and has significantly reduced health care utilization.
The next step for the research team is another randomized controlled trial called Comprehensive Care, Community, and Culture, designed to address unmet social needs. Study group patients will also be screened for unmet social needs and have access to a community health worker and to the initiative’s Artful Living Program, which includes community and cultural activities like yoga and dance classes, cooking classes, art classes, and music concerts. To address the complex dimensions and determinants of health, Dr. Meltzer explained, efforts to improve health must extend to sectors far beyond traditional health care.
“I think trying to understand your patients’ social and nonmedical needs starts with getting to know them, and asking about their needs,” he said. “The better you know them, the better you are able to make medical decisions that will promote positive outcomes.”
Sound Physicians, a national hospitalist company based in Tacoma, Wash., and working in 350 hospitals in 41 states, recently published a blog post on its website about the importance of social determinants of health.7 Sound Physicians participates in value-based care through bundled Medicare/Medicaid contracts based on episodes of care for hospitalized patients with certain diagnoses or DRGs, explained John Dickey, MD, the company’s chief medical officer for population health.
“We’ve been heavily involved in trying to improve cost and outcomes of care since 2015. Social determinants absolutely play into trying to lower costs of care and reduce rates of readmissions, which are often multifactorial in cause,” he said. Hospitalists are uniquely equipped to impact post-acute outcomes, Dr. Dickey said, working in partnership with a position Sound Physicians calls the clinical performance nurse.
“We can also partner with primary care providers, provide education for our hospitalist staff, and work with in-home care supports for patients such as these, who otherwise might end up in a skilled nursing facility – even though they’d rather be at home,” he said.
Innovations at Northwell Health
Northwell Health, a multihospital comprehensive health system serving the New York City metro area and Long Island, has shown innovative leadership in addressing social factors. The 23-hospital system initiated in early 2019 a 15-item Self-Reported Social Determinants Screening Tool, which is now used with hospitalized patients to connect them with the support they need to fully recover and avoid readmissions.
Northwell is also providing professional education on social determinants for different constituencies across its system, said Johanna Martinez, MD, MS, a hospitalist and GME Director of Diversity and Health Equity at the Zucker School of Medicine at Hofstra/Northwell. A day-long training retreat was offered to GME faculty, and learning platforms have been developed for physicians, social workers, nurses, and others.
“One of the questions that comes up is that if you find social needs, what do you do about them?” Dr. Martinez explained. That’s more a difficult challenge, she said, so at Northwell, orthopedic surgeons are now asking patients questions like: “What’s going to happen when you go home? What are your social supports? Can you get to the physical therapist’s office?”
Another example of Northwell’s innovations is its Food as Health Program, initially piloted at Long Island Jewish Hospital in Valley Stream, N.Y. Hospitalized patients are asked two questions using a validated screening tool called the Hunger Vital Sign to identify their food insecurities.8 Those who answer yes are referred to a dietitian, and if they have a nutrition-related diagnosis, they enter the multidisciplinary wraparound program.
A key element is the food and health center, located on the hospital campus, where they can get food to take home and referrals to other services, with culturally tailored, disease-specific food education incorporated into the discharge plan. One of the partnering organizations is Island Harvest Food Bank, which helps about 1 in every 10 residents of Long Island with their food insecurity issues.
“When I talk to clinicians, most of us went into medicine to save lives and cure people. Yet the research shows that no matter who we are, we can’t do the best work that our patients need unless we consider their social determinants,” Dr. Martinez said. Ultimately, she noted, there is a need to change the culture of health care. “We have to create system change, reimbursement change, policy change.”
Omolara Uwemedimo, MD, MPH, associate professor of pediatrics and occupational medicine at Northwell and a former nocturnist, said the treatment of illness and health improvement don’t begin in the hospital, they begin in the community. Identifying where people are struggling and what communities they come from requires a broader view of the provider’s role. “Are patients who are readmitted to the hospital generally coming from certain demographics or from certain zip codes?” she asked. “Start there. How can we better connect with those communities?”
Education is key
In 2020 and beyond, hospitalists will hear more about the social determinants of health, Dr. Jacobs-Shaw concluded. “Without addressing those social determinants, we aren’t going to be able to meaningfully impact outcomes or be effective stewards of health care costs – addressing the psychosocial factors and root causes of patients coming in and out of the hospital.”
He added that self-education is key for hospitalists and the teams they work with – to be more aware of the link between health outcomes and social determinants. Guidelines and other resources on social determinants of health are available from the American College of Physicians and the American Association of Family Physicians. ACP issued a position paper on addressing social determinants of health to improve patient care,while AAFP has a research page on its website dedicated to social determinants of health, highlighting a number of initiatives and resources for physicians and others.9
The American Hospital Association has produced fact sheets on ICD-10CM code categories for social determinants of health, including 11 ICD-10 “Z” codes, numbered Z55-Z65, which can be used for coding interventions to address social determinants of health. Other experts are looking at how to adapt the electronic health record to capture sociodemographic and behavioral factors, and then trigger referrals to resources in the hospital and the broader community, and how to mobilize artificial intelligence and machine learning to better identify social needs.
“Our doctors really want to be able to take care of the whole patient, while being stewards of health care resources. But sometimes we feel powerless and wonder how we can have a bigger impact on people, on populations” Dr. Jacobs-Shaw said. “Remember it only takes one voice within an organization to start to elevate this topic.”
References
1. Rappleye E. Physicians say social determinants of health are not their responsibility. Becker’s Hospital Review. 2018 May 15.
2. Robert Wood Johnson Foundation, University of Wisconsin Population Health Institute. County Health Rankings, 2014.
3. Freeman, GA. The extensivist model. Health Leaders Magazine, 2016 Sep 15.
4. Kind AJ et al. Neighborhood socioeconomic disadvantage and 30-day rehospitalization: A retrospective cohort study. Ann Intern Med. 2014 Dec 2;161(11):765-74.
5. National Institute for Health Care Management. Addressing social determinants of health can improve community health & reduce costs.
6. Vial PB. Boundless collaboration: A philosophy for sustainable and stabilizing housing investment strategies. Health Progress: Journal of the Catholic Health Association of the United States. September-October 2019.
7. Social determinants of health: New solutions for growing complexities. Op-Med, a blog by Sound Physicians. 2019 Aug 1.
8. The hunger vital sign: A new standard of care for preventive health.
9. Daniel H et al. Addressing social determinants to improve patient care and promote health equity: An American College of Physicians position paper. Ann Intern Med. 2018;168:557-578.
Are access to housing and food as important as therapeutics?
Are access to housing and food as important as therapeutics?
While physicians acknowledge that the social determinants of health can impact outcomes from medical care, some may feel that trying to address factors such as homelessness, food insecurity, or lack of ready access to transportation or pharmacy services is just not part of the doctor’s job. A majority of 621 physicians surveyed in the summer of 2017 by Salt Lake City–based health care intelligence firm Leavitt Partners say they are neither capable of nor responsible for addressing such issues.1
But that view may become unsustainable as the U.S. health care system continues to advance toward value- and population-based models of health care and as evidence mounts that social factors are important contributors to costly outcomes, such as avoidable hospital readmissions or emergency room visits. A recent report from the Robert Wood Johnson Foundation estimates that at least 40% of health outcomes are the result of social and economic factors, while only 20% can be attributed to medical care.2
“This is a hot topic – getting a lot of attention these days,” said hospitalist and care transitions expert Ramon Jacobs-Shaw, MD, MPA, regional medical officer for CareMore Health, a California-based physician-led health delivery organization and subsidiary of Anthem. “If you go around the country, some doctors still see social factors as the realm of the social worker. But large health care organizations are coming to recognize that social determinants are huge contributors to the health of their members and to the outcomes of their care.”
Hospitalists could be the natural providers to delve into the specific psychosocial aspects of their patients’ lives, or try to figure out how those factors contribute to health care needs, Dr. Jacobs-Shaw said. They typically confront such issues while the patient is in the hospital bed, but what are the steps that led to the hospitalization in the first place? What will happen after the patient is discharged?
“For example, if patients lack transportation, how can they get to their follow-up medical appointment in the primary care office in order to manage their diabetes? If you can’t follow up with them, their diabetes could get out of control, with complications as a result, such as an infected wound,” he said. Another big issue is access to affordable medications. “CareMore has pharmacists embedded on our care teams. They try to figure out the best medicine for the patient but at the lowest cost. They meet individually with patients and do medication counseling, particularly for those with polypharmacy issues.”
Making health care more equitable
Dr. Jacobs-Shaw has long held a personal interest in issues of inclusiveness, diversity, and how to make health care more equitable for historically underserved groups. Asking how to have a bigger impact on these issues is what brought him, after 13 years as a hospitalist on the East Coast, to CareMore, a company that has made addressing social needs central to its care model. “In California, where I am based, we are a wrap-around for patients who are covered by Medicare Advantage plans. We are whatever the patient needs us to be.”
He oversees a group of hospitalists, dubbed extensivists, who provide advanced patient care and chronic disease management. In the extensivist model, physicians and advanced practice nurses provide comprehensive and coordinated care to patients with complex medical issues, taking their scope of practice beyond the hospital into homes, post-acute care facilities, and other settings, with a focus on keeping patients healthier and reducing readmission.3
“Our patients get access to extra services and resources, some of which are available at our care centers – which are one-stop outpatient facilities. We also focus on a lot of things physicians didn’t historically think were within their wheelhouse. Hospitalists deal with these kinds of issues every day, but may not label them as social determinants of health,” Dr. Jacobs-Shaw said. He emphasized that hospitalists should realize that they are not powerless to address these issues, working in partnership with other groups in and out of the hospital. They should also know that health care payers increasingly are dedicating resources to these issues.
“We just started trying to address homelessness through a pilot in Orange County, working with nonprofit organizations and philanthropy to offer a transitional site of care for our patients who are being discharged from the hospital and have housing insecurity issues, to get them transitioned into more secure housing,” Dr. Jacobs-Shaw said. CareMore also has a transportation collaborative that offers no-cost, nonemergency transportation to medical appointments. “That’s meeting them where they are at, based on an assessment of their needs and resources.”
What are social determinants?
The social determinants of health – social, environmental, and other nonmedical factors that contribute to overall health status and medical need – have been defined by the World Health Organization as: “conditions in which people are born, grow, live, work, and age.” That is a broad complex of overlapping social and systems issues, but it provides a context for a broader understanding of the patient’s health and response to medical interventions.
Socioeconomic status is a huge determinant. Level of education may be more important than income if the person lacks the health literacy to navigate the system and access needed care. Housing instability may include poor sanitation, substandard dwellings, or unsafe neighborhoods – all of which can affect a person’s well-being. Environmental health may include compromised air quality – which can impact pulmonary health. Other issues include access to employment and child care, utility needs, and interpersonal violence.
A 2014 paper in Annals of Internal Medicine found that residence within a disadvantaged neighborhood was a factor in hospital readmission rates as often as was chronic pulmonary disease.4 A recent report on social determinants of health by the National Institute for Health Care Management notes that patients with food insecurity are 2.4 times more likely to go to the emergency room, while those with transportation needs are 2.6 times more likely.5
What can health care leaders do to better equip their clinicians and teams to help patients deal with this array of complex needs? Intermountain Healthcare, based in Salt Lake City, spearheaded in 2018 the development of the Alliance for the Determinants of Health, starting in the communities of Ogden and St. George, Utah. The Alliance seeks to promote health, improve access to care, and decrease health care costs through a charitable contribution of $12 million over 3 years to seed collaborative demonstration projects.
Lisa Nichols, assistant vice president for community health at Intermountain, said that, while hospitalists were not directly involved in planning the Alliance, hospitalists and ED physicians have become essential to the patient-screening process for health and social needs.
“We met with hospitalists, emergency departments, and hospital administrators, because we wanted their feedback on how to raise awareness of the social needs of patients,” she said. “They have good ideas. They see the patients who come in from the homeless shelters.”
Other hospitals are subsidizing apartments for homeless patients being discharged from the hospital. CommonSpirit Health, the new national Catholic health care organization formed by the 2019 merger of Dignity Health and Catholic Health Initiatives, has explored how to help create and sustain affordable housing in the communities it serves. Investments like this have inspired others, such as Kaiser Permanente, to get involved in supporting housing initiatives.6
Comprehensive community care
David Meltzer, MD, PhD, a hospitalist and professor of medicine at the University of Chicago, said most hospitalists these days believe social determinants of health are part of their job responsibilities.
“That’s not to say we all do it well. We may fail at addressing some of the barriers our patients face. But I don’t know anyone who still says it’s not their job,” he said.
Since 2012, Dr. Meltzer has led a pilot called Comprehensive Care Physicians (CCP), in which the same physician cares for patients with chronic health problems in the clinic and in the hospital, working with a team of nurse practitioners, social workers, care coordinators, and other specialists. A total of 2,000 patients with chronic health problems were enrolled in the study from 2012 to 2016, half assigned to standard care and half assigned to five CCP doctors. The result: The CCP model has shown large improvements in outcomes – particularly among the more vulnerable, less activated patients, is preferred by patients, and has significantly reduced health care utilization.
The next step for the research team is another randomized controlled trial called Comprehensive Care, Community, and Culture, designed to address unmet social needs. Study group patients will also be screened for unmet social needs and have access to a community health worker and to the initiative’s Artful Living Program, which includes community and cultural activities like yoga and dance classes, cooking classes, art classes, and music concerts. To address the complex dimensions and determinants of health, Dr. Meltzer explained, efforts to improve health must extend to sectors far beyond traditional health care.
“I think trying to understand your patients’ social and nonmedical needs starts with getting to know them, and asking about their needs,” he said. “The better you know them, the better you are able to make medical decisions that will promote positive outcomes.”
Sound Physicians, a national hospitalist company based in Tacoma, Wash., and working in 350 hospitals in 41 states, recently published a blog post on its website about the importance of social determinants of health.7 Sound Physicians participates in value-based care through bundled Medicare/Medicaid contracts based on episodes of care for hospitalized patients with certain diagnoses or DRGs, explained John Dickey, MD, the company’s chief medical officer for population health.
“We’ve been heavily involved in trying to improve cost and outcomes of care since 2015. Social determinants absolutely play into trying to lower costs of care and reduce rates of readmissions, which are often multifactorial in cause,” he said. Hospitalists are uniquely equipped to impact post-acute outcomes, Dr. Dickey said, working in partnership with a position Sound Physicians calls the clinical performance nurse.
“We can also partner with primary care providers, provide education for our hospitalist staff, and work with in-home care supports for patients such as these, who otherwise might end up in a skilled nursing facility – even though they’d rather be at home,” he said.
Innovations at Northwell Health
Northwell Health, a multihospital comprehensive health system serving the New York City metro area and Long Island, has shown innovative leadership in addressing social factors. The 23-hospital system initiated in early 2019 a 15-item Self-Reported Social Determinants Screening Tool, which is now used with hospitalized patients to connect them with the support they need to fully recover and avoid readmissions.
Northwell is also providing professional education on social determinants for different constituencies across its system, said Johanna Martinez, MD, MS, a hospitalist and GME Director of Diversity and Health Equity at the Zucker School of Medicine at Hofstra/Northwell. A day-long training retreat was offered to GME faculty, and learning platforms have been developed for physicians, social workers, nurses, and others.
“One of the questions that comes up is that if you find social needs, what do you do about them?” Dr. Martinez explained. That’s more a difficult challenge, she said, so at Northwell, orthopedic surgeons are now asking patients questions like: “What’s going to happen when you go home? What are your social supports? Can you get to the physical therapist’s office?”
Another example of Northwell’s innovations is its Food as Health Program, initially piloted at Long Island Jewish Hospital in Valley Stream, N.Y. Hospitalized patients are asked two questions using a validated screening tool called the Hunger Vital Sign to identify their food insecurities.8 Those who answer yes are referred to a dietitian, and if they have a nutrition-related diagnosis, they enter the multidisciplinary wraparound program.
A key element is the food and health center, located on the hospital campus, where they can get food to take home and referrals to other services, with culturally tailored, disease-specific food education incorporated into the discharge plan. One of the partnering organizations is Island Harvest Food Bank, which helps about 1 in every 10 residents of Long Island with their food insecurity issues.
“When I talk to clinicians, most of us went into medicine to save lives and cure people. Yet the research shows that no matter who we are, we can’t do the best work that our patients need unless we consider their social determinants,” Dr. Martinez said. Ultimately, she noted, there is a need to change the culture of health care. “We have to create system change, reimbursement change, policy change.”
Omolara Uwemedimo, MD, MPH, associate professor of pediatrics and occupational medicine at Northwell and a former nocturnist, said the treatment of illness and health improvement don’t begin in the hospital, they begin in the community. Identifying where people are struggling and what communities they come from requires a broader view of the provider’s role. “Are patients who are readmitted to the hospital generally coming from certain demographics or from certain zip codes?” she asked. “Start there. How can we better connect with those communities?”
Education is key
In 2020 and beyond, hospitalists will hear more about the social determinants of health, Dr. Jacobs-Shaw concluded. “Without addressing those social determinants, we aren’t going to be able to meaningfully impact outcomes or be effective stewards of health care costs – addressing the psychosocial factors and root causes of patients coming in and out of the hospital.”
He added that self-education is key for hospitalists and the teams they work with – to be more aware of the link between health outcomes and social determinants. Guidelines and other resources on social determinants of health are available from the American College of Physicians and the American Association of Family Physicians. ACP issued a position paper on addressing social determinants of health to improve patient care,while AAFP has a research page on its website dedicated to social determinants of health, highlighting a number of initiatives and resources for physicians and others.9
The American Hospital Association has produced fact sheets on ICD-10CM code categories for social determinants of health, including 11 ICD-10 “Z” codes, numbered Z55-Z65, which can be used for coding interventions to address social determinants of health. Other experts are looking at how to adapt the electronic health record to capture sociodemographic and behavioral factors, and then trigger referrals to resources in the hospital and the broader community, and how to mobilize artificial intelligence and machine learning to better identify social needs.
“Our doctors really want to be able to take care of the whole patient, while being stewards of health care resources. But sometimes we feel powerless and wonder how we can have a bigger impact on people, on populations” Dr. Jacobs-Shaw said. “Remember it only takes one voice within an organization to start to elevate this topic.”
References
1. Rappleye E. Physicians say social determinants of health are not their responsibility. Becker’s Hospital Review. 2018 May 15.
2. Robert Wood Johnson Foundation, University of Wisconsin Population Health Institute. County Health Rankings, 2014.
3. Freeman, GA. The extensivist model. Health Leaders Magazine, 2016 Sep 15.
4. Kind AJ et al. Neighborhood socioeconomic disadvantage and 30-day rehospitalization: A retrospective cohort study. Ann Intern Med. 2014 Dec 2;161(11):765-74.
5. National Institute for Health Care Management. Addressing social determinants of health can improve community health & reduce costs.
6. Vial PB. Boundless collaboration: A philosophy for sustainable and stabilizing housing investment strategies. Health Progress: Journal of the Catholic Health Association of the United States. September-October 2019.
7. Social determinants of health: New solutions for growing complexities. Op-Med, a blog by Sound Physicians. 2019 Aug 1.
8. The hunger vital sign: A new standard of care for preventive health.
9. Daniel H et al. Addressing social determinants to improve patient care and promote health equity: An American College of Physicians position paper. Ann Intern Med. 2018;168:557-578.
While physicians acknowledge that the social determinants of health can impact outcomes from medical care, some may feel that trying to address factors such as homelessness, food insecurity, or lack of ready access to transportation or pharmacy services is just not part of the doctor’s job. A majority of 621 physicians surveyed in the summer of 2017 by Salt Lake City–based health care intelligence firm Leavitt Partners say they are neither capable of nor responsible for addressing such issues.1
But that view may become unsustainable as the U.S. health care system continues to advance toward value- and population-based models of health care and as evidence mounts that social factors are important contributors to costly outcomes, such as avoidable hospital readmissions or emergency room visits. A recent report from the Robert Wood Johnson Foundation estimates that at least 40% of health outcomes are the result of social and economic factors, while only 20% can be attributed to medical care.2
“This is a hot topic – getting a lot of attention these days,” said hospitalist and care transitions expert Ramon Jacobs-Shaw, MD, MPA, regional medical officer for CareMore Health, a California-based physician-led health delivery organization and subsidiary of Anthem. “If you go around the country, some doctors still see social factors as the realm of the social worker. But large health care organizations are coming to recognize that social determinants are huge contributors to the health of their members and to the outcomes of their care.”
Hospitalists could be the natural providers to delve into the specific psychosocial aspects of their patients’ lives, or try to figure out how those factors contribute to health care needs, Dr. Jacobs-Shaw said. They typically confront such issues while the patient is in the hospital bed, but what are the steps that led to the hospitalization in the first place? What will happen after the patient is discharged?
“For example, if patients lack transportation, how can they get to their follow-up medical appointment in the primary care office in order to manage their diabetes? If you can’t follow up with them, their diabetes could get out of control, with complications as a result, such as an infected wound,” he said. Another big issue is access to affordable medications. “CareMore has pharmacists embedded on our care teams. They try to figure out the best medicine for the patient but at the lowest cost. They meet individually with patients and do medication counseling, particularly for those with polypharmacy issues.”
Making health care more equitable
Dr. Jacobs-Shaw has long held a personal interest in issues of inclusiveness, diversity, and how to make health care more equitable for historically underserved groups. Asking how to have a bigger impact on these issues is what brought him, after 13 years as a hospitalist on the East Coast, to CareMore, a company that has made addressing social needs central to its care model. “In California, where I am based, we are a wrap-around for patients who are covered by Medicare Advantage plans. We are whatever the patient needs us to be.”
He oversees a group of hospitalists, dubbed extensivists, who provide advanced patient care and chronic disease management. In the extensivist model, physicians and advanced practice nurses provide comprehensive and coordinated care to patients with complex medical issues, taking their scope of practice beyond the hospital into homes, post-acute care facilities, and other settings, with a focus on keeping patients healthier and reducing readmission.3
“Our patients get access to extra services and resources, some of which are available at our care centers – which are one-stop outpatient facilities. We also focus on a lot of things physicians didn’t historically think were within their wheelhouse. Hospitalists deal with these kinds of issues every day, but may not label them as social determinants of health,” Dr. Jacobs-Shaw said. He emphasized that hospitalists should realize that they are not powerless to address these issues, working in partnership with other groups in and out of the hospital. They should also know that health care payers increasingly are dedicating resources to these issues.
“We just started trying to address homelessness through a pilot in Orange County, working with nonprofit organizations and philanthropy to offer a transitional site of care for our patients who are being discharged from the hospital and have housing insecurity issues, to get them transitioned into more secure housing,” Dr. Jacobs-Shaw said. CareMore also has a transportation collaborative that offers no-cost, nonemergency transportation to medical appointments. “That’s meeting them where they are at, based on an assessment of their needs and resources.”
What are social determinants?
The social determinants of health – social, environmental, and other nonmedical factors that contribute to overall health status and medical need – have been defined by the World Health Organization as: “conditions in which people are born, grow, live, work, and age.” That is a broad complex of overlapping social and systems issues, but it provides a context for a broader understanding of the patient’s health and response to medical interventions.
Socioeconomic status is a huge determinant. Level of education may be more important than income if the person lacks the health literacy to navigate the system and access needed care. Housing instability may include poor sanitation, substandard dwellings, or unsafe neighborhoods – all of which can affect a person’s well-being. Environmental health may include compromised air quality – which can impact pulmonary health. Other issues include access to employment and child care, utility needs, and interpersonal violence.
A 2014 paper in Annals of Internal Medicine found that residence within a disadvantaged neighborhood was a factor in hospital readmission rates as often as was chronic pulmonary disease.4 A recent report on social determinants of health by the National Institute for Health Care Management notes that patients with food insecurity are 2.4 times more likely to go to the emergency room, while those with transportation needs are 2.6 times more likely.5
What can health care leaders do to better equip their clinicians and teams to help patients deal with this array of complex needs? Intermountain Healthcare, based in Salt Lake City, spearheaded in 2018 the development of the Alliance for the Determinants of Health, starting in the communities of Ogden and St. George, Utah. The Alliance seeks to promote health, improve access to care, and decrease health care costs through a charitable contribution of $12 million over 3 years to seed collaborative demonstration projects.
Lisa Nichols, assistant vice president for community health at Intermountain, said that, while hospitalists were not directly involved in planning the Alliance, hospitalists and ED physicians have become essential to the patient-screening process for health and social needs.
“We met with hospitalists, emergency departments, and hospital administrators, because we wanted their feedback on how to raise awareness of the social needs of patients,” she said. “They have good ideas. They see the patients who come in from the homeless shelters.”
Other hospitals are subsidizing apartments for homeless patients being discharged from the hospital. CommonSpirit Health, the new national Catholic health care organization formed by the 2019 merger of Dignity Health and Catholic Health Initiatives, has explored how to help create and sustain affordable housing in the communities it serves. Investments like this have inspired others, such as Kaiser Permanente, to get involved in supporting housing initiatives.6
Comprehensive community care
David Meltzer, MD, PhD, a hospitalist and professor of medicine at the University of Chicago, said most hospitalists these days believe social determinants of health are part of their job responsibilities.
“That’s not to say we all do it well. We may fail at addressing some of the barriers our patients face. But I don’t know anyone who still says it’s not their job,” he said.
Since 2012, Dr. Meltzer has led a pilot called Comprehensive Care Physicians (CCP), in which the same physician cares for patients with chronic health problems in the clinic and in the hospital, working with a team of nurse practitioners, social workers, care coordinators, and other specialists. A total of 2,000 patients with chronic health problems were enrolled in the study from 2012 to 2016, half assigned to standard care and half assigned to five CCP doctors. The result: The CCP model has shown large improvements in outcomes – particularly among the more vulnerable, less activated patients, is preferred by patients, and has significantly reduced health care utilization.
The next step for the research team is another randomized controlled trial called Comprehensive Care, Community, and Culture, designed to address unmet social needs. Study group patients will also be screened for unmet social needs and have access to a community health worker and to the initiative’s Artful Living Program, which includes community and cultural activities like yoga and dance classes, cooking classes, art classes, and music concerts. To address the complex dimensions and determinants of health, Dr. Meltzer explained, efforts to improve health must extend to sectors far beyond traditional health care.
“I think trying to understand your patients’ social and nonmedical needs starts with getting to know them, and asking about their needs,” he said. “The better you know them, the better you are able to make medical decisions that will promote positive outcomes.”
Sound Physicians, a national hospitalist company based in Tacoma, Wash., and working in 350 hospitals in 41 states, recently published a blog post on its website about the importance of social determinants of health.7 Sound Physicians participates in value-based care through bundled Medicare/Medicaid contracts based on episodes of care for hospitalized patients with certain diagnoses or DRGs, explained John Dickey, MD, the company’s chief medical officer for population health.
“We’ve been heavily involved in trying to improve cost and outcomes of care since 2015. Social determinants absolutely play into trying to lower costs of care and reduce rates of readmissions, which are often multifactorial in cause,” he said. Hospitalists are uniquely equipped to impact post-acute outcomes, Dr. Dickey said, working in partnership with a position Sound Physicians calls the clinical performance nurse.
“We can also partner with primary care providers, provide education for our hospitalist staff, and work with in-home care supports for patients such as these, who otherwise might end up in a skilled nursing facility – even though they’d rather be at home,” he said.
Innovations at Northwell Health
Northwell Health, a multihospital comprehensive health system serving the New York City metro area and Long Island, has shown innovative leadership in addressing social factors. The 23-hospital system initiated in early 2019 a 15-item Self-Reported Social Determinants Screening Tool, which is now used with hospitalized patients to connect them with the support they need to fully recover and avoid readmissions.
Northwell is also providing professional education on social determinants for different constituencies across its system, said Johanna Martinez, MD, MS, a hospitalist and GME Director of Diversity and Health Equity at the Zucker School of Medicine at Hofstra/Northwell. A day-long training retreat was offered to GME faculty, and learning platforms have been developed for physicians, social workers, nurses, and others.
“One of the questions that comes up is that if you find social needs, what do you do about them?” Dr. Martinez explained. That’s more a difficult challenge, she said, so at Northwell, orthopedic surgeons are now asking patients questions like: “What’s going to happen when you go home? What are your social supports? Can you get to the physical therapist’s office?”
Another example of Northwell’s innovations is its Food as Health Program, initially piloted at Long Island Jewish Hospital in Valley Stream, N.Y. Hospitalized patients are asked two questions using a validated screening tool called the Hunger Vital Sign to identify their food insecurities.8 Those who answer yes are referred to a dietitian, and if they have a nutrition-related diagnosis, they enter the multidisciplinary wraparound program.
A key element is the food and health center, located on the hospital campus, where they can get food to take home and referrals to other services, with culturally tailored, disease-specific food education incorporated into the discharge plan. One of the partnering organizations is Island Harvest Food Bank, which helps about 1 in every 10 residents of Long Island with their food insecurity issues.
“When I talk to clinicians, most of us went into medicine to save lives and cure people. Yet the research shows that no matter who we are, we can’t do the best work that our patients need unless we consider their social determinants,” Dr. Martinez said. Ultimately, she noted, there is a need to change the culture of health care. “We have to create system change, reimbursement change, policy change.”
Omolara Uwemedimo, MD, MPH, associate professor of pediatrics and occupational medicine at Northwell and a former nocturnist, said the treatment of illness and health improvement don’t begin in the hospital, they begin in the community. Identifying where people are struggling and what communities they come from requires a broader view of the provider’s role. “Are patients who are readmitted to the hospital generally coming from certain demographics or from certain zip codes?” she asked. “Start there. How can we better connect with those communities?”
Education is key
In 2020 and beyond, hospitalists will hear more about the social determinants of health, Dr. Jacobs-Shaw concluded. “Without addressing those social determinants, we aren’t going to be able to meaningfully impact outcomes or be effective stewards of health care costs – addressing the psychosocial factors and root causes of patients coming in and out of the hospital.”
He added that self-education is key for hospitalists and the teams they work with – to be more aware of the link between health outcomes and social determinants. Guidelines and other resources on social determinants of health are available from the American College of Physicians and the American Association of Family Physicians. ACP issued a position paper on addressing social determinants of health to improve patient care,while AAFP has a research page on its website dedicated to social determinants of health, highlighting a number of initiatives and resources for physicians and others.9
The American Hospital Association has produced fact sheets on ICD-10CM code categories for social determinants of health, including 11 ICD-10 “Z” codes, numbered Z55-Z65, which can be used for coding interventions to address social determinants of health. Other experts are looking at how to adapt the electronic health record to capture sociodemographic and behavioral factors, and then trigger referrals to resources in the hospital and the broader community, and how to mobilize artificial intelligence and machine learning to better identify social needs.
“Our doctors really want to be able to take care of the whole patient, while being stewards of health care resources. But sometimes we feel powerless and wonder how we can have a bigger impact on people, on populations” Dr. Jacobs-Shaw said. “Remember it only takes one voice within an organization to start to elevate this topic.”
References
1. Rappleye E. Physicians say social determinants of health are not their responsibility. Becker’s Hospital Review. 2018 May 15.
2. Robert Wood Johnson Foundation, University of Wisconsin Population Health Institute. County Health Rankings, 2014.
3. Freeman, GA. The extensivist model. Health Leaders Magazine, 2016 Sep 15.
4. Kind AJ et al. Neighborhood socioeconomic disadvantage and 30-day rehospitalization: A retrospective cohort study. Ann Intern Med. 2014 Dec 2;161(11):765-74.
5. National Institute for Health Care Management. Addressing social determinants of health can improve community health & reduce costs.
6. Vial PB. Boundless collaboration: A philosophy for sustainable and stabilizing housing investment strategies. Health Progress: Journal of the Catholic Health Association of the United States. September-October 2019.
7. Social determinants of health: New solutions for growing complexities. Op-Med, a blog by Sound Physicians. 2019 Aug 1.
8. The hunger vital sign: A new standard of care for preventive health.
9. Daniel H et al. Addressing social determinants to improve patient care and promote health equity: An American College of Physicians position paper. Ann Intern Med. 2018;168:557-578.
Large study probes colonoscopy surveillance intervals
In contrast, patients with high-risk adenomas at baseline had significantly elevated rates of both CRC and CRC-related death, reported lead author Jeffrey K. Lee, MD, of Kaiser Permanente San Francisco and colleagues.
With additional research, these findings may influence colonoscopy surveillance intervals, the investigators wrote in Gastroenterology.
“Current guidelines recommend that patients with a low-risk adenoma finding ... receive surveillance colonoscopy in 5-10 years, although in practice, clinicians often use even more frequent surveillance ... in this low-risk group,” they wrote. “The rationale for continued support of shorter-than-recommended surveillance intervals for patients with low-risk adenomas is unclear, but could stem from a lack of long-term population-based studies assessing colorectal cancer incidence and related deaths following low-risk adenoma removal or randomized trials evaluating optimal postpolypectomy surveillance intervals.”
To alleviate this knowledge gap, the investigators began by screening data from 186,046 patients who underwent baseline colonoscopy between 2004 and 2010 at 21 medical centers in California. Following exclusions based on family history, confounding gastrointestinal diseases, and incomplete data, 64,422 patients remained. Among these patients, the mean age was 61.6 years, with a slight female majority (54.3%). Almost three out of four patients (71.2%) had normal colonoscopy findings, followed by smaller proportions who were diagnosed with low-risk adenoma (17.0%) or high-risk adenoma (11.7%), based on United States Multi-Society Task Force guidelines.
After a median follow-up of 8.1 years, 117 patients who had normal colonoscopy findings developed CRC, 22 of whom died from the disease. In comparison, the low-risk adenoma group had 37 cases of CRC and 3 instances of CRC-related death, whereas the high-risk adenoma group had 60 cases of CRC and 13 instances of CRC-related death.
In the no-adenoma and low-risk groups, trends in age-adjusted CRC incidence rates were similar; in both cohorts, CRC incidence increased gradually over the decade following colonoscopy, with each group reaching approximately 50 cases per 100,000 person-years by year 10. In contrast, CRC incidence climbed rapidly in the high-risk adenoma group, ultimately peaking a decade later at almost 220 cases per 100,000 person-years. Average incidence rates per 100,000 person-years were similar among patients with no adenoma (31.1) and low-risk adenoma (38.8), but markedly higher among those with high-risk adenoma (90.8). At the end of the 14-year follow-up period, absolute risks of CRC among patients with no adenoma, low-risk adenoma, and high-risk adenoma were 0.51%, 0.57%, and 2.03%, respectively.
Based on covariate-adjusted Cox regression models, patients with low-risk adenoma did not have a significantly higher risk of CRC or CRC-related death than did patients with no adenoma. In contrast, patients with high-risk adenoma had significantly higher risks of CRC (hazard ratio, 2.61) and CRC-related death (HR, 3.94).
“These findings support guideline recommendations for intensive colonoscopy surveillance in [patients with high-risk adenomas at baseline],” the investigators wrote.
Considering similar risks between patients with low-risk adenomas and those with normal findings, the investigators suggested that longer surveillance intervals may be acceptable for both of these patient populations.
“Guidelines recommending comparable follow-up for low-risk adenomas and normal examinations, such as lengthening the surveillance interval to more than 5 years and possibly 10 years, may provide comparable cancer incidence and mortality benefits for these two groups,” they wrote.
Still, the investigators noted that study limitations – such as disparate rates of subsequent colonoscopy between groups – make it difficult to draw definitive, practice-changing conclusions.
“Additional studies, potentially including randomized trials, on the natural history of low-risk adenoma and normal findings without intervening surveillance exams before 10 years are needed to help guide future surveillance practices,” they concluded.
The study was supported by the National Cancer Institute and the American Gastroenterological Association. The investigators disclosed no conflicts of interest.
SOURCE: Lee JK et al. Gastroenterology. 2019 Oct 4. doi: 10.1053/j.gastro.2019.09.039.
Study strengths include a large sample and inclusion of quality measures such as adenoma detection rates. However, to examine conventional adenoma risk, individuals with serrated polyps were excluded and thus the impact of these lesions is unclear. Since New Hampshire Colonoscopy Registry data demonstrate a higher risk of metachronous advanced adenomas for those with both sessile serrated polyps and high-risk adenomas, long-term CRC data for serrated polyps is crucial. In addition, data from short-term studies suggest that there may be heterogeneity in risk for LRAs, a higher risk for an 8-mm lesion than a 3-mm one. Thus, we await more long-term studies to address these and other issues.
Joseph C. Anderson, MD, MHCDS, is an associate professor of medicine at White River Junction VAMC, Dartmouth College, Hanover, N.H., and the University of Connecticut Health Center, Farmington, Conn. The contents of this work do not represent the views of the Department of Veterans Affairs or the United States Government. He has no relevant conflicts of interest.
Study strengths include a large sample and inclusion of quality measures such as adenoma detection rates. However, to examine conventional adenoma risk, individuals with serrated polyps were excluded and thus the impact of these lesions is unclear. Since New Hampshire Colonoscopy Registry data demonstrate a higher risk of metachronous advanced adenomas for those with both sessile serrated polyps and high-risk adenomas, long-term CRC data for serrated polyps is crucial. In addition, data from short-term studies suggest that there may be heterogeneity in risk for LRAs, a higher risk for an 8-mm lesion than a 3-mm one. Thus, we await more long-term studies to address these and other issues.
Joseph C. Anderson, MD, MHCDS, is an associate professor of medicine at White River Junction VAMC, Dartmouth College, Hanover, N.H., and the University of Connecticut Health Center, Farmington, Conn. The contents of this work do not represent the views of the Department of Veterans Affairs or the United States Government. He has no relevant conflicts of interest.
Study strengths include a large sample and inclusion of quality measures such as adenoma detection rates. However, to examine conventional adenoma risk, individuals with serrated polyps were excluded and thus the impact of these lesions is unclear. Since New Hampshire Colonoscopy Registry data demonstrate a higher risk of metachronous advanced adenomas for those with both sessile serrated polyps and high-risk adenomas, long-term CRC data for serrated polyps is crucial. In addition, data from short-term studies suggest that there may be heterogeneity in risk for LRAs, a higher risk for an 8-mm lesion than a 3-mm one. Thus, we await more long-term studies to address these and other issues.
Joseph C. Anderson, MD, MHCDS, is an associate professor of medicine at White River Junction VAMC, Dartmouth College, Hanover, N.H., and the University of Connecticut Health Center, Farmington, Conn. The contents of this work do not represent the views of the Department of Veterans Affairs or the United States Government. He has no relevant conflicts of interest.
In contrast, patients with high-risk adenomas at baseline had significantly elevated rates of both CRC and CRC-related death, reported lead author Jeffrey K. Lee, MD, of Kaiser Permanente San Francisco and colleagues.
With additional research, these findings may influence colonoscopy surveillance intervals, the investigators wrote in Gastroenterology.
“Current guidelines recommend that patients with a low-risk adenoma finding ... receive surveillance colonoscopy in 5-10 years, although in practice, clinicians often use even more frequent surveillance ... in this low-risk group,” they wrote. “The rationale for continued support of shorter-than-recommended surveillance intervals for patients with low-risk adenomas is unclear, but could stem from a lack of long-term population-based studies assessing colorectal cancer incidence and related deaths following low-risk adenoma removal or randomized trials evaluating optimal postpolypectomy surveillance intervals.”
To alleviate this knowledge gap, the investigators began by screening data from 186,046 patients who underwent baseline colonoscopy between 2004 and 2010 at 21 medical centers in California. Following exclusions based on family history, confounding gastrointestinal diseases, and incomplete data, 64,422 patients remained. Among these patients, the mean age was 61.6 years, with a slight female majority (54.3%). Almost three out of four patients (71.2%) had normal colonoscopy findings, followed by smaller proportions who were diagnosed with low-risk adenoma (17.0%) or high-risk adenoma (11.7%), based on United States Multi-Society Task Force guidelines.
After a median follow-up of 8.1 years, 117 patients who had normal colonoscopy findings developed CRC, 22 of whom died from the disease. In comparison, the low-risk adenoma group had 37 cases of CRC and 3 instances of CRC-related death, whereas the high-risk adenoma group had 60 cases of CRC and 13 instances of CRC-related death.
In the no-adenoma and low-risk groups, trends in age-adjusted CRC incidence rates were similar; in both cohorts, CRC incidence increased gradually over the decade following colonoscopy, with each group reaching approximately 50 cases per 100,000 person-years by year 10. In contrast, CRC incidence climbed rapidly in the high-risk adenoma group, ultimately peaking a decade later at almost 220 cases per 100,000 person-years. Average incidence rates per 100,000 person-years were similar among patients with no adenoma (31.1) and low-risk adenoma (38.8), but markedly higher among those with high-risk adenoma (90.8). At the end of the 14-year follow-up period, absolute risks of CRC among patients with no adenoma, low-risk adenoma, and high-risk adenoma were 0.51%, 0.57%, and 2.03%, respectively.
Based on covariate-adjusted Cox regression models, patients with low-risk adenoma did not have a significantly higher risk of CRC or CRC-related death than did patients with no adenoma. In contrast, patients with high-risk adenoma had significantly higher risks of CRC (hazard ratio, 2.61) and CRC-related death (HR, 3.94).
“These findings support guideline recommendations for intensive colonoscopy surveillance in [patients with high-risk adenomas at baseline],” the investigators wrote.
Considering similar risks between patients with low-risk adenomas and those with normal findings, the investigators suggested that longer surveillance intervals may be acceptable for both of these patient populations.
“Guidelines recommending comparable follow-up for low-risk adenomas and normal examinations, such as lengthening the surveillance interval to more than 5 years and possibly 10 years, may provide comparable cancer incidence and mortality benefits for these two groups,” they wrote.
Still, the investigators noted that study limitations – such as disparate rates of subsequent colonoscopy between groups – make it difficult to draw definitive, practice-changing conclusions.
“Additional studies, potentially including randomized trials, on the natural history of low-risk adenoma and normal findings without intervening surveillance exams before 10 years are needed to help guide future surveillance practices,” they concluded.
The study was supported by the National Cancer Institute and the American Gastroenterological Association. The investigators disclosed no conflicts of interest.
SOURCE: Lee JK et al. Gastroenterology. 2019 Oct 4. doi: 10.1053/j.gastro.2019.09.039.
In contrast, patients with high-risk adenomas at baseline had significantly elevated rates of both CRC and CRC-related death, reported lead author Jeffrey K. Lee, MD, of Kaiser Permanente San Francisco and colleagues.
With additional research, these findings may influence colonoscopy surveillance intervals, the investigators wrote in Gastroenterology.
“Current guidelines recommend that patients with a low-risk adenoma finding ... receive surveillance colonoscopy in 5-10 years, although in practice, clinicians often use even more frequent surveillance ... in this low-risk group,” they wrote. “The rationale for continued support of shorter-than-recommended surveillance intervals for patients with low-risk adenomas is unclear, but could stem from a lack of long-term population-based studies assessing colorectal cancer incidence and related deaths following low-risk adenoma removal or randomized trials evaluating optimal postpolypectomy surveillance intervals.”
To alleviate this knowledge gap, the investigators began by screening data from 186,046 patients who underwent baseline colonoscopy between 2004 and 2010 at 21 medical centers in California. Following exclusions based on family history, confounding gastrointestinal diseases, and incomplete data, 64,422 patients remained. Among these patients, the mean age was 61.6 years, with a slight female majority (54.3%). Almost three out of four patients (71.2%) had normal colonoscopy findings, followed by smaller proportions who were diagnosed with low-risk adenoma (17.0%) or high-risk adenoma (11.7%), based on United States Multi-Society Task Force guidelines.
After a median follow-up of 8.1 years, 117 patients who had normal colonoscopy findings developed CRC, 22 of whom died from the disease. In comparison, the low-risk adenoma group had 37 cases of CRC and 3 instances of CRC-related death, whereas the high-risk adenoma group had 60 cases of CRC and 13 instances of CRC-related death.
In the no-adenoma and low-risk groups, trends in age-adjusted CRC incidence rates were similar; in both cohorts, CRC incidence increased gradually over the decade following colonoscopy, with each group reaching approximately 50 cases per 100,000 person-years by year 10. In contrast, CRC incidence climbed rapidly in the high-risk adenoma group, ultimately peaking a decade later at almost 220 cases per 100,000 person-years. Average incidence rates per 100,000 person-years were similar among patients with no adenoma (31.1) and low-risk adenoma (38.8), but markedly higher among those with high-risk adenoma (90.8). At the end of the 14-year follow-up period, absolute risks of CRC among patients with no adenoma, low-risk adenoma, and high-risk adenoma were 0.51%, 0.57%, and 2.03%, respectively.
Based on covariate-adjusted Cox regression models, patients with low-risk adenoma did not have a significantly higher risk of CRC or CRC-related death than did patients with no adenoma. In contrast, patients with high-risk adenoma had significantly higher risks of CRC (hazard ratio, 2.61) and CRC-related death (HR, 3.94).
“These findings support guideline recommendations for intensive colonoscopy surveillance in [patients with high-risk adenomas at baseline],” the investigators wrote.
Considering similar risks between patients with low-risk adenomas and those with normal findings, the investigators suggested that longer surveillance intervals may be acceptable for both of these patient populations.
“Guidelines recommending comparable follow-up for low-risk adenomas and normal examinations, such as lengthening the surveillance interval to more than 5 years and possibly 10 years, may provide comparable cancer incidence and mortality benefits for these two groups,” they wrote.
Still, the investigators noted that study limitations – such as disparate rates of subsequent colonoscopy between groups – make it difficult to draw definitive, practice-changing conclusions.
“Additional studies, potentially including randomized trials, on the natural history of low-risk adenoma and normal findings without intervening surveillance exams before 10 years are needed to help guide future surveillance practices,” they concluded.
The study was supported by the National Cancer Institute and the American Gastroenterological Association. The investigators disclosed no conflicts of interest.
SOURCE: Lee JK et al. Gastroenterology. 2019 Oct 4. doi: 10.1053/j.gastro.2019.09.039.
FROM GASTROENTEROLOGY
Key clinical point: High-risk adenomas, but not low-risk adenomas, are associated with increased long-term risks of colorectal cancer (CRC) and CRC-related death.
Major finding: Compared with patients without adenomas, patients diagnosed with high-risk adenoma had a significantly increased risk of colorectal cancer (hazard ratio, 2.61).
Study details: A retrospective cohort study involving 64,422 patients who underwent colonoscopy between 2004 and 2010.
Disclosures: The study was supported by the National Cancer Institute and the American Gastroenterological Association. The investigators disclosed no conflicts of interest.
Source: Lee JK et al. Gastroenterology. 2019 Oct 4. doi: 10.1053/j.gastro.2019.09.039.
Radioactive iodine can be first-line for hyperthyroidism, says UK
New UK guidelines for the treatment of hyperthyroidism, including Graves’ disease, place heavier emphasis on the use of radioactive iodine as the frontline treatment for patients unlikely to remain remission-free on the medications, as opposed to the alternative of antithyroid medications as a first choice.
senior author Kristien Boelaert, MD, PhD, who led the guideline committee, said in an interview.
“Recommending the use of radioactive iodine as first-line treatment for adults with Graves’ disease is a change to current practice and should reduce the variation between centers as to when radioactive iodine is considered appropriate,” the guidelines further state.
The new recommendations on hyperthyroidism are part of broader guidelines on thyroid disease by the UK National Institute for Health and Care Excellence (NICE), which concludes that radioactive iodine results in cure in as many as 90% of hyperthyroidism cases.
The recommendations were published in a guideline summary in BMJ by research fellow Melina Vasileiou of the National Guideline Centre, Royal College of Physicians, London, and colleagues.
Current guidelines in the United Kingdom and Europe typically call for radioactive iodine to be reserved for use as a definitive treatment only after relapse following antithyroid medication treatment. The latest European Thyroid Association guidelines were published in 2018.
Elsewhere guidelines vary, with many, including those by the American Thyroid Association (ATA) – the most recent published in 2016 – generally calling for treatment with either antithyroid medications, radioactive iodine, or total thyroidectomy, in the absence of any contraindications to each treatment option.
“The U.S. tends to use more radioactive iodine, while Europe, Latin America, and Japan lean more toward (perhaps longer) use of antithyroid medications,” Angela Leung, MD, associate clinical professor of medicine in the division of endocrinology, diabetes, and metabolism, department of medicine, University of California, Los Angeles, said in an interview.
“Preferences of deciding which treatment option, which may involve more than one option if antithyroid medications are used initially, depend on a variety of factors related to patient desire, comorbidities, and availability of the therapy,” she explained.
Concerns including worsening thyroid eye disease, cardiovascular disease, and development of secondary cancers have caused some hesitation in the use of frontline radioiodine therapy.
And one notably controversial article, published last year, suggested a link between radioactive iodine therapy and an increased risk of cancer mortality. However, as reported by Medscape Medical News, the article spurred debate, with the Society for Endocrinology and British Thyroid Association issuing a joint statement urging caution in interpretation of the findings.
Evidence supporting first-line radioactive iodine
Patients treated with radioactive iodine take a single tablet that contains iodine and a low dose of radiation, which is absorbed by the thyroid. After taking the treatment patients are advised to avoid prolonged close contact with children and pregnant women for a few days or weeks and to avoid getting pregnant or fathering a child for several months. The treatment is likely to lead to an underactive thyroid gland that will require ongoing treatment with thyroid hormone replacement.
In providing evidence in favor of the benefits of radioactive iodine over the risks, the new NICE guidelines cite five randomized controlled trials of people with hyperthyroid disease, which, though defined as “low quality” evidence, collectively indicate that long-term outcomes were improved with radioactive iodine treatment compared with antithyroid drugs – despite the former having a higher risk of thyroid eye disease (also known as Graves’ ophthalmopathy).
In addition, eight nonrandomized studies show no evidence of a clinically important increase in cancer diagnoses or deaths between people treated with radioactive iodine or surgery, or between people treated with radioactive iodine and healthy controls, the guideline committee notes.
“The strongest arguments (in favor of radioactive iodine as a first-line therapy) were the likelihood of inducing remission of Graves’ disease with radioactive iodine, the finding that radioiodine is a safe treatment (confirmed in the safety review undertaken by NICE), and the reduction in the need for patients to remain on antithyroid drugs, which may have significant side effects and treatment which usually requires repeated hospital visits or follow-up under a hospital service,” said Dr. Boelaert.
The new guideline does recommend that antithyroid medication is acceptable as the first-line treatment among patients considered likely to achieve remission.
Dr. Leung explains that the percentage of patients with Graves’ disease who can achieve remission with antithyroid drugs ranges from 30% to 50%. She noted some evidence does suggest the long-term use of the drugs may be acceptable.
“There are some data that ... report the relative safety of long-term use of antithyroid drugs (beyond 24 months) for both Graves’ disease and autonomous thyroid nodules,” Dr. Leung elaborated.
Pregnancy concerns and cost-effectiveness of radioactive iodine
Radioactive iodine therapy is meanwhile not suitable if malignancy is suspected, if the patient is pregnant or trying to become pregnant, or if the patient has active thyroid eye disease, the experts agree.
Dr. Leung noted that although “it is generally advised to not treat Graves’ disease with radioiodine if there is concurrent thyroid eye disease, steroids are a proven effective therapy to decrease this risk in select patients.”
And among pregnant patients, “antithyroid medications should be minimally used in the lowest possible doses,” Dr. Leung said, although she added that, despite their potential risks, the drugs “represent a viable option” for this patient population.
“Also, many would actually advocate for total thyroidectomy in women who are thinking of pregnancy in the near future,” she noted.
Another factor of relevance in the guideline recommendations – cost – also favors radioactive iodine, the committee noted.
“Economic evidence showed that radioactive iodine was the most cost-effective intervention,” the committee pointed out.
Trabs advised for determination of hyperthyroidism cause
The new U.K. guidelines further underscore the importance of establishing the underlying cause of hyperthyroidism to ensure appropriate treatment, and the preferred method for doing so is the measurement of thyroid-stimulating hormone receptor antibodies (TRAbs).
“It is important to identify the underlying cause of thyrotoxicosis through measurement of TRAbs, or radioisotope scanning, in order to distinguish hyperthyroidism from transient causes of thyrotoxicosis such as transient thyroiditis, which only requires supportive treatment,” explained Dr. Boelaert, consultant endocrinologist and director of the National Institute for Health Research Integrated Academic Training Program at the Institute of Applied Health Research, University of Birmingham (England).
“In addition, this will help distinguish Graves’ disease from toxic nodular hyperthyroidism, which is important as antithyroid drugs are not effective in inducing a cure in the latter,” she explained.
Meanwhile, the new guidelines further note that although use of diagnostic ultrasound is informative when palpation suggests thyroid nodules, it is of limited diagnostic value for Graves’ disease.
“The recommendation (suggests that) thyroid ultrasonography should only be offered if there is a palpable thyroid nodule,” Dr. Boelaert noted.
She concluded: “There has been uncertainty in the U.K. about the best treatment for hyperthyroidism despite radioactive iodine being the most common first-line treatment for this condition in the United States. We are very pleased to have been able to work with NICE to provide clear new guidance which we hope will improve outcomes for patients with this condition.”
The National Guideline Centre was commissioned and funded by NICE to develop the guideline. No authors received specific funding to write the summary. Dr. Boelaert has reported no relevant financial relationships. Disclosures for the other authors are listed in the article.
This article first appeared on Medscape.com.
New UK guidelines for the treatment of hyperthyroidism, including Graves’ disease, place heavier emphasis on the use of radioactive iodine as the frontline treatment for patients unlikely to remain remission-free on the medications, as opposed to the alternative of antithyroid medications as a first choice.
senior author Kristien Boelaert, MD, PhD, who led the guideline committee, said in an interview.
“Recommending the use of radioactive iodine as first-line treatment for adults with Graves’ disease is a change to current practice and should reduce the variation between centers as to when radioactive iodine is considered appropriate,” the guidelines further state.
The new recommendations on hyperthyroidism are part of broader guidelines on thyroid disease by the UK National Institute for Health and Care Excellence (NICE), which concludes that radioactive iodine results in cure in as many as 90% of hyperthyroidism cases.
The recommendations were published in a guideline summary in BMJ by research fellow Melina Vasileiou of the National Guideline Centre, Royal College of Physicians, London, and colleagues.
Current guidelines in the United Kingdom and Europe typically call for radioactive iodine to be reserved for use as a definitive treatment only after relapse following antithyroid medication treatment. The latest European Thyroid Association guidelines were published in 2018.
Elsewhere guidelines vary, with many, including those by the American Thyroid Association (ATA) – the most recent published in 2016 – generally calling for treatment with either antithyroid medications, radioactive iodine, or total thyroidectomy, in the absence of any contraindications to each treatment option.
“The U.S. tends to use more radioactive iodine, while Europe, Latin America, and Japan lean more toward (perhaps longer) use of antithyroid medications,” Angela Leung, MD, associate clinical professor of medicine in the division of endocrinology, diabetes, and metabolism, department of medicine, University of California, Los Angeles, said in an interview.
“Preferences of deciding which treatment option, which may involve more than one option if antithyroid medications are used initially, depend on a variety of factors related to patient desire, comorbidities, and availability of the therapy,” she explained.
Concerns including worsening thyroid eye disease, cardiovascular disease, and development of secondary cancers have caused some hesitation in the use of frontline radioiodine therapy.
And one notably controversial article, published last year, suggested a link between radioactive iodine therapy and an increased risk of cancer mortality. However, as reported by Medscape Medical News, the article spurred debate, with the Society for Endocrinology and British Thyroid Association issuing a joint statement urging caution in interpretation of the findings.
Evidence supporting first-line radioactive iodine
Patients treated with radioactive iodine take a single tablet that contains iodine and a low dose of radiation, which is absorbed by the thyroid. After taking the treatment patients are advised to avoid prolonged close contact with children and pregnant women for a few days or weeks and to avoid getting pregnant or fathering a child for several months. The treatment is likely to lead to an underactive thyroid gland that will require ongoing treatment with thyroid hormone replacement.
In providing evidence in favor of the benefits of radioactive iodine over the risks, the new NICE guidelines cite five randomized controlled trials of people with hyperthyroid disease, which, though defined as “low quality” evidence, collectively indicate that long-term outcomes were improved with radioactive iodine treatment compared with antithyroid drugs – despite the former having a higher risk of thyroid eye disease (also known as Graves’ ophthalmopathy).
In addition, eight nonrandomized studies show no evidence of a clinically important increase in cancer diagnoses or deaths between people treated with radioactive iodine or surgery, or between people treated with radioactive iodine and healthy controls, the guideline committee notes.
“The strongest arguments (in favor of radioactive iodine as a first-line therapy) were the likelihood of inducing remission of Graves’ disease with radioactive iodine, the finding that radioiodine is a safe treatment (confirmed in the safety review undertaken by NICE), and the reduction in the need for patients to remain on antithyroid drugs, which may have significant side effects and treatment which usually requires repeated hospital visits or follow-up under a hospital service,” said Dr. Boelaert.
The new guideline does recommend that antithyroid medication is acceptable as the first-line treatment among patients considered likely to achieve remission.
Dr. Leung explains that the percentage of patients with Graves’ disease who can achieve remission with antithyroid drugs ranges from 30% to 50%. She noted some evidence does suggest the long-term use of the drugs may be acceptable.
“There are some data that ... report the relative safety of long-term use of antithyroid drugs (beyond 24 months) for both Graves’ disease and autonomous thyroid nodules,” Dr. Leung elaborated.
Pregnancy concerns and cost-effectiveness of radioactive iodine
Radioactive iodine therapy is meanwhile not suitable if malignancy is suspected, if the patient is pregnant or trying to become pregnant, or if the patient has active thyroid eye disease, the experts agree.
Dr. Leung noted that although “it is generally advised to not treat Graves’ disease with radioiodine if there is concurrent thyroid eye disease, steroids are a proven effective therapy to decrease this risk in select patients.”
And among pregnant patients, “antithyroid medications should be minimally used in the lowest possible doses,” Dr. Leung said, although she added that, despite their potential risks, the drugs “represent a viable option” for this patient population.
“Also, many would actually advocate for total thyroidectomy in women who are thinking of pregnancy in the near future,” she noted.
Another factor of relevance in the guideline recommendations – cost – also favors radioactive iodine, the committee noted.
“Economic evidence showed that radioactive iodine was the most cost-effective intervention,” the committee pointed out.
Trabs advised for determination of hyperthyroidism cause
The new U.K. guidelines further underscore the importance of establishing the underlying cause of hyperthyroidism to ensure appropriate treatment, and the preferred method for doing so is the measurement of thyroid-stimulating hormone receptor antibodies (TRAbs).
“It is important to identify the underlying cause of thyrotoxicosis through measurement of TRAbs, or radioisotope scanning, in order to distinguish hyperthyroidism from transient causes of thyrotoxicosis such as transient thyroiditis, which only requires supportive treatment,” explained Dr. Boelaert, consultant endocrinologist and director of the National Institute for Health Research Integrated Academic Training Program at the Institute of Applied Health Research, University of Birmingham (England).
“In addition, this will help distinguish Graves’ disease from toxic nodular hyperthyroidism, which is important as antithyroid drugs are not effective in inducing a cure in the latter,” she explained.
Meanwhile, the new guidelines further note that although use of diagnostic ultrasound is informative when palpation suggests thyroid nodules, it is of limited diagnostic value for Graves’ disease.
“The recommendation (suggests that) thyroid ultrasonography should only be offered if there is a palpable thyroid nodule,” Dr. Boelaert noted.
She concluded: “There has been uncertainty in the U.K. about the best treatment for hyperthyroidism despite radioactive iodine being the most common first-line treatment for this condition in the United States. We are very pleased to have been able to work with NICE to provide clear new guidance which we hope will improve outcomes for patients with this condition.”
The National Guideline Centre was commissioned and funded by NICE to develop the guideline. No authors received specific funding to write the summary. Dr. Boelaert has reported no relevant financial relationships. Disclosures for the other authors are listed in the article.
This article first appeared on Medscape.com.
New UK guidelines for the treatment of hyperthyroidism, including Graves’ disease, place heavier emphasis on the use of radioactive iodine as the frontline treatment for patients unlikely to remain remission-free on the medications, as opposed to the alternative of antithyroid medications as a first choice.
senior author Kristien Boelaert, MD, PhD, who led the guideline committee, said in an interview.
“Recommending the use of radioactive iodine as first-line treatment for adults with Graves’ disease is a change to current practice and should reduce the variation between centers as to when radioactive iodine is considered appropriate,” the guidelines further state.
The new recommendations on hyperthyroidism are part of broader guidelines on thyroid disease by the UK National Institute for Health and Care Excellence (NICE), which concludes that radioactive iodine results in cure in as many as 90% of hyperthyroidism cases.
The recommendations were published in a guideline summary in BMJ by research fellow Melina Vasileiou of the National Guideline Centre, Royal College of Physicians, London, and colleagues.
Current guidelines in the United Kingdom and Europe typically call for radioactive iodine to be reserved for use as a definitive treatment only after relapse following antithyroid medication treatment. The latest European Thyroid Association guidelines were published in 2018.
Elsewhere guidelines vary, with many, including those by the American Thyroid Association (ATA) – the most recent published in 2016 – generally calling for treatment with either antithyroid medications, radioactive iodine, or total thyroidectomy, in the absence of any contraindications to each treatment option.
“The U.S. tends to use more radioactive iodine, while Europe, Latin America, and Japan lean more toward (perhaps longer) use of antithyroid medications,” Angela Leung, MD, associate clinical professor of medicine in the division of endocrinology, diabetes, and metabolism, department of medicine, University of California, Los Angeles, said in an interview.
“Preferences of deciding which treatment option, which may involve more than one option if antithyroid medications are used initially, depend on a variety of factors related to patient desire, comorbidities, and availability of the therapy,” she explained.
Concerns including worsening thyroid eye disease, cardiovascular disease, and development of secondary cancers have caused some hesitation in the use of frontline radioiodine therapy.
And one notably controversial article, published last year, suggested a link between radioactive iodine therapy and an increased risk of cancer mortality. However, as reported by Medscape Medical News, the article spurred debate, with the Society for Endocrinology and British Thyroid Association issuing a joint statement urging caution in interpretation of the findings.
Evidence supporting first-line radioactive iodine
Patients treated with radioactive iodine take a single tablet that contains iodine and a low dose of radiation, which is absorbed by the thyroid. After taking the treatment patients are advised to avoid prolonged close contact with children and pregnant women for a few days or weeks and to avoid getting pregnant or fathering a child for several months. The treatment is likely to lead to an underactive thyroid gland that will require ongoing treatment with thyroid hormone replacement.
In providing evidence in favor of the benefits of radioactive iodine over the risks, the new NICE guidelines cite five randomized controlled trials of people with hyperthyroid disease, which, though defined as “low quality” evidence, collectively indicate that long-term outcomes were improved with radioactive iodine treatment compared with antithyroid drugs – despite the former having a higher risk of thyroid eye disease (also known as Graves’ ophthalmopathy).
In addition, eight nonrandomized studies show no evidence of a clinically important increase in cancer diagnoses or deaths between people treated with radioactive iodine or surgery, or between people treated with radioactive iodine and healthy controls, the guideline committee notes.
“The strongest arguments (in favor of radioactive iodine as a first-line therapy) were the likelihood of inducing remission of Graves’ disease with radioactive iodine, the finding that radioiodine is a safe treatment (confirmed in the safety review undertaken by NICE), and the reduction in the need for patients to remain on antithyroid drugs, which may have significant side effects and treatment which usually requires repeated hospital visits or follow-up under a hospital service,” said Dr. Boelaert.
The new guideline does recommend that antithyroid medication is acceptable as the first-line treatment among patients considered likely to achieve remission.
Dr. Leung explains that the percentage of patients with Graves’ disease who can achieve remission with antithyroid drugs ranges from 30% to 50%. She noted some evidence does suggest the long-term use of the drugs may be acceptable.
“There are some data that ... report the relative safety of long-term use of antithyroid drugs (beyond 24 months) for both Graves’ disease and autonomous thyroid nodules,” Dr. Leung elaborated.
Pregnancy concerns and cost-effectiveness of radioactive iodine
Radioactive iodine therapy is meanwhile not suitable if malignancy is suspected, if the patient is pregnant or trying to become pregnant, or if the patient has active thyroid eye disease, the experts agree.
Dr. Leung noted that although “it is generally advised to not treat Graves’ disease with radioiodine if there is concurrent thyroid eye disease, steroids are a proven effective therapy to decrease this risk in select patients.”
And among pregnant patients, “antithyroid medications should be minimally used in the lowest possible doses,” Dr. Leung said, although she added that, despite their potential risks, the drugs “represent a viable option” for this patient population.
“Also, many would actually advocate for total thyroidectomy in women who are thinking of pregnancy in the near future,” she noted.
Another factor of relevance in the guideline recommendations – cost – also favors radioactive iodine, the committee noted.
“Economic evidence showed that radioactive iodine was the most cost-effective intervention,” the committee pointed out.
Trabs advised for determination of hyperthyroidism cause
The new U.K. guidelines further underscore the importance of establishing the underlying cause of hyperthyroidism to ensure appropriate treatment, and the preferred method for doing so is the measurement of thyroid-stimulating hormone receptor antibodies (TRAbs).
“It is important to identify the underlying cause of thyrotoxicosis through measurement of TRAbs, or radioisotope scanning, in order to distinguish hyperthyroidism from transient causes of thyrotoxicosis such as transient thyroiditis, which only requires supportive treatment,” explained Dr. Boelaert, consultant endocrinologist and director of the National Institute for Health Research Integrated Academic Training Program at the Institute of Applied Health Research, University of Birmingham (England).
“In addition, this will help distinguish Graves’ disease from toxic nodular hyperthyroidism, which is important as antithyroid drugs are not effective in inducing a cure in the latter,” she explained.
Meanwhile, the new guidelines further note that although use of diagnostic ultrasound is informative when palpation suggests thyroid nodules, it is of limited diagnostic value for Graves’ disease.
“The recommendation (suggests that) thyroid ultrasonography should only be offered if there is a palpable thyroid nodule,” Dr. Boelaert noted.
She concluded: “There has been uncertainty in the U.K. about the best treatment for hyperthyroidism despite radioactive iodine being the most common first-line treatment for this condition in the United States. We are very pleased to have been able to work with NICE to provide clear new guidance which we hope will improve outcomes for patients with this condition.”
The National Guideline Centre was commissioned and funded by NICE to develop the guideline. No authors received specific funding to write the summary. Dr. Boelaert has reported no relevant financial relationships. Disclosures for the other authors are listed in the article.
This article first appeared on Medscape.com.
Consider allergic contact dermatitis in children with AD with disease flares, new rash
ORLANDO – Do you have ? Consider patch testing to assess whether they have allergic contact dermatitis.
“Of the patients who are sent to me by local pediatric dermatologists, 50% of them are positive” for allergens, said Jonathan H. Zippin, MD, PhD, director of the contact, occupational, and photodermatitis service at Cornell University, New York.
Speaking at the ODAC Dermatology, Aesthetic, and Surgical Conference, Dr. Zippin noted the prevalence of allergen sensitization is between 13% and 25% among children who are asymptomatic, while the prevalence of sensitization to at least one allergen among children with suspected allergic contact dermatitis (ACD) is between 25% and 96%. In 2014, a study from the National American Contact Dermatitis Group (NACDG) showed that of 883 children who were patch tested, 56.7% had at least one relevant positive patch test (RPPT) result.
“The take-home message here is that pediatric contact dermatitis is common, much more common than a lot of people realize,” Dr. Zippin said.
He described three common scenarios to keep in mind: a worsening rash, a new rash, and failure of a rash to improve after the patient avoids all of his or her positive allergens.
When a rash worsens, patch testing is likely to offer answers. In an analysis of 1,142 patients with suspected ACD aged 18 years or younger (mean age, 10.5 years; 64% female) in the Pediatric Contact Dermatitis Registry study database, 65% had at least one positive patch test, and 48% had at least 1 RPPT (Dermatitis 2016; 27[5] 293-302).
But not all patch testing is the same: The study also found that 24% of the RPPT cases would have been missed if assessed with the T.R.U.E. TEST compared with extended patch testing. If a T.R.U.E. TEST fails to explain generalized atopic dermatitis, the patient should be sent for more comprehensive testing where available, Dr. Zippin advised.
Pediatric patients also have unique allergens clinicians should consider. In the same study, children had a number of allergens similar to those of adults as reported in previous studies, such as nickel, cobalt, and neomycin. However, propylene glycol and cocamidopropyl betaine were allergens identified as unique to the pediatric population.
Another study looking at the same group of patients found that compared with children who did not have AD, children with AD had 7.4 times higher odds of having an RPPT to cocamidopropyl betaine, 7.6 times higher odds of having an RPPT to parthenolide, 5.3 times higher odds of having an RPPT to tixocortol pivalate, 4.2 times higher odds of having an RPPT to wool alcohols, and 4 times higher odds of having an RPPT to lanolin (JAMA Dermatology 2017;153[8]:765-70).
All of these are components of topical medicaments used to treat AD, “either components of emollients that we recommend, or components of steroids that we recommend,” Dr. Zippin pointed out.
One of these allergens could be the culprit when a child develops a new rash but there are no new apparent changes in products, exposures, and activities. Lanolin, also called wool grease, is used in many skin care products, for example. Dr. Zippin described the case of a 6-year-old girl with a history of AD, who presented with a new rash on her scalp and behind her ears, not explained by any obvious changes to products, exposures, or activities. Subsequent patch testing determined that the rash was caused by baby shampoo, which contained cocamidopropyl betaine, which is used in hypoallergenic products. The rash resolved after a different shampoo was used.
“Sometimes, we really have to be thinking when the rash is getting worse, is there something they’re being exposed to that might be an allergen?” Dr. Zippin said.
In patients who have avoided all their positive allergens but a rash has not improved, clinicians should consider systemic contact dermatitis (SCD). Patients can develop SCD through different types of exposures, including transepidermal, transmucosal, oral, intravenous, subcutaneous, intramuscular, inhalation, and implantation routes.
SCD also has a variety of presentations, including pompholyx/dyshidrosis/vesicular dermatitis, maculopapular eruption, chronic pruritus, exfoliative erythroderma/toxiderma, chronic urticaria, erythema multiforme and vasculitis, hyperkeratotic papules of the elbows, acute generalized exanthematous pustulosis, and pruritus ani, according to Dr. Zippin.
SCD should be considered when a patient has a positive patch test to an allergen that is known to cause SCD, and does not clear after avoiding cutaneous exposure to the allergen, Dr. Zippin advised.
Patients will most often develop SCD from plants and herbs, Dr. Zippin noted. Chrysanthemums and chamomile tea are common culprits for compositae allergy and can trigger SCD; other causes are Anacardiaceae, Balsam of Peru, and propolis. Metals (nickel, cobalt, gold, and chromium), medications (aminoglycosides, corticosteroids, and ethylenediamine), and other sources (formaldehyde, propylene glycol in frozen foods, gallates, and methylisothiazolinone) can cause SCD as well.
Methylisothiazolinone in particular is a very common sensitizer, Dr. Zippin said. “If you have a patient who is positive to this, it’s almost always the cause of their problem.”
Balsam of Peru is in a number of different foods, and patients who need to follow a diet free of Balsam of Peru should avoid a long list of foods including citrus; bakery goods; Danish pastry; candy; gum; spices such as cinnamon, cloves, vanilla, curry, allspice, anise, and ginger; spicy condiments such as ketchup, chili sauce, barbecue sauce; chili, pizza, and foods with red sauces; tomatoes; pickles; alcohol (wine, beer, gin, vermouth); tea (perfumed or flavored); tobacco; chocolate and ice cream; and soft drinks (cola or spiced soft drinks).
Patients starting a nickel-free diet should avoid soy, peanuts and other nuts, legumes, chocolate, cocoa, oats, fish, and whole wheat flours. Any elimination diet should last for 3 months but should at least be tried for 3-4 weeks, with gradual reintroduction of foods suspected as triggers once per week. Any type I allergies that are discovered or suspected can be referred to an allergist for allergen challenge and desensitization therapy.
For more information, Dr. Zippin recommended the American Contact Dermatitis Society website for more information.
Dr. Zippin reported that he is the founder and holds stock options at CEP Biotech; is on the medical advisory board and receives stock options from YouV Labs., is a paid consultant and performs industry-sponsored research for Pfizer, receives stock options from Regeneron, and is on the medical advisory board for Hoth Therapeutics Inc. He is on the board of directors for the American Contact Dermatitis Society.
ORLANDO – Do you have ? Consider patch testing to assess whether they have allergic contact dermatitis.
“Of the patients who are sent to me by local pediatric dermatologists, 50% of them are positive” for allergens, said Jonathan H. Zippin, MD, PhD, director of the contact, occupational, and photodermatitis service at Cornell University, New York.
Speaking at the ODAC Dermatology, Aesthetic, and Surgical Conference, Dr. Zippin noted the prevalence of allergen sensitization is between 13% and 25% among children who are asymptomatic, while the prevalence of sensitization to at least one allergen among children with suspected allergic contact dermatitis (ACD) is between 25% and 96%. In 2014, a study from the National American Contact Dermatitis Group (NACDG) showed that of 883 children who were patch tested, 56.7% had at least one relevant positive patch test (RPPT) result.
“The take-home message here is that pediatric contact dermatitis is common, much more common than a lot of people realize,” Dr. Zippin said.
He described three common scenarios to keep in mind: a worsening rash, a new rash, and failure of a rash to improve after the patient avoids all of his or her positive allergens.
When a rash worsens, patch testing is likely to offer answers. In an analysis of 1,142 patients with suspected ACD aged 18 years or younger (mean age, 10.5 years; 64% female) in the Pediatric Contact Dermatitis Registry study database, 65% had at least one positive patch test, and 48% had at least 1 RPPT (Dermatitis 2016; 27[5] 293-302).
But not all patch testing is the same: The study also found that 24% of the RPPT cases would have been missed if assessed with the T.R.U.E. TEST compared with extended patch testing. If a T.R.U.E. TEST fails to explain generalized atopic dermatitis, the patient should be sent for more comprehensive testing where available, Dr. Zippin advised.
Pediatric patients also have unique allergens clinicians should consider. In the same study, children had a number of allergens similar to those of adults as reported in previous studies, such as nickel, cobalt, and neomycin. However, propylene glycol and cocamidopropyl betaine were allergens identified as unique to the pediatric population.
Another study looking at the same group of patients found that compared with children who did not have AD, children with AD had 7.4 times higher odds of having an RPPT to cocamidopropyl betaine, 7.6 times higher odds of having an RPPT to parthenolide, 5.3 times higher odds of having an RPPT to tixocortol pivalate, 4.2 times higher odds of having an RPPT to wool alcohols, and 4 times higher odds of having an RPPT to lanolin (JAMA Dermatology 2017;153[8]:765-70).
All of these are components of topical medicaments used to treat AD, “either components of emollients that we recommend, or components of steroids that we recommend,” Dr. Zippin pointed out.
One of these allergens could be the culprit when a child develops a new rash but there are no new apparent changes in products, exposures, and activities. Lanolin, also called wool grease, is used in many skin care products, for example. Dr. Zippin described the case of a 6-year-old girl with a history of AD, who presented with a new rash on her scalp and behind her ears, not explained by any obvious changes to products, exposures, or activities. Subsequent patch testing determined that the rash was caused by baby shampoo, which contained cocamidopropyl betaine, which is used in hypoallergenic products. The rash resolved after a different shampoo was used.
“Sometimes, we really have to be thinking when the rash is getting worse, is there something they’re being exposed to that might be an allergen?” Dr. Zippin said.
In patients who have avoided all their positive allergens but a rash has not improved, clinicians should consider systemic contact dermatitis (SCD). Patients can develop SCD through different types of exposures, including transepidermal, transmucosal, oral, intravenous, subcutaneous, intramuscular, inhalation, and implantation routes.
SCD also has a variety of presentations, including pompholyx/dyshidrosis/vesicular dermatitis, maculopapular eruption, chronic pruritus, exfoliative erythroderma/toxiderma, chronic urticaria, erythema multiforme and vasculitis, hyperkeratotic papules of the elbows, acute generalized exanthematous pustulosis, and pruritus ani, according to Dr. Zippin.
SCD should be considered when a patient has a positive patch test to an allergen that is known to cause SCD, and does not clear after avoiding cutaneous exposure to the allergen, Dr. Zippin advised.
Patients will most often develop SCD from plants and herbs, Dr. Zippin noted. Chrysanthemums and chamomile tea are common culprits for compositae allergy and can trigger SCD; other causes are Anacardiaceae, Balsam of Peru, and propolis. Metals (nickel, cobalt, gold, and chromium), medications (aminoglycosides, corticosteroids, and ethylenediamine), and other sources (formaldehyde, propylene glycol in frozen foods, gallates, and methylisothiazolinone) can cause SCD as well.
Methylisothiazolinone in particular is a very common sensitizer, Dr. Zippin said. “If you have a patient who is positive to this, it’s almost always the cause of their problem.”
Balsam of Peru is in a number of different foods, and patients who need to follow a diet free of Balsam of Peru should avoid a long list of foods including citrus; bakery goods; Danish pastry; candy; gum; spices such as cinnamon, cloves, vanilla, curry, allspice, anise, and ginger; spicy condiments such as ketchup, chili sauce, barbecue sauce; chili, pizza, and foods with red sauces; tomatoes; pickles; alcohol (wine, beer, gin, vermouth); tea (perfumed or flavored); tobacco; chocolate and ice cream; and soft drinks (cola or spiced soft drinks).
Patients starting a nickel-free diet should avoid soy, peanuts and other nuts, legumes, chocolate, cocoa, oats, fish, and whole wheat flours. Any elimination diet should last for 3 months but should at least be tried for 3-4 weeks, with gradual reintroduction of foods suspected as triggers once per week. Any type I allergies that are discovered or suspected can be referred to an allergist for allergen challenge and desensitization therapy.
For more information, Dr. Zippin recommended the American Contact Dermatitis Society website for more information.
Dr. Zippin reported that he is the founder and holds stock options at CEP Biotech; is on the medical advisory board and receives stock options from YouV Labs., is a paid consultant and performs industry-sponsored research for Pfizer, receives stock options from Regeneron, and is on the medical advisory board for Hoth Therapeutics Inc. He is on the board of directors for the American Contact Dermatitis Society.
ORLANDO – Do you have ? Consider patch testing to assess whether they have allergic contact dermatitis.
“Of the patients who are sent to me by local pediatric dermatologists, 50% of them are positive” for allergens, said Jonathan H. Zippin, MD, PhD, director of the contact, occupational, and photodermatitis service at Cornell University, New York.
Speaking at the ODAC Dermatology, Aesthetic, and Surgical Conference, Dr. Zippin noted the prevalence of allergen sensitization is between 13% and 25% among children who are asymptomatic, while the prevalence of sensitization to at least one allergen among children with suspected allergic contact dermatitis (ACD) is between 25% and 96%. In 2014, a study from the National American Contact Dermatitis Group (NACDG) showed that of 883 children who were patch tested, 56.7% had at least one relevant positive patch test (RPPT) result.
“The take-home message here is that pediatric contact dermatitis is common, much more common than a lot of people realize,” Dr. Zippin said.
He described three common scenarios to keep in mind: a worsening rash, a new rash, and failure of a rash to improve after the patient avoids all of his or her positive allergens.
When a rash worsens, patch testing is likely to offer answers. In an analysis of 1,142 patients with suspected ACD aged 18 years or younger (mean age, 10.5 years; 64% female) in the Pediatric Contact Dermatitis Registry study database, 65% had at least one positive patch test, and 48% had at least 1 RPPT (Dermatitis 2016; 27[5] 293-302).
But not all patch testing is the same: The study also found that 24% of the RPPT cases would have been missed if assessed with the T.R.U.E. TEST compared with extended patch testing. If a T.R.U.E. TEST fails to explain generalized atopic dermatitis, the patient should be sent for more comprehensive testing where available, Dr. Zippin advised.
Pediatric patients also have unique allergens clinicians should consider. In the same study, children had a number of allergens similar to those of adults as reported in previous studies, such as nickel, cobalt, and neomycin. However, propylene glycol and cocamidopropyl betaine were allergens identified as unique to the pediatric population.
Another study looking at the same group of patients found that compared with children who did not have AD, children with AD had 7.4 times higher odds of having an RPPT to cocamidopropyl betaine, 7.6 times higher odds of having an RPPT to parthenolide, 5.3 times higher odds of having an RPPT to tixocortol pivalate, 4.2 times higher odds of having an RPPT to wool alcohols, and 4 times higher odds of having an RPPT to lanolin (JAMA Dermatology 2017;153[8]:765-70).
All of these are components of topical medicaments used to treat AD, “either components of emollients that we recommend, or components of steroids that we recommend,” Dr. Zippin pointed out.
One of these allergens could be the culprit when a child develops a new rash but there are no new apparent changes in products, exposures, and activities. Lanolin, also called wool grease, is used in many skin care products, for example. Dr. Zippin described the case of a 6-year-old girl with a history of AD, who presented with a new rash on her scalp and behind her ears, not explained by any obvious changes to products, exposures, or activities. Subsequent patch testing determined that the rash was caused by baby shampoo, which contained cocamidopropyl betaine, which is used in hypoallergenic products. The rash resolved after a different shampoo was used.
“Sometimes, we really have to be thinking when the rash is getting worse, is there something they’re being exposed to that might be an allergen?” Dr. Zippin said.
In patients who have avoided all their positive allergens but a rash has not improved, clinicians should consider systemic contact dermatitis (SCD). Patients can develop SCD through different types of exposures, including transepidermal, transmucosal, oral, intravenous, subcutaneous, intramuscular, inhalation, and implantation routes.
SCD also has a variety of presentations, including pompholyx/dyshidrosis/vesicular dermatitis, maculopapular eruption, chronic pruritus, exfoliative erythroderma/toxiderma, chronic urticaria, erythema multiforme and vasculitis, hyperkeratotic papules of the elbows, acute generalized exanthematous pustulosis, and pruritus ani, according to Dr. Zippin.
SCD should be considered when a patient has a positive patch test to an allergen that is known to cause SCD, and does not clear after avoiding cutaneous exposure to the allergen, Dr. Zippin advised.
Patients will most often develop SCD from plants and herbs, Dr. Zippin noted. Chrysanthemums and chamomile tea are common culprits for compositae allergy and can trigger SCD; other causes are Anacardiaceae, Balsam of Peru, and propolis. Metals (nickel, cobalt, gold, and chromium), medications (aminoglycosides, corticosteroids, and ethylenediamine), and other sources (formaldehyde, propylene glycol in frozen foods, gallates, and methylisothiazolinone) can cause SCD as well.
Methylisothiazolinone in particular is a very common sensitizer, Dr. Zippin said. “If you have a patient who is positive to this, it’s almost always the cause of their problem.”
Balsam of Peru is in a number of different foods, and patients who need to follow a diet free of Balsam of Peru should avoid a long list of foods including citrus; bakery goods; Danish pastry; candy; gum; spices such as cinnamon, cloves, vanilla, curry, allspice, anise, and ginger; spicy condiments such as ketchup, chili sauce, barbecue sauce; chili, pizza, and foods with red sauces; tomatoes; pickles; alcohol (wine, beer, gin, vermouth); tea (perfumed or flavored); tobacco; chocolate and ice cream; and soft drinks (cola or spiced soft drinks).
Patients starting a nickel-free diet should avoid soy, peanuts and other nuts, legumes, chocolate, cocoa, oats, fish, and whole wheat flours. Any elimination diet should last for 3 months but should at least be tried for 3-4 weeks, with gradual reintroduction of foods suspected as triggers once per week. Any type I allergies that are discovered or suspected can be referred to an allergist for allergen challenge and desensitization therapy.
For more information, Dr. Zippin recommended the American Contact Dermatitis Society website for more information.
Dr. Zippin reported that he is the founder and holds stock options at CEP Biotech; is on the medical advisory board and receives stock options from YouV Labs., is a paid consultant and performs industry-sponsored research for Pfizer, receives stock options from Regeneron, and is on the medical advisory board for Hoth Therapeutics Inc. He is on the board of directors for the American Contact Dermatitis Society.
EXPERT ANALYSIS FROM ODAC 2020
Equal Access Makes A Difference in Surviving Prostate Cancer
In the general US population, African American men are more than twice as likely as non-Hispanic white men to die of prostate cancer. Researchers from the University of California at San Diego, though, speculated that disparities in access to care and not racial differences might be driving the differing outcomes. They turned to the US Department of Veterans Affairs (VA) with its “equal-access medical system” to find out.
Using data from a longitudinal database of > 20 million veterans, the researchers followed 18,201 black and 41,834 white patients with prostate cancer who were diagnosed between 2000 and 2015 and received care through the VA. The results of the study were published in Cancer.
African American men at diagnosis were younger (median age, 63 vs 66 years), more likely to smoke, and had more general health problems than did white men. Black patients also had higher prostate-specific antigen levels (median, 6.7 ng/mL vs 6.2 ng/mL) but were less likely to have Gleason score 8 to 10 disease, a clinical T classification ≥ 3, or distant metastatic disease.
There was no difference between the groups in time from diagnosis to treatment. The 10-year prostate cancer-specific mortality rate was actually slightly lower for African American men: 4.4%, compared with 5.1% for white men.
Thus, the researchers concluded that because African American men who receive VA healthcare do not appear to present with more advanced disease, or experience worse outcomes than do white men—in contrast to national trends. Therefore, they determined that access to care may be an important determinant of racial equity.
“Prior outcomes for African Americans with prostate cancer don’t have to be a foregone conclusion,” the senior author, Brent Rose, MD, told The New York Times. “They are at least partly due to policy decisions we make about access to care.”
In the general US population, African American men are more than twice as likely as non-Hispanic white men to die of prostate cancer. Researchers from the University of California at San Diego, though, speculated that disparities in access to care and not racial differences might be driving the differing outcomes. They turned to the US Department of Veterans Affairs (VA) with its “equal-access medical system” to find out.
Using data from a longitudinal database of > 20 million veterans, the researchers followed 18,201 black and 41,834 white patients with prostate cancer who were diagnosed between 2000 and 2015 and received care through the VA. The results of the study were published in Cancer.
African American men at diagnosis were younger (median age, 63 vs 66 years), more likely to smoke, and had more general health problems than did white men. Black patients also had higher prostate-specific antigen levels (median, 6.7 ng/mL vs 6.2 ng/mL) but were less likely to have Gleason score 8 to 10 disease, a clinical T classification ≥ 3, or distant metastatic disease.
There was no difference between the groups in time from diagnosis to treatment. The 10-year prostate cancer-specific mortality rate was actually slightly lower for African American men: 4.4%, compared with 5.1% for white men.
Thus, the researchers concluded that because African American men who receive VA healthcare do not appear to present with more advanced disease, or experience worse outcomes than do white men—in contrast to national trends. Therefore, they determined that access to care may be an important determinant of racial equity.
“Prior outcomes for African Americans with prostate cancer don’t have to be a foregone conclusion,” the senior author, Brent Rose, MD, told The New York Times. “They are at least partly due to policy decisions we make about access to care.”
In the general US population, African American men are more than twice as likely as non-Hispanic white men to die of prostate cancer. Researchers from the University of California at San Diego, though, speculated that disparities in access to care and not racial differences might be driving the differing outcomes. They turned to the US Department of Veterans Affairs (VA) with its “equal-access medical system” to find out.
Using data from a longitudinal database of > 20 million veterans, the researchers followed 18,201 black and 41,834 white patients with prostate cancer who were diagnosed between 2000 and 2015 and received care through the VA. The results of the study were published in Cancer.
African American men at diagnosis were younger (median age, 63 vs 66 years), more likely to smoke, and had more general health problems than did white men. Black patients also had higher prostate-specific antigen levels (median, 6.7 ng/mL vs 6.2 ng/mL) but were less likely to have Gleason score 8 to 10 disease, a clinical T classification ≥ 3, or distant metastatic disease.
There was no difference between the groups in time from diagnosis to treatment. The 10-year prostate cancer-specific mortality rate was actually slightly lower for African American men: 4.4%, compared with 5.1% for white men.
Thus, the researchers concluded that because African American men who receive VA healthcare do not appear to present with more advanced disease, or experience worse outcomes than do white men—in contrast to national trends. Therefore, they determined that access to care may be an important determinant of racial equity.
“Prior outcomes for African Americans with prostate cancer don’t have to be a foregone conclusion,” the senior author, Brent Rose, MD, told The New York Times. “They are at least partly due to policy decisions we make about access to care.”
FDA not recommending recalls of diabetes drug metformin
The Food and Drug Administration says it has no plans to recall any metformin products, used for the treatment of type 2 diabetes, after tests it conducted did not show any evidence of contamination with N-nitrosodimethylamine (NDMA) at levels that would cause concern.
The FDA began testing samples of metformin for the carcinogen NDMA at the end of 2019. Contamination with this substance has led to recalls of hypertension and heartburn medications within the past 2 years.
That announcement came on the heels of a recall of three versions of metformin in Singapore and the European Medicines Agency’s request that manufacturers test for NDMA.
This week, the FDA posted laboratory results in which NDMA levels in some metformin products ranged from “not detectable to low.”
“To date, no sample of metformin that FDA has tested exceeds the acceptable daily intake for NDMA. FDA has not recommended metformin recalls in the U.S.,” the agency indicates.
More than 30 million people in the United States have diabetes; 90%-95% of cases are of type 2. Metformin is the fourth most prescribed drug in the United States.
“Patients should continue taking metformin to keep their diabetes under control,” the FDA emphasized. “It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals.”
The agency plans to post the methods used in laboratory testing of metformin in the near future. The FDA is collaborating with international regulators to share testing results for metformin, along with testing results for other drugs.
The U.S. agency says it will continue to monitor NDMA in metformin, along with other drug products, and will provide timely updates of new developments, including product recalls.
For more information about NDMA, visit the FDA’s nitrosamines webpage.
The FDA also encourages health care professionals and patients to report adverse reactions or quality problems with any human drugs to the agency’s MedWatch Adverse Event Reporting program.
This article first appeared on Medscape.com.
The Food and Drug Administration says it has no plans to recall any metformin products, used for the treatment of type 2 diabetes, after tests it conducted did not show any evidence of contamination with N-nitrosodimethylamine (NDMA) at levels that would cause concern.
The FDA began testing samples of metformin for the carcinogen NDMA at the end of 2019. Contamination with this substance has led to recalls of hypertension and heartburn medications within the past 2 years.
That announcement came on the heels of a recall of three versions of metformin in Singapore and the European Medicines Agency’s request that manufacturers test for NDMA.
This week, the FDA posted laboratory results in which NDMA levels in some metformin products ranged from “not detectable to low.”
“To date, no sample of metformin that FDA has tested exceeds the acceptable daily intake for NDMA. FDA has not recommended metformin recalls in the U.S.,” the agency indicates.
More than 30 million people in the United States have diabetes; 90%-95% of cases are of type 2. Metformin is the fourth most prescribed drug in the United States.
“Patients should continue taking metformin to keep their diabetes under control,” the FDA emphasized. “It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals.”
The agency plans to post the methods used in laboratory testing of metformin in the near future. The FDA is collaborating with international regulators to share testing results for metformin, along with testing results for other drugs.
The U.S. agency says it will continue to monitor NDMA in metformin, along with other drug products, and will provide timely updates of new developments, including product recalls.
For more information about NDMA, visit the FDA’s nitrosamines webpage.
The FDA also encourages health care professionals and patients to report adverse reactions or quality problems with any human drugs to the agency’s MedWatch Adverse Event Reporting program.
This article first appeared on Medscape.com.
The Food and Drug Administration says it has no plans to recall any metformin products, used for the treatment of type 2 diabetes, after tests it conducted did not show any evidence of contamination with N-nitrosodimethylamine (NDMA) at levels that would cause concern.
The FDA began testing samples of metformin for the carcinogen NDMA at the end of 2019. Contamination with this substance has led to recalls of hypertension and heartburn medications within the past 2 years.
That announcement came on the heels of a recall of three versions of metformin in Singapore and the European Medicines Agency’s request that manufacturers test for NDMA.
This week, the FDA posted laboratory results in which NDMA levels in some metformin products ranged from “not detectable to low.”
“To date, no sample of metformin that FDA has tested exceeds the acceptable daily intake for NDMA. FDA has not recommended metformin recalls in the U.S.,” the agency indicates.
More than 30 million people in the United States have diabetes; 90%-95% of cases are of type 2. Metformin is the fourth most prescribed drug in the United States.
“Patients should continue taking metformin to keep their diabetes under control,” the FDA emphasized. “It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals.”
The agency plans to post the methods used in laboratory testing of metformin in the near future. The FDA is collaborating with international regulators to share testing results for metformin, along with testing results for other drugs.
The U.S. agency says it will continue to monitor NDMA in metformin, along with other drug products, and will provide timely updates of new developments, including product recalls.
For more information about NDMA, visit the FDA’s nitrosamines webpage.
The FDA also encourages health care professionals and patients to report adverse reactions or quality problems with any human drugs to the agency’s MedWatch Adverse Event Reporting program.
This article first appeared on Medscape.com.
Choice of infant sleep location is multifactorial
according to a recent nationally representative study.
Of 3,260 mothers surveyed, 59% of mothers said that they intended to room-share without bed-sharing, but only 45% practiced – and also had the intent to practice – room-sharing without bed-sharing. Of the 41% who said that they did not intend to bed-share, 24% actually did intend to practice at least some bed-sharing with their infants, who were all aged 2-6 months at the time of survey administration.
Mothers who were African American and those who were breastfeeding exclusively were most likely to report that they intended to bed-share, reported Ann Kellams, MD, of the department of pediatrics at the University of Virginia,Charlottesville, and coauthors. Mothers who were exclusively breastfeeding had a nearly threefold higher rate of intending to bed-share than mothers whose infants were fed formula.
How mothers perceived social norms about bed- and room-sharing practices also plays a role. Women who considered that social norms supported bed-sharing and discouraged room-sharing had almost 200 times the odds of intending to bed-share, compared with those who perceived that social norms supported room-sharing without bed-sharing.
Conversely, being advised by a doctor to follow the American Academy of Pediatrics–recommended practice of room-sharing without bed-sharing made it less likely that mothers would plan to share a bed with their infant (adjusted odds ratio, 0.56). Yet women who intended to room-share without bed-sharing but who actually did bed-share some of the time, their doctor’s advice to room-share only had no impact (aOR, 1.01).
The investigators noted that, “although other studies have investigated factors influencing maternal decisions, no studies to date have examined maternal intention regarding sleep location and what factors influence intention.”
The Study of Attitudes and Factors Effecting Infant Care drew from 32 U.S. hospitals, and asked mothers about feeding and care practices, including the infant’s usual sleep locations and all sleep locations over the 2 weeks preceding the survey. Additionally, the survey asked about future intent for sleeping practices, looking ahead to the next 2 weeks.
The survey design and the analysis performed in the study were based on the theory of planned behavior (TPB), “which hypothesizes that attitudes, subjective social norms, and perceptions about control over behavior impact one’s intention, which leads to actual behavior,” explained Dr. Kellams and coinvestigators. They reported that they had previously used TPB to analyze mothers’ intentions and actions regarding supine sleep position for infants, finding that a variety of behavioral and social facets accounted for by TPB affected maternal intention and decision making.
Additionally, the study’s design captured partial-night bed-sharing, where an infant may start the night in a separate bed but be brought to bed for feeding or comforting, then share a bed with the mother for the remainder of the night. “Unintended bed-sharing may explain our finding that there is frequent inconsistency between those whose near-future intention is to room-share without bed-sharing but whose actual practice includes bed-sharing,” the authors wrote.
“Attitudes, social norms, and doctor advice are associated with infant sleep location and may be potential targets for educational interventions,” concluded Dr. Kellams and coinvestigators.
Dr. Kellams and associates reported no relevant financial disclosures. The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health.
SOURCE: Kellams A et al. Pediatrics. 2020 Feb 7;145(3):e20191523.
according to a recent nationally representative study.
Of 3,260 mothers surveyed, 59% of mothers said that they intended to room-share without bed-sharing, but only 45% practiced – and also had the intent to practice – room-sharing without bed-sharing. Of the 41% who said that they did not intend to bed-share, 24% actually did intend to practice at least some bed-sharing with their infants, who were all aged 2-6 months at the time of survey administration.
Mothers who were African American and those who were breastfeeding exclusively were most likely to report that they intended to bed-share, reported Ann Kellams, MD, of the department of pediatrics at the University of Virginia,Charlottesville, and coauthors. Mothers who were exclusively breastfeeding had a nearly threefold higher rate of intending to bed-share than mothers whose infants were fed formula.
How mothers perceived social norms about bed- and room-sharing practices also plays a role. Women who considered that social norms supported bed-sharing and discouraged room-sharing had almost 200 times the odds of intending to bed-share, compared with those who perceived that social norms supported room-sharing without bed-sharing.
Conversely, being advised by a doctor to follow the American Academy of Pediatrics–recommended practice of room-sharing without bed-sharing made it less likely that mothers would plan to share a bed with their infant (adjusted odds ratio, 0.56). Yet women who intended to room-share without bed-sharing but who actually did bed-share some of the time, their doctor’s advice to room-share only had no impact (aOR, 1.01).
The investigators noted that, “although other studies have investigated factors influencing maternal decisions, no studies to date have examined maternal intention regarding sleep location and what factors influence intention.”
The Study of Attitudes and Factors Effecting Infant Care drew from 32 U.S. hospitals, and asked mothers about feeding and care practices, including the infant’s usual sleep locations and all sleep locations over the 2 weeks preceding the survey. Additionally, the survey asked about future intent for sleeping practices, looking ahead to the next 2 weeks.
The survey design and the analysis performed in the study were based on the theory of planned behavior (TPB), “which hypothesizes that attitudes, subjective social norms, and perceptions about control over behavior impact one’s intention, which leads to actual behavior,” explained Dr. Kellams and coinvestigators. They reported that they had previously used TPB to analyze mothers’ intentions and actions regarding supine sleep position for infants, finding that a variety of behavioral and social facets accounted for by TPB affected maternal intention and decision making.
Additionally, the study’s design captured partial-night bed-sharing, where an infant may start the night in a separate bed but be brought to bed for feeding or comforting, then share a bed with the mother for the remainder of the night. “Unintended bed-sharing may explain our finding that there is frequent inconsistency between those whose near-future intention is to room-share without bed-sharing but whose actual practice includes bed-sharing,” the authors wrote.
“Attitudes, social norms, and doctor advice are associated with infant sleep location and may be potential targets for educational interventions,” concluded Dr. Kellams and coinvestigators.
Dr. Kellams and associates reported no relevant financial disclosures. The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health.
SOURCE: Kellams A et al. Pediatrics. 2020 Feb 7;145(3):e20191523.
according to a recent nationally representative study.
Of 3,260 mothers surveyed, 59% of mothers said that they intended to room-share without bed-sharing, but only 45% practiced – and also had the intent to practice – room-sharing without bed-sharing. Of the 41% who said that they did not intend to bed-share, 24% actually did intend to practice at least some bed-sharing with their infants, who were all aged 2-6 months at the time of survey administration.
Mothers who were African American and those who were breastfeeding exclusively were most likely to report that they intended to bed-share, reported Ann Kellams, MD, of the department of pediatrics at the University of Virginia,Charlottesville, and coauthors. Mothers who were exclusively breastfeeding had a nearly threefold higher rate of intending to bed-share than mothers whose infants were fed formula.
How mothers perceived social norms about bed- and room-sharing practices also plays a role. Women who considered that social norms supported bed-sharing and discouraged room-sharing had almost 200 times the odds of intending to bed-share, compared with those who perceived that social norms supported room-sharing without bed-sharing.
Conversely, being advised by a doctor to follow the American Academy of Pediatrics–recommended practice of room-sharing without bed-sharing made it less likely that mothers would plan to share a bed with their infant (adjusted odds ratio, 0.56). Yet women who intended to room-share without bed-sharing but who actually did bed-share some of the time, their doctor’s advice to room-share only had no impact (aOR, 1.01).
The investigators noted that, “although other studies have investigated factors influencing maternal decisions, no studies to date have examined maternal intention regarding sleep location and what factors influence intention.”
The Study of Attitudes and Factors Effecting Infant Care drew from 32 U.S. hospitals, and asked mothers about feeding and care practices, including the infant’s usual sleep locations and all sleep locations over the 2 weeks preceding the survey. Additionally, the survey asked about future intent for sleeping practices, looking ahead to the next 2 weeks.
The survey design and the analysis performed in the study were based on the theory of planned behavior (TPB), “which hypothesizes that attitudes, subjective social norms, and perceptions about control over behavior impact one’s intention, which leads to actual behavior,” explained Dr. Kellams and coinvestigators. They reported that they had previously used TPB to analyze mothers’ intentions and actions regarding supine sleep position for infants, finding that a variety of behavioral and social facets accounted for by TPB affected maternal intention and decision making.
Additionally, the study’s design captured partial-night bed-sharing, where an infant may start the night in a separate bed but be brought to bed for feeding or comforting, then share a bed with the mother for the remainder of the night. “Unintended bed-sharing may explain our finding that there is frequent inconsistency between those whose near-future intention is to room-share without bed-sharing but whose actual practice includes bed-sharing,” the authors wrote.
“Attitudes, social norms, and doctor advice are associated with infant sleep location and may be potential targets for educational interventions,” concluded Dr. Kellams and coinvestigators.
Dr. Kellams and associates reported no relevant financial disclosures. The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health.
SOURCE: Kellams A et al. Pediatrics. 2020 Feb 7;145(3):e20191523.
FROM PEDIATRICS
Posttraumatic stress may persist up to 9 months after pregnancy loss
new research suggests.
The outcomes of a prospective cohort study involving 737 women who had experienced miscarriage or ectopic pregnancy and 171 controls with healthy pregnancies were presented in a report in the American Journal of Obstetrics & Gynecology.
One month after their pregnancy loss, 29% of these women met the criteria for posttraumatic stress, 24% reported moderate to severe anxiety, and 11% reported moderate to severe depression. In comparison, just 13% of women in the control group met the criteria for anxiety, and 2% met the criteria for depression, which meant women who had experienced early pregnancy loss had a greater than twofold odds of anxiety and nearly fourfold (odds ratio, 3.88) greater odds of depression, reported Jessica Farren, PhD, of the Queen Charlotte’s and Chelsea Hospital, London, and coauthors.
The most common posttraumatic symptom, experienced by 91% of respondents with posttraumatic stress at 1 month after the pregnancy, was reexperiencing symptoms, while 60% experienced avoidance and hyperarousal symptoms. At 3 months after the loss, 50% of those with posttraumatic stress reported an interruption of their general satisfaction with life.
While the incidence of posttraumatic stress, anxiety, and depression decreased over time in the women who had early pregnancy loss, by the third month 21% still met the criteria for posttraumatic stress, and by 9 months, 18% still were experiencing posttraumatic stress. Similarly, moderate to severe anxiety was still present in 23% of women at 3 months and 17% at 9 months, and moderate to severe depression was still experienced by 8% of women at 3 months and 6% of women at 9 months.
Dr. Farren and coauthors wrote that, given the incidence of miscarriage and ectopic pregnancy in the population, the high proportion of women still experiencing posttraumatic stress, anxiety, and depression at 9 months pointed to a significant public health issue. “It is recognized that PTSD in other contexts can have a significant impact on work, social interaction, health care utilization, and risks in future pregnancies,” they wrote. “Work is needed to evaluate strategies to effectively identify and treat affected women with these specific psychopathologies.”
The investigators also looked at the differences in outcomes in women who experienced miscarriage, compared with those who experienced ectopic pregnancy.
Of the 363 women who had a miscarriage, 30% met criteria for posttraumatic stress at 1 month, 20% at 3 months, and 17% at 9 months. Moderate to severe anxiety was reported by 25% women at 1 month, 22% at 3 months, and 17% at 9 months. Moderate to severe depression was reported by 12% at 1 month, 7% at 3 months, and 5% at 9 months.
Of the 74 women who had an ectopic pregnancy, 23% met criteria for posttraumatic stress at 1 month, 28% at 3 months, and 21% at 9 months. Moderate to severe anxiety was reported by 21% at 1 month, 30% at 3 months, and 23% at 9 months. Moderate to severe depression was reported by 7% at 1 month, 12% at 3 months, and 11% at 9 months.
The authors noted that the incidence of posttraumatic stress, anxiety, and depression decreased more strongly over time in women who had experienced miscarriage, compared with those who experienced ectopic pregnancy, although they commented that the confidence intervals were wide.
One coauthor was supported by an Imperial Health Charity grant and another by the National Institute for Health Research Biomedical Research Centre. No conflicts of interest were declared.
SOURCE: Farren J et al. Amer J Obstet Gynecol. 2019 Dec 13. doi: 10.1016/j.ajog.2019.10.102.
new research suggests.
The outcomes of a prospective cohort study involving 737 women who had experienced miscarriage or ectopic pregnancy and 171 controls with healthy pregnancies were presented in a report in the American Journal of Obstetrics & Gynecology.
One month after their pregnancy loss, 29% of these women met the criteria for posttraumatic stress, 24% reported moderate to severe anxiety, and 11% reported moderate to severe depression. In comparison, just 13% of women in the control group met the criteria for anxiety, and 2% met the criteria for depression, which meant women who had experienced early pregnancy loss had a greater than twofold odds of anxiety and nearly fourfold (odds ratio, 3.88) greater odds of depression, reported Jessica Farren, PhD, of the Queen Charlotte’s and Chelsea Hospital, London, and coauthors.
The most common posttraumatic symptom, experienced by 91% of respondents with posttraumatic stress at 1 month after the pregnancy, was reexperiencing symptoms, while 60% experienced avoidance and hyperarousal symptoms. At 3 months after the loss, 50% of those with posttraumatic stress reported an interruption of their general satisfaction with life.
While the incidence of posttraumatic stress, anxiety, and depression decreased over time in the women who had early pregnancy loss, by the third month 21% still met the criteria for posttraumatic stress, and by 9 months, 18% still were experiencing posttraumatic stress. Similarly, moderate to severe anxiety was still present in 23% of women at 3 months and 17% at 9 months, and moderate to severe depression was still experienced by 8% of women at 3 months and 6% of women at 9 months.
Dr. Farren and coauthors wrote that, given the incidence of miscarriage and ectopic pregnancy in the population, the high proportion of women still experiencing posttraumatic stress, anxiety, and depression at 9 months pointed to a significant public health issue. “It is recognized that PTSD in other contexts can have a significant impact on work, social interaction, health care utilization, and risks in future pregnancies,” they wrote. “Work is needed to evaluate strategies to effectively identify and treat affected women with these specific psychopathologies.”
The investigators also looked at the differences in outcomes in women who experienced miscarriage, compared with those who experienced ectopic pregnancy.
Of the 363 women who had a miscarriage, 30% met criteria for posttraumatic stress at 1 month, 20% at 3 months, and 17% at 9 months. Moderate to severe anxiety was reported by 25% women at 1 month, 22% at 3 months, and 17% at 9 months. Moderate to severe depression was reported by 12% at 1 month, 7% at 3 months, and 5% at 9 months.
Of the 74 women who had an ectopic pregnancy, 23% met criteria for posttraumatic stress at 1 month, 28% at 3 months, and 21% at 9 months. Moderate to severe anxiety was reported by 21% at 1 month, 30% at 3 months, and 23% at 9 months. Moderate to severe depression was reported by 7% at 1 month, 12% at 3 months, and 11% at 9 months.
The authors noted that the incidence of posttraumatic stress, anxiety, and depression decreased more strongly over time in women who had experienced miscarriage, compared with those who experienced ectopic pregnancy, although they commented that the confidence intervals were wide.
One coauthor was supported by an Imperial Health Charity grant and another by the National Institute for Health Research Biomedical Research Centre. No conflicts of interest were declared.
SOURCE: Farren J et al. Amer J Obstet Gynecol. 2019 Dec 13. doi: 10.1016/j.ajog.2019.10.102.
new research suggests.
The outcomes of a prospective cohort study involving 737 women who had experienced miscarriage or ectopic pregnancy and 171 controls with healthy pregnancies were presented in a report in the American Journal of Obstetrics & Gynecology.
One month after their pregnancy loss, 29% of these women met the criteria for posttraumatic stress, 24% reported moderate to severe anxiety, and 11% reported moderate to severe depression. In comparison, just 13% of women in the control group met the criteria for anxiety, and 2% met the criteria for depression, which meant women who had experienced early pregnancy loss had a greater than twofold odds of anxiety and nearly fourfold (odds ratio, 3.88) greater odds of depression, reported Jessica Farren, PhD, of the Queen Charlotte’s and Chelsea Hospital, London, and coauthors.
The most common posttraumatic symptom, experienced by 91% of respondents with posttraumatic stress at 1 month after the pregnancy, was reexperiencing symptoms, while 60% experienced avoidance and hyperarousal symptoms. At 3 months after the loss, 50% of those with posttraumatic stress reported an interruption of their general satisfaction with life.
While the incidence of posttraumatic stress, anxiety, and depression decreased over time in the women who had early pregnancy loss, by the third month 21% still met the criteria for posttraumatic stress, and by 9 months, 18% still were experiencing posttraumatic stress. Similarly, moderate to severe anxiety was still present in 23% of women at 3 months and 17% at 9 months, and moderate to severe depression was still experienced by 8% of women at 3 months and 6% of women at 9 months.
Dr. Farren and coauthors wrote that, given the incidence of miscarriage and ectopic pregnancy in the population, the high proportion of women still experiencing posttraumatic stress, anxiety, and depression at 9 months pointed to a significant public health issue. “It is recognized that PTSD in other contexts can have a significant impact on work, social interaction, health care utilization, and risks in future pregnancies,” they wrote. “Work is needed to evaluate strategies to effectively identify and treat affected women with these specific psychopathologies.”
The investigators also looked at the differences in outcomes in women who experienced miscarriage, compared with those who experienced ectopic pregnancy.
Of the 363 women who had a miscarriage, 30% met criteria for posttraumatic stress at 1 month, 20% at 3 months, and 17% at 9 months. Moderate to severe anxiety was reported by 25% women at 1 month, 22% at 3 months, and 17% at 9 months. Moderate to severe depression was reported by 12% at 1 month, 7% at 3 months, and 5% at 9 months.
Of the 74 women who had an ectopic pregnancy, 23% met criteria for posttraumatic stress at 1 month, 28% at 3 months, and 21% at 9 months. Moderate to severe anxiety was reported by 21% at 1 month, 30% at 3 months, and 23% at 9 months. Moderate to severe depression was reported by 7% at 1 month, 12% at 3 months, and 11% at 9 months.
The authors noted that the incidence of posttraumatic stress, anxiety, and depression decreased more strongly over time in women who had experienced miscarriage, compared with those who experienced ectopic pregnancy, although they commented that the confidence intervals were wide.
One coauthor was supported by an Imperial Health Charity grant and another by the National Institute for Health Research Biomedical Research Centre. No conflicts of interest were declared.
SOURCE: Farren J et al. Amer J Obstet Gynecol. 2019 Dec 13. doi: 10.1016/j.ajog.2019.10.102.
FROM THE AMERICAN JOURNAL OF OBSTETRICS & GYNECOLOGY
Mailed fecal testing may catch more cancer than endoscopic screening
On a population level, mailed fecal immunohistochemical tests (FITs) may catch more cases of advanced neoplasia than endoscopic methods, based on a Dutch screening study that invited more than 30,000 people to participate.
, reported lead author Esmée J. Grobbee, MD, of Erasmus University Medical Centre in Rotterdam, the Netherlands, and colleagues.
In addition to high participation, previous research has shown that successful FIT screening depends upon continued adherence to the screening program, the investigators wrote in Clinical Gastroenterology and Hepatology. They noted that, in the present study, just two rounds of FIT were needed to outperform endoscopic methods, and that these comparative findings are a first for the field.
“No literature is available on the comparison between endoscopic screening strategies and multiple rounds of FIT screening,” the investigators wrote. “It is of key importance for policy makers to know the impact of different screening programs over multiple rounds with long-term follow-up.”
To this end, the investigators invited 30,052 screening-naive people in the Netherlands to participate in the present study. Each invitation was for one of three groups: once-only colonoscopy, once-only flexible sigmoidoscopy, or four rounds of FIT. All individuals received an advanced notification by mail followed 2 weeks later by a more substantial information kit (and first FIT test when applicable). If these steps received no response, a reminder was sent 6 weeks later.
Participants in the FIT group received one test every 2 years. Patients who had a positive FIT (hemoglobin concentration of at least 10 mcg Hb/g feces) were scheduled for a colonoscopy. Similarly, colonoscopies were performed in patients who had concerning findings on flexible sigmoidoscopy (e.g., sessile serrated adenoma. This sequential system reduced the relative number of colonoscopies in these two groups; colonoscopy rates in the FIT group and flexible sigmoidoscopy group were 13% and 3%, respectively, compared with the 24% participation rate in the colonoscopy group.
At a population level, FIT screening had the highest advanced neoplasia detection rate, at 4.5%, compared with 2.3% and 2.2% for screening by sigmoidoscopy and colonoscopy, respectively.
“In the intention-to-screen analysis, FIT already detected significantly more advanced neoplasia and colorectal cancer (CRC) after only 2 rounds of FIT, and this difference increased over rounds,” the investigators noted.
Again in the intention-to-screen population, mailed FIT detected three times as many cases of CRC than either of the other two groups (0.6% vs. 0.2% for both). In contrast, colonoscopy and sigmoidoscopy had higher detection rates for nonadvanced adenomas, at 5.6% and 3.7%, respectively, compared with 3.2% for FIT, although the investigators noted that nonadvanced adenomas are “of uncertain clinical importance.” Sessile adenoma detection rates were similar across all three groups.
The as-screened analysis revealed higher detection rates of advanced neoplasia for colonoscopy (9.1%), compared with sigmoidoscopy (7.4%) and FIT (6.1%). In the same analysis, detection rates of colorectal cancer (CRC) were comparable across all three groups.
According to the investigators, the CRC-related findings require careful interpretation.
“Comparing CRC detection rates of FIT and endoscopic screening is complex … because CRCs detected in FIT screening could in theory have been prevented in a once-only colonoscopy by the removal of adenomas,” they wrote.
Still, the key takeaway of the study – that FIT screening was the most effective strategy – may have practical implications on a global scale, according to the investigators.
“Because many countries are considering implementing screening programs, the findings of this study aid in deciding on choice of screening strategies worldwide, which is based on expected participation rates and available colonoscopy resources,” they wrote.
The study was funded by the Netherlands Organization for Health Research and Development. The investigators disclosed no conflicts of interest.
SOURCE: Grobbee EJ et al. Clin Gastro Hepatol. 2019 Aug 13. doi: 10.1016/j.cgh.2019.08.015.
On a population level, mailed fecal immunohistochemical tests (FITs) may catch more cases of advanced neoplasia than endoscopic methods, based on a Dutch screening study that invited more than 30,000 people to participate.
, reported lead author Esmée J. Grobbee, MD, of Erasmus University Medical Centre in Rotterdam, the Netherlands, and colleagues.
In addition to high participation, previous research has shown that successful FIT screening depends upon continued adherence to the screening program, the investigators wrote in Clinical Gastroenterology and Hepatology. They noted that, in the present study, just two rounds of FIT were needed to outperform endoscopic methods, and that these comparative findings are a first for the field.
“No literature is available on the comparison between endoscopic screening strategies and multiple rounds of FIT screening,” the investigators wrote. “It is of key importance for policy makers to know the impact of different screening programs over multiple rounds with long-term follow-up.”
To this end, the investigators invited 30,052 screening-naive people in the Netherlands to participate in the present study. Each invitation was for one of three groups: once-only colonoscopy, once-only flexible sigmoidoscopy, or four rounds of FIT. All individuals received an advanced notification by mail followed 2 weeks later by a more substantial information kit (and first FIT test when applicable). If these steps received no response, a reminder was sent 6 weeks later.
Participants in the FIT group received one test every 2 years. Patients who had a positive FIT (hemoglobin concentration of at least 10 mcg Hb/g feces) were scheduled for a colonoscopy. Similarly, colonoscopies were performed in patients who had concerning findings on flexible sigmoidoscopy (e.g., sessile serrated adenoma. This sequential system reduced the relative number of colonoscopies in these two groups; colonoscopy rates in the FIT group and flexible sigmoidoscopy group were 13% and 3%, respectively, compared with the 24% participation rate in the colonoscopy group.
At a population level, FIT screening had the highest advanced neoplasia detection rate, at 4.5%, compared with 2.3% and 2.2% for screening by sigmoidoscopy and colonoscopy, respectively.
“In the intention-to-screen analysis, FIT already detected significantly more advanced neoplasia and colorectal cancer (CRC) after only 2 rounds of FIT, and this difference increased over rounds,” the investigators noted.
Again in the intention-to-screen population, mailed FIT detected three times as many cases of CRC than either of the other two groups (0.6% vs. 0.2% for both). In contrast, colonoscopy and sigmoidoscopy had higher detection rates for nonadvanced adenomas, at 5.6% and 3.7%, respectively, compared with 3.2% for FIT, although the investigators noted that nonadvanced adenomas are “of uncertain clinical importance.” Sessile adenoma detection rates were similar across all three groups.
The as-screened analysis revealed higher detection rates of advanced neoplasia for colonoscopy (9.1%), compared with sigmoidoscopy (7.4%) and FIT (6.1%). In the same analysis, detection rates of colorectal cancer (CRC) were comparable across all three groups.
According to the investigators, the CRC-related findings require careful interpretation.
“Comparing CRC detection rates of FIT and endoscopic screening is complex … because CRCs detected in FIT screening could in theory have been prevented in a once-only colonoscopy by the removal of adenomas,” they wrote.
Still, the key takeaway of the study – that FIT screening was the most effective strategy – may have practical implications on a global scale, according to the investigators.
“Because many countries are considering implementing screening programs, the findings of this study aid in deciding on choice of screening strategies worldwide, which is based on expected participation rates and available colonoscopy resources,” they wrote.
The study was funded by the Netherlands Organization for Health Research and Development. The investigators disclosed no conflicts of interest.
SOURCE: Grobbee EJ et al. Clin Gastro Hepatol. 2019 Aug 13. doi: 10.1016/j.cgh.2019.08.015.
On a population level, mailed fecal immunohistochemical tests (FITs) may catch more cases of advanced neoplasia than endoscopic methods, based on a Dutch screening study that invited more than 30,000 people to participate.
, reported lead author Esmée J. Grobbee, MD, of Erasmus University Medical Centre in Rotterdam, the Netherlands, and colleagues.
In addition to high participation, previous research has shown that successful FIT screening depends upon continued adherence to the screening program, the investigators wrote in Clinical Gastroenterology and Hepatology. They noted that, in the present study, just two rounds of FIT were needed to outperform endoscopic methods, and that these comparative findings are a first for the field.
“No literature is available on the comparison between endoscopic screening strategies and multiple rounds of FIT screening,” the investigators wrote. “It is of key importance for policy makers to know the impact of different screening programs over multiple rounds with long-term follow-up.”
To this end, the investigators invited 30,052 screening-naive people in the Netherlands to participate in the present study. Each invitation was for one of three groups: once-only colonoscopy, once-only flexible sigmoidoscopy, or four rounds of FIT. All individuals received an advanced notification by mail followed 2 weeks later by a more substantial information kit (and first FIT test when applicable). If these steps received no response, a reminder was sent 6 weeks later.
Participants in the FIT group received one test every 2 years. Patients who had a positive FIT (hemoglobin concentration of at least 10 mcg Hb/g feces) were scheduled for a colonoscopy. Similarly, colonoscopies were performed in patients who had concerning findings on flexible sigmoidoscopy (e.g., sessile serrated adenoma. This sequential system reduced the relative number of colonoscopies in these two groups; colonoscopy rates in the FIT group and flexible sigmoidoscopy group were 13% and 3%, respectively, compared with the 24% participation rate in the colonoscopy group.
At a population level, FIT screening had the highest advanced neoplasia detection rate, at 4.5%, compared with 2.3% and 2.2% for screening by sigmoidoscopy and colonoscopy, respectively.
“In the intention-to-screen analysis, FIT already detected significantly more advanced neoplasia and colorectal cancer (CRC) after only 2 rounds of FIT, and this difference increased over rounds,” the investigators noted.
Again in the intention-to-screen population, mailed FIT detected three times as many cases of CRC than either of the other two groups (0.6% vs. 0.2% for both). In contrast, colonoscopy and sigmoidoscopy had higher detection rates for nonadvanced adenomas, at 5.6% and 3.7%, respectively, compared with 3.2% for FIT, although the investigators noted that nonadvanced adenomas are “of uncertain clinical importance.” Sessile adenoma detection rates were similar across all three groups.
The as-screened analysis revealed higher detection rates of advanced neoplasia for colonoscopy (9.1%), compared with sigmoidoscopy (7.4%) and FIT (6.1%). In the same analysis, detection rates of colorectal cancer (CRC) were comparable across all three groups.
According to the investigators, the CRC-related findings require careful interpretation.
“Comparing CRC detection rates of FIT and endoscopic screening is complex … because CRCs detected in FIT screening could in theory have been prevented in a once-only colonoscopy by the removal of adenomas,” they wrote.
Still, the key takeaway of the study – that FIT screening was the most effective strategy – may have practical implications on a global scale, according to the investigators.
“Because many countries are considering implementing screening programs, the findings of this study aid in deciding on choice of screening strategies worldwide, which is based on expected participation rates and available colonoscopy resources,” they wrote.
The study was funded by the Netherlands Organization for Health Research and Development. The investigators disclosed no conflicts of interest.
SOURCE: Grobbee EJ et al. Clin Gastro Hepatol. 2019 Aug 13. doi: 10.1016/j.cgh.2019.08.015.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
GALAD score predicts NASH-HCC more than a year in advance
For patients with nonalcoholic steatohepatitis (NASH), the GALAD score may accurately predict hepatocellular carcinoma (HCC) as early as 560 days before diagnosis, according to investigators.
The GALAD score, which combines sex, age, alpha-fetoprotein-L3 (AFP-L3), alpha-fetoprotein, and des-gamma-carboxyprothrombin (DCP), could improve cancer surveillance among NASH patients whose obesity limits sensitivity of ultrasound, reported lead author Jan Best, MD, of the University Hospital Magdeburg in Germany, and colleagues.
“The limitations of ultrasound surveillance alone for early detection of HCC are particularly evident in patients with NASH,” the investigators wrote in Clinical Gastroenterology and Hepatology. “Serum-based biomarkers might be more effective, with or without ultrasound surveillance, for HCC surveillance in NASH patients, although data in this patient population are currently lacking. The current study assessed the performance of the GALAD score for early HCC detection in patients with NASH-related liver disease.”
The study consisted of two parts: first, a retrospective case-control analysis, and second, a phase 3 prospective trial that implemented the GALAD score in a real-world population.
The retrospective component of the study involved 126 NASH patients with HCC (cases) and 231 NASH patients without HCC (controls), all of whom were treated at eight centers in Germany. The median GALAD score was significantly higher among NASH patients with HCC than in those without (2.93 vs. –3.96; P less than .001). At an optimal cutoff of –1.334, the GALAD score predicted HCC with a sensitivity of 91.2% and a specificity of 95.2%. Each component of the GALAD score aligned with previously published findings, as patients with HCC were predominantly older men with elevated serum AFP-L3, AFP, and DCP. But a closer look at the data showed that the GALAD score more accurately predicted HCC than any of its constituent serum measurements in isolation. For any stage of HCC, GALAD had an area under the curve (AUC) of 0.96, compared with significantly lower values for AFP (0.88), AFP-L3 (0.86), and DCP (0.87). Similarly, for early-stage HCC, GALAD score AUC was 0.92, compared with significantly lower values for AFP (0.77), AFP-L3 (0.74), and DCP (0.87).
The accuracy of the GALAD score – for detection of both any-stage and early-stage HCC — remained high regardless of cirrhosis status. Among patients with cirrhosis, the AUC for any-stage HCC was 0.93, and 0.85 for early-stage HCC. For patients without cirrhosis, GALAD was slightly more predictive, based on AUC’s of 0.98 and 0.94 for detection of any-stage and early-stage HCC, respectively. Again, these accuracy values significantly outmatched each serum measurement in isolation.
“These data on NASH-HCC patients demonstrate that GALAD can detect HCC independent of cirrhosis or stage of HCC,” the investigators wrote. “Indeed, even early noncirrhotic NASH-HCC seems clearly separable from NASH controls, as even small groups resulted in robust performance.”
The prospective component of the study involved screening 392 patients with NASH at a single treatment center in Japan. From this cohort, 28 patients developed HCC after a median of 10.1 years. Many patients in this group had significantly higher GALAD scores for 5 or more years before being diagnosed with HCC, and scores rose sharply in the months preceding diagnosis. Depending on selected cutoff value, the GALAD score predicted HCC from 200 to 560 days prior to diagnosis.
“While this specific result has to be confirmed in further prospective studies, it is a promising observation for potential use of GALAD as a screening tool in NASH patients,” the investigators wrote.
“In conclusion, our data confirm that the GALAD score is superior to individual serum markers for detection of HCC in NASH, independent of tumor stage or cirrhosis,” the investigators wrote. “The findings suggest that GALAD should be investigated as a potential tool for screening of NASH individuals to detect HCC at a resectable stage in a sufficiently large prospective study to identify a cutoff.”
The study was funded by Deutsche Forschungsgemeinschaft, the Wilhelm-Laupitz Foundation, and the Werner Jackstaedt Foundation. The investigators declared no conflicts of interest.
SOURCE: Best J et al. Clin Gastro Hepatol. 2019 Nov 8. doi: 10.1016/j.cgh.2019.11.012.
There has been increasing recognition that ultrasound-based HCC surveillance in patients with cirrhosis has suboptimal sensitivity and specificity for early HCC detection, particularly when applied to those with nonalcoholic steatohepatitis (NASH). These data highlight the critical need for novel biomarkers to improve early HCC detection and reduce mortality. The study by Dr. Best and colleagues evaluated a blood-based biomarker panel, GALAD, in patients with NASH and found that it was able to detect HCC at an early stage with a sensitivity of 68% and specificity of 95% - performance comparable, if not superior, to that of abdominal ultrasound. In an accompanying pilot prospective cohort study, the authors also found GALAD may detect HCC more than 1 year prior to diagnosis. Although earlier studies had similarly demonstrated high performance of GALAD for early HCC detection, this study specifically examined patients with NASH - a cohort that increasingly accounts for HCC cases in the Western world but has been underrepresented in prior studies. Therefore, it is reassuring to know that GALAD appears to have high sensitivity and specificity in this patient group. However, while the data by Best et al. are promising, validation of these results in larger cohort studies is needed before routine adoption in clinical practice. Fortunately, maturation of phase 3 biomarker cohorts, including the Early Detection Research Network Hepatocellular Early Detection Strategy (EDRN HEDS) and Texas HCC Consortium, will facilitate this evaluation in the near future and will hopefully translate promising biomarkers into clinical practice.
Amit G. Singal, MD, is an associate professor of medicine, medical director of the liver tumor program, and chief of hepatology at UT Southwestern Medical Center, Dallas. He has served as a consultant for Wako Diagnostics, Glycotest, Exact Sciences, Roche Diagnostics, and TARGET Pharmasolutions.
There has been increasing recognition that ultrasound-based HCC surveillance in patients with cirrhosis has suboptimal sensitivity and specificity for early HCC detection, particularly when applied to those with nonalcoholic steatohepatitis (NASH). These data highlight the critical need for novel biomarkers to improve early HCC detection and reduce mortality. The study by Dr. Best and colleagues evaluated a blood-based biomarker panel, GALAD, in patients with NASH and found that it was able to detect HCC at an early stage with a sensitivity of 68% and specificity of 95% - performance comparable, if not superior, to that of abdominal ultrasound. In an accompanying pilot prospective cohort study, the authors also found GALAD may detect HCC more than 1 year prior to diagnosis. Although earlier studies had similarly demonstrated high performance of GALAD for early HCC detection, this study specifically examined patients with NASH - a cohort that increasingly accounts for HCC cases in the Western world but has been underrepresented in prior studies. Therefore, it is reassuring to know that GALAD appears to have high sensitivity and specificity in this patient group. However, while the data by Best et al. are promising, validation of these results in larger cohort studies is needed before routine adoption in clinical practice. Fortunately, maturation of phase 3 biomarker cohorts, including the Early Detection Research Network Hepatocellular Early Detection Strategy (EDRN HEDS) and Texas HCC Consortium, will facilitate this evaluation in the near future and will hopefully translate promising biomarkers into clinical practice.
Amit G. Singal, MD, is an associate professor of medicine, medical director of the liver tumor program, and chief of hepatology at UT Southwestern Medical Center, Dallas. He has served as a consultant for Wako Diagnostics, Glycotest, Exact Sciences, Roche Diagnostics, and TARGET Pharmasolutions.
There has been increasing recognition that ultrasound-based HCC surveillance in patients with cirrhosis has suboptimal sensitivity and specificity for early HCC detection, particularly when applied to those with nonalcoholic steatohepatitis (NASH). These data highlight the critical need for novel biomarkers to improve early HCC detection and reduce mortality. The study by Dr. Best and colleagues evaluated a blood-based biomarker panel, GALAD, in patients with NASH and found that it was able to detect HCC at an early stage with a sensitivity of 68% and specificity of 95% - performance comparable, if not superior, to that of abdominal ultrasound. In an accompanying pilot prospective cohort study, the authors also found GALAD may detect HCC more than 1 year prior to diagnosis. Although earlier studies had similarly demonstrated high performance of GALAD for early HCC detection, this study specifically examined patients with NASH - a cohort that increasingly accounts for HCC cases in the Western world but has been underrepresented in prior studies. Therefore, it is reassuring to know that GALAD appears to have high sensitivity and specificity in this patient group. However, while the data by Best et al. are promising, validation of these results in larger cohort studies is needed before routine adoption in clinical practice. Fortunately, maturation of phase 3 biomarker cohorts, including the Early Detection Research Network Hepatocellular Early Detection Strategy (EDRN HEDS) and Texas HCC Consortium, will facilitate this evaluation in the near future and will hopefully translate promising biomarkers into clinical practice.
Amit G. Singal, MD, is an associate professor of medicine, medical director of the liver tumor program, and chief of hepatology at UT Southwestern Medical Center, Dallas. He has served as a consultant for Wako Diagnostics, Glycotest, Exact Sciences, Roche Diagnostics, and TARGET Pharmasolutions.
For patients with nonalcoholic steatohepatitis (NASH), the GALAD score may accurately predict hepatocellular carcinoma (HCC) as early as 560 days before diagnosis, according to investigators.
The GALAD score, which combines sex, age, alpha-fetoprotein-L3 (AFP-L3), alpha-fetoprotein, and des-gamma-carboxyprothrombin (DCP), could improve cancer surveillance among NASH patients whose obesity limits sensitivity of ultrasound, reported lead author Jan Best, MD, of the University Hospital Magdeburg in Germany, and colleagues.
“The limitations of ultrasound surveillance alone for early detection of HCC are particularly evident in patients with NASH,” the investigators wrote in Clinical Gastroenterology and Hepatology. “Serum-based biomarkers might be more effective, with or without ultrasound surveillance, for HCC surveillance in NASH patients, although data in this patient population are currently lacking. The current study assessed the performance of the GALAD score for early HCC detection in patients with NASH-related liver disease.”
The study consisted of two parts: first, a retrospective case-control analysis, and second, a phase 3 prospective trial that implemented the GALAD score in a real-world population.
The retrospective component of the study involved 126 NASH patients with HCC (cases) and 231 NASH patients without HCC (controls), all of whom were treated at eight centers in Germany. The median GALAD score was significantly higher among NASH patients with HCC than in those without (2.93 vs. –3.96; P less than .001). At an optimal cutoff of –1.334, the GALAD score predicted HCC with a sensitivity of 91.2% and a specificity of 95.2%. Each component of the GALAD score aligned with previously published findings, as patients with HCC were predominantly older men with elevated serum AFP-L3, AFP, and DCP. But a closer look at the data showed that the GALAD score more accurately predicted HCC than any of its constituent serum measurements in isolation. For any stage of HCC, GALAD had an area under the curve (AUC) of 0.96, compared with significantly lower values for AFP (0.88), AFP-L3 (0.86), and DCP (0.87). Similarly, for early-stage HCC, GALAD score AUC was 0.92, compared with significantly lower values for AFP (0.77), AFP-L3 (0.74), and DCP (0.87).
The accuracy of the GALAD score – for detection of both any-stage and early-stage HCC — remained high regardless of cirrhosis status. Among patients with cirrhosis, the AUC for any-stage HCC was 0.93, and 0.85 for early-stage HCC. For patients without cirrhosis, GALAD was slightly more predictive, based on AUC’s of 0.98 and 0.94 for detection of any-stage and early-stage HCC, respectively. Again, these accuracy values significantly outmatched each serum measurement in isolation.
“These data on NASH-HCC patients demonstrate that GALAD can detect HCC independent of cirrhosis or stage of HCC,” the investigators wrote. “Indeed, even early noncirrhotic NASH-HCC seems clearly separable from NASH controls, as even small groups resulted in robust performance.”
The prospective component of the study involved screening 392 patients with NASH at a single treatment center in Japan. From this cohort, 28 patients developed HCC after a median of 10.1 years. Many patients in this group had significantly higher GALAD scores for 5 or more years before being diagnosed with HCC, and scores rose sharply in the months preceding diagnosis. Depending on selected cutoff value, the GALAD score predicted HCC from 200 to 560 days prior to diagnosis.
“While this specific result has to be confirmed in further prospective studies, it is a promising observation for potential use of GALAD as a screening tool in NASH patients,” the investigators wrote.
“In conclusion, our data confirm that the GALAD score is superior to individual serum markers for detection of HCC in NASH, independent of tumor stage or cirrhosis,” the investigators wrote. “The findings suggest that GALAD should be investigated as a potential tool for screening of NASH individuals to detect HCC at a resectable stage in a sufficiently large prospective study to identify a cutoff.”
The study was funded by Deutsche Forschungsgemeinschaft, the Wilhelm-Laupitz Foundation, and the Werner Jackstaedt Foundation. The investigators declared no conflicts of interest.
SOURCE: Best J et al. Clin Gastro Hepatol. 2019 Nov 8. doi: 10.1016/j.cgh.2019.11.012.
For patients with nonalcoholic steatohepatitis (NASH), the GALAD score may accurately predict hepatocellular carcinoma (HCC) as early as 560 days before diagnosis, according to investigators.
The GALAD score, which combines sex, age, alpha-fetoprotein-L3 (AFP-L3), alpha-fetoprotein, and des-gamma-carboxyprothrombin (DCP), could improve cancer surveillance among NASH patients whose obesity limits sensitivity of ultrasound, reported lead author Jan Best, MD, of the University Hospital Magdeburg in Germany, and colleagues.
“The limitations of ultrasound surveillance alone for early detection of HCC are particularly evident in patients with NASH,” the investigators wrote in Clinical Gastroenterology and Hepatology. “Serum-based biomarkers might be more effective, with or without ultrasound surveillance, for HCC surveillance in NASH patients, although data in this patient population are currently lacking. The current study assessed the performance of the GALAD score for early HCC detection in patients with NASH-related liver disease.”
The study consisted of two parts: first, a retrospective case-control analysis, and second, a phase 3 prospective trial that implemented the GALAD score in a real-world population.
The retrospective component of the study involved 126 NASH patients with HCC (cases) and 231 NASH patients without HCC (controls), all of whom were treated at eight centers in Germany. The median GALAD score was significantly higher among NASH patients with HCC than in those without (2.93 vs. –3.96; P less than .001). At an optimal cutoff of –1.334, the GALAD score predicted HCC with a sensitivity of 91.2% and a specificity of 95.2%. Each component of the GALAD score aligned with previously published findings, as patients with HCC were predominantly older men with elevated serum AFP-L3, AFP, and DCP. But a closer look at the data showed that the GALAD score more accurately predicted HCC than any of its constituent serum measurements in isolation. For any stage of HCC, GALAD had an area under the curve (AUC) of 0.96, compared with significantly lower values for AFP (0.88), AFP-L3 (0.86), and DCP (0.87). Similarly, for early-stage HCC, GALAD score AUC was 0.92, compared with significantly lower values for AFP (0.77), AFP-L3 (0.74), and DCP (0.87).
The accuracy of the GALAD score – for detection of both any-stage and early-stage HCC — remained high regardless of cirrhosis status. Among patients with cirrhosis, the AUC for any-stage HCC was 0.93, and 0.85 for early-stage HCC. For patients without cirrhosis, GALAD was slightly more predictive, based on AUC’s of 0.98 and 0.94 for detection of any-stage and early-stage HCC, respectively. Again, these accuracy values significantly outmatched each serum measurement in isolation.
“These data on NASH-HCC patients demonstrate that GALAD can detect HCC independent of cirrhosis or stage of HCC,” the investigators wrote. “Indeed, even early noncirrhotic NASH-HCC seems clearly separable from NASH controls, as even small groups resulted in robust performance.”
The prospective component of the study involved screening 392 patients with NASH at a single treatment center in Japan. From this cohort, 28 patients developed HCC after a median of 10.1 years. Many patients in this group had significantly higher GALAD scores for 5 or more years before being diagnosed with HCC, and scores rose sharply in the months preceding diagnosis. Depending on selected cutoff value, the GALAD score predicted HCC from 200 to 560 days prior to diagnosis.
“While this specific result has to be confirmed in further prospective studies, it is a promising observation for potential use of GALAD as a screening tool in NASH patients,” the investigators wrote.
“In conclusion, our data confirm that the GALAD score is superior to individual serum markers for detection of HCC in NASH, independent of tumor stage or cirrhosis,” the investigators wrote. “The findings suggest that GALAD should be investigated as a potential tool for screening of NASH individuals to detect HCC at a resectable stage in a sufficiently large prospective study to identify a cutoff.”
The study was funded by Deutsche Forschungsgemeinschaft, the Wilhelm-Laupitz Foundation, and the Werner Jackstaedt Foundation. The investigators declared no conflicts of interest.
SOURCE: Best J et al. Clin Gastro Hepatol. 2019 Nov 8. doi: 10.1016/j.cgh.2019.11.012.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY