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Guidance for the Clinical Management of Thirdhand Smoke Exposure in the Child Health Care Setting
From the Center for Child and Adolescent Health Research and Policy, Division of General Academic Pediatrics, Massachusetts General Hospital for Children, and the Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, MA.
Abstract
- Objective: To explain the concept of thirdhand smoke and how it can be used to protect the health of children and improve delivery of tobacco control interventions for parents in the child health care setting.
- Methods: Review of the literature and descriptive report.
- Results: The thirdhand smoke concept has been used in the CEASE intervention to improve the delivery of tobacco control counseling and services to parents. Materials and techniques have been developed for the child health care setting that use the concept of thirdhand smoke. Scientific findings demonstrate that thirdhand smoke exposure is harmful and establishes the need for clinicians to communicate the cessation imperative: the only way to protect non-smoking household members from thirdhand smoke is for all household smokers to quit smoking completely. As the scientific knowledge of thirdhand smoke increases, advocates will likely rely on it to encourage completely smoke-free places.
- Conclusion: Recent scientific studies on thirdhand smoke are impelling further research on the topic, spurring the creation of tobacco control policies to protect people from thridhand smoke and stimulating improvements to the delivery of tobacco control counseling and services to parents in child health care settings.
Key words: thirdhand smoke; smoking; tobacco; indoor air quality; smoking cessation; pediatrics.
While “thirdhand smoke” may be a relatively new term, it is rooted in an old concept—the particulate matter and residue from tobacco smoke left behind after tobacco is burned. In 1953, Dr. Ernest Wynder and his colleagues from the Washington University School of Medicine in St. Louis showed that condensate made from the residue of cigarette smoke causes cancer [1]. This residue left behind by burning cigarettes is now known as thirdhand smoke [2]. Dr. Wynder used acetone to rinse the leftover tobacco smoke residue from a smoking chamber where he had burned cigarettes. He then painted the solution of acetone and thirdhand smoke residue onto the backs of mice. The results of Dr. Wynder’s study demonstrated that exposed mice developed cancerous skin lesions, whereas mice exposed to the acetone alone did not display skin lesions. Dr. Wynder sounded an alarm bell in his manuscript when he wrote, “Such studies, in view of the corollary clinical data relating smoking to various types of cancer, appear urgent. They may result not only in furthering our knowledge of carcinogenesis, but in promoting some practical aspects of cancer prevention [1].”
Decades of research has been conducted since Dr. Wynder’s discovery to definitively conclude that smoking tobacco and exposure to secondhand tobacco smoke is harmful to human health. It is estimated that 480,000 annual premature deaths in the United States alone are attributable to smoking and exposure to secondhand smoke [3]. The World Health Organization estimates that worldwide tobacco use is responsible for more than 7 million deaths per year, with 890,000 of those deaths caused by secondhand smoke exposure of nonsmokers [4]. Epidemiological evidence of the harm posed by tobacco has spurred the U.S Surgeon General to conclude that there is no risk-free level of exposure to tobacco smoke [5]. Despite the overwhelming evidence implicating tobacco as the cause of an unprecedented amount of disease resulting from the use of a consumer product, only recently has a dedicated research agenda been pursued to study what Dr. Wynder urgently called for back in 1953: further exploration of the health effects of thirdhand tobacco smoke.
The term "thirdhand smoke" was first coined in 2006 by researchers with the Clinical Effort Against Secondhand Smoke Exposure (CEASE) program at Massachusetts General Hospital in Boston [6], and recent research has begun to shed considerable light on the topic. In 2011, a research consortium of scientists funded by the Tobacco-Related Disease Research Program [7] in California was set up to conduct pioneering research on the characterization, exposure and health effects of thirdhand tobacco smoke [8]. Research findings from this consortium and other scientists from around the world are quickly expanding and disseminating knowledge on this important topic.
While the research on thirdhand smoke is ongoing, this paper summarizes the current literature most relevant to the pediatric population and outlines clinical and policy recommendations to protect children and families from the harms of exposure to thirdhand smoke.
What Is Thirdhand Smoke and How Is It Different from Secondhand Smoke?
Thirdhand smoke is a result of combusted tobacco, most often from smoking cigarettes, pipes, cigars, or cigarillos. Thirdhand smoke remains on surfaces and in dust for a longtime after smoking happens, reacts with oxidants and other compounds to form secondary pollutants, and is re-emitted as a gas and/or resuspended when particles are disturbed and go back into the air where they can be inhaled [9]. One dramatic example of how thirdhand smoke can remain on surfaces long after secondhand smoke dissipates was discovered on the ornate constellation ceiling in the main concourse of the Grand Central Terminal in New York City. According to Sam Roberts, a correspondent for the New York Times and the author of a book about the historic train station, the dark residue that accumulated on the concourse ceiling over decades and was originally believed to be the result of soot from train engines was primarily residue from tobacco smoke [10–12]. It wasn’t until a restoration in the 1990s when workers scrubbed the tar and nicotine residue from the ceiling could the elaborate design of the zodiac signs and constellations be seen again [13]. A similar process takes place inside homes, where smoke residue accumulates on surfaces such as walls and ceilings after smoking happens. Owners of homes that have been previously smoked in are faced with unanswered questions about how to clean up the toxic substances left behind.
When tobacco is smoked, the particulates contained in secondhand smoke settle on surfaces; this contamination is absorbed deep into materials such as hair, clothes, carpeting, furniture, and wallboard [9,14]. After depositing onto surfaces, the chemicals undergo an aging process, which changes the chemical structure of the smoke pollutants. The nicotine in thirdhand smoke residue reacts with common indoor air pollutants, such as nitrous acid and ozone, to form hazardous substances. When the nicotine present in thirdhand smoke reacts with nitrous acid, it forms carcinogenic tobacco-specific nitrosamines such as NNK and NNN [15–17]. Nicotine also reacts with ozone to form additional harmful ultrafine particles that can embed deep within the lungs when inhaled [18]. As thirdhand smoke ages, it becomes more toxic [15]. The aged particles then undergo a process called “off-gassing,” in which gas is continuously re-emitted from these surfaces back into the air [19]. This process of off-gassing occurs long after cigarettes have been smoked indoors [19,20]. Thirdhand smoke particles can also be inhaled when they get resuspended into the air after contaminated surfaces are disturbed [21].
Common practices employed by smokers, like smoking in different rooms, using fans to diffuse the smoke, or opening windows, do not prevent the formation and inhalation of thirdhand smoke by people living or visiting these indoor spaces [22]. Environments with potential thirdhand smoke exposure include homes of smokers [23], apartments and homes previously occupied by smokers [24], multiunit housing where smoking is permitted [25], automobiles that have been smoked in [26], hotel rooms where smoking is permitted [27], and other indoor places where smoking has occurred.
Research Supports Having Completely Smoke-Free Environments
Recent research has shown that exposure to thirdhand smoke is harmful. These findings, many of which are described below, offer strong support in favor of advocating for environments free of thirdhand smoke contamination for families and children.
Genetic Damage from Thirdhand Smoke Exposure
In 2013, researchers from the Lawrence Berkeley National Laboratory were the first to demonstrate that thirdhand smoke causes significant genetic damage to human cells [28]. Using in vitro assays, the researchers showed that thirdhand smoke is a cause of harm to human DNA in the form of strand breaks and oxidative damage, which leads to mutations that can cause cancer. The researches also specifically tested the effect of NNA, a tobacco-specific nitrosamine that is commonly found in thirdhand smoke but not in secondhand smoke, on human cell cultures and found that it caused significant damage to DNA [28].
Children Show Elevated Biomarkers of Thirdhand Smoke Exposure in Their Urine and Hair Samples
In 2004, Matt and colleagues described how they collected household dust samples from living rooms and infants’ bedrooms [23]. Their research demonstrated that nicotine accumulated on the living room and infants’ bedroom surfaces of the homes belonging to smokers. Significantly higher amounts of urine cotinine, a biomarker for exposure to nicotine, were detected among infants who lived in homes where smoking happens inside compared to homes where smokers go outside to smoke [23]. As well, a study published in 2017 that measured the presence of hand nicotine on children of smokers who presented to the emergency room for an illness possibly related to tobacco smoke exposure detected hand nicotine on the hands of each child who participated in this pilot study. The researchers found a positive correlation between the amount of nicotine found on children’s hands and the amount of cotinine, a biomarker for nicotine exposure, detected in the children’s saliva [29].
Children Are Exposed to Higher Ratios of Thirdhand Smoke than Adults
In 2009, researchers discovered that the thirdhand smoke ratio of tobacco-specific nitrosamines to nicotine increases during the aging process [9]. Biomarkers measured in the urine can now be used to estimate the degree to which people have been exposed to secondhand or thirdhand smoke based on the ratio of the thirdhand smoke biomarker NNK and nicotine. Toddlers who live with adults who smoke have higher NNK/nicotine ratios, suggesting that they are exposed to a higher ratio of thirdhand smoke compared to secondhand smoke than adults [30]. Young children are likely exposed to higher ratios of thirdhand smoke as they spend more time on the floor, where thirdhand smoke accumulates. They frequently put their hands and other objects into their mouths. Young children breathe faster than adults, increasing their inhalation exposure and also have thinner skin, making dermal absorption more efficient [9].
Modeling Excess Cancer Risk
A 2014 United Kingdom study used official sources of toxicological data about chemicals detected in thirdhand smoke–contaminated homes to assess excess cancer risk posed from thirdhand smoke [17]. Using dust samples collected from homes where a smoker lived, they estimate that the median lifetime excess cancer risk from the exposure to all the nitrosamines present in thirdhand smoke is 9.6 additional cancer cases per 100,000 children exposed and could be as high as 1 excess cancer case per 1000 children exposed. The researchers concluded that young children aged 1 to 6 are at an especially increased risk for cancer because of their frequent contact with surfaces contaminated with thirdhand smoke and their ingestion of the particulate matter that settles on surfaces after smoking takes place [17].
Infants in Health Care Facilities Are Exposed to Thirdhand Smoke
Researchers have observed biomarkers confirming thirdhand smoke exposure in the urine of infants in the NICU. Found in incubators and cribs, particulates are likely being deposited in the NICU from visitors who have thirdhand smoke on their clothing, skin, and hair [31].
Animal Studies Link Thirdhand Smoke Exposure to Common Human Disease
Mice exposed to thirdhand smoke under conditions meant to simulate levels similar to human exposure are pre-diabetic, are at higher risk of developing metabolic syndrome, have inflammatory markers in the lungs that increase the risk for asthma, show slow wound healing, develop nonalcoholic fatty liver disease, and become behaviorally hyperactive [32]. Another recent study published in 2017 showed that mice exposed to thirdhand smoke after birth weighed less than mice not exposed to thirdhand smoke. Additionally, mice exposed to thirdhand smoke early in life showed changes in white blood cell counts that persisted into adulthood [9,33].
Summary
In summary, recent research makes a compelling case for invoking the precautionary principle to ensure that children avoid exposures to thirdhand smoke in their homes, cars, and healthcare settings. Studies reveal that:
- children live in homes where thirdhand smoke is present and this exposure is detectable in their bodies [23]
- concentrations of thirdhand smoke exposure observed in children are disproportionately higher than adults [30]
- chemicals present in thirdhand smoke cause damage to DNA [28]
- thirdhand smoke contains carcinogens that put exposed children at increased risk of cancer [17]
- thirdhand smoke is being detected within medical settings [34] and in the bodies of medically-vulnerable children [29], and
- animal studies have linked exposure to thirdhand smoke to a number of adverse health conditions commonly seen in today’s pediatric population such as metabolic syndrome, prediabetes, asthma, hyperactivity [32] and low birth weight [33].
Using the Thirdhand Smoke Concept in Clinical Practice
The clinical setting is an ideal place to address thirdhand smoke with families as a component of a comprehensive tobacco control strategy.
The Cessation Imperative—A Novel Motivational Message Prompted by Thirdhand Smoke
While there are potentially many ways to address thirdhand smoke exposure with families, the CEASE program has been used in the primary care setting to train child health care clinicians and office staff to address second- and thirdhand smoke. The training also educates clinicians on providing cessation counseling and resources to families with the goal of helping all family members become tobacco free, as well as to helping families keep completely smoke-free homes and cars [35,36]. The concept of thirdhand smoke creates what we have coined the cessation imperative [36]. The cessation imperative is based on the notion that the only way to protect non-smoking family and household members from thirdhand smoke is for all household smokers to quit smoking completely. Smoking, even when not in the presence of children, can expose others to toxic contaminates that settle on the surfaces of the home, the car as well as to the skin, hair, and clothing of family members who smoke. A discussion with parents about eliminating only secondhand smoke exposure for children does not adequately address how continued smoking, even when children are not present, can be harmful. The thirdhand smoke concept can be presented early, making it an efficient way to advocate for completely smoke-free families.
Thirdhand Smoke Counseling Helps Clinicians Achieve Key Tobacco Control Goals
The American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP) recommend that health care providers deliver advice to parents regarding establishing smoke-free homes and cars and provide information about how their smoking adversely affects their children’s health [37,38]. It is AAP and AAFP policy that health care providers provide tobacco dependence treatment and referral to cessation services to help adult family members quit smoking [38,39]. Successfully integrating counseling around the topic of thirdhand smoke into existing smoking cessation service delivery is possible. The CEASE research and implementation team developed and disseminated educational content to clinicians about thirdhand smoke through AAP courses delivered online [40] as well as made presentations to clinicians at AAP-sponsored training sessions. Thirdhand smoke messaging has been included in the CEASE practice trainings so that participating clinicians in pediatric offices are equipped to engage parents on this topic. Further information about these educational resources and opportunities can be obtained from the AAP Julius B. Richmond Center of Excellence website [41] and from the Massachusetts General Hospital CEASE program’s website [42].
Counseling parents about thirdhand smoke can help assist parents with their smoking in the critical context of their child’s care. Most parents see their child’s health care clinician more often than their own [43]. Increasing the number of pediatric clinical encounters where parental smoking is addressed while also increasing the effectiveness of these clinical encounters by increasing parents’ motivation to protect their children from tobacco smoke exposure are important goals. The topic of thirdhand smoke is a novel concept that clinicians can use to engage with parents around their smoking in a new way. Recent research conducted by the CEASE team suggests that counseling parents in the pediatric setting about thirdhand smoke can be useful in helping achieve tobacco control goals with families. Parent’s belief about thirdhand smoke is associated with the likelihood the parent will take concrete steps to protect their child. Parents who believe thirdhand smoke is harmful are more likely to protect their children from exposure by adopting strictly enforced smoke-free home and car rules [44]. Parents who changed their thirdhand smoke beliefs over the course of a year to believing that thirdhand smoke is harmful were more likely to try to quit smoking [44].
Child health care clinicians are effective at influencing parents’ beliefs about the potential harm thirdhand smoke poses to their children. Parents who received advice from pediatricians to quit smoking or to adopt smoke-free home or policies were more likely to believe that thirdhand smoke was harmful to the health of children [45]. Fathers (as compared with mothers) and parents who smoked more cigarettes each day were less likely to accept that thirdhand smoke is harmful to children [45]. Conversely, delivering effective educational messages and counseling around the topic of thirdhand smoke to parents may help promote smoke-free rules and acceptance of cessation assistance.
Protect Patients from Thirdhand Smoke Risks
All health care settings should be completely smoke-free. Smoking bans help protect all families and children from second and thirdhand smoke exposure. It is especially important for medically vulnerable children to visit facilities free from all forms of tobacco smoke contamination. CEASE trainings encourage practices to implement a zone of wellness on the grounds of the healthcare facility by completely banning smoking. The CEASE implementation team also trains practice leaders to reach out to all staff that use tobacco and offer resources and support for quitting. Having a non-smoking staff sets a great example for families who visit the healthcare facility, and reduces the likelihood of bringing thirdhand smoke contaminates into the facility. Creating a policy that addresses thirdhand smoke exposure is a concrete step that health care organizations can take to protect patients.
Thirdhand Smoke Resources Developed and/or Used by the CEASE Program
The CEASE program has developed and/or identified a number of clinical resources to educate parents and clinicians about thirdhand smoke. These free resources can enhance awareness of thirdhand smoke and help promote the use of the thirdhand smoke concept in clinical practice.
- Posters with messages designed to educate parents about thirdhand smoke to encourage receipt of cessation resources were created for use in waiting areas and exam rooms of child health care practices. A poster for clinical practice (Figure 1) can be downloaded and printed from the CEASE program website [42].
- Health education handouts that directly address thirdhand smoke exposure are available. The handouts can be taken home to family members who are not present at the visit and contain the telephone number for the tobacco quitline service, which connects smokers in the United States with free telephone support for smoking cessation. Handouts for clinical practice can be downloaded and printed from the CEASE program website. Figure 2 shows a handout that encourages parents to keep a smoke-free car by pointing out that tobacco smoke stays in the car long after the cigarette is out.
- Videos about thirdhand smoke can be viewed by parents while in child health care offices or shared on practice websites or social media platforms. The CEASE program encourages practices to distribute videos about thirdhand smoke to introduce parents to the concept of thirdhand smoke and to encourage parents to engage in a discussion with their child’s clinicians about ways to limit thirdhand smoke exposure. Suitable videos for parental viewing include the 2 listed below, which highlight information from the Thirdhand Smoke Research Consortium.
-University of California Riverside https://youtu.be/i1rhqRy-2e8
-San Diego State University https://youtu.be/rqzi-9sXLdU - Letters for landlords and management companies were created to stress the importance of providing a smoke-free living environment for children. The letters are meant to be signed by the child’s health care provider. The letters state that eliminating smoking in their buildings would result in landlords that “Pay less for cleaning and turnover fees.” Landlord letter templates can be downloaded and printed from the CEASE program website [42].
- Educational content for child health care clinicians about thirdhand smoke and how to counsel parents is included in the American Academy of Pediatrics Education in Quality Improvement for Pediatric Practice (EQIPP) online course entitled “Eliminating Tobacco” Use and Exposure to Secondhand Smoke. A section devoted to educating clinicians on the topic of thirdhand smoke is presented in this course. The course can be accessed through the AAP website and it qualifies for American Board of Pediatrics maintenance of certification part IV credit [40].
The CEASE team has worked with mass media outlets to communicate the messages about thirdhand smoke to build public awareness. The Today Show helped to popularize the concept of thirdhand smoke in 2009 after a paper published in the journal Pediatrics linked thirdhand smoke beliefs to home smoking bans [2].
Systems Approaches to Reduce Thirdhand Smoke Exposure
Public Policy Approaches
A clear policy agenda can help people protect their families from exposure to thirdhand smoke [46]. Policy approaches that have worked for lead, asbestos, and radon are examples of common household contaminants that are regulated using different mechanisms in an effort to protect the public health [46]. Strengths and weaknesses in each of these different approaches should be carefully considered when developing a comprehensive policy agenda to address thirdhand smoke. Recently, research on the health effects of thirdhand smoke spurred the passage of California legislative bill AB 1819 that “prohibits smoking tobacco at all times in the homes of licensed family child care homes and in areas where children are present [47].” As well, a recent US Department of Housing and Urban Development rule was finalized that requires all public housing agencies to implement a smoke-free policy by 30 July 2018 [48]. Smoke-free housing protects occupants from both secondhand and thirdhand smoke exposure. Pediatricians and other child health care professionals are well positioned to advocate for legislative actions that protect children from harmful exposures to thirdhand smoke.
Practice Change in Child Health Care Settings
Designing health care systems to screen for tobacco smoke exposure and to provide evidence-based cessation resources for all smokers is one of the best ways to reduce exposures to thirdhand smoke. Preventing thirdhand smoke exposure can work as novel messaging to promote tobacco cessation programs. Developing electronic medical record systems that allow for documentation of the smoking status of household members and whether or not homes and cars are completely smokefree can be particularly helpful tools for child health care providers when addressing thirdhand smoke with families. Good documentation about smoke-free homes and cars can enhance follow-up discussions with families as they work towards reducing thirdhand smoke exposures.
Summary
The thirdhand smoke concept has been used to improve delivery of tobacco control counseling and services for parents in the child health care context. Free materials are available that utilize thirdhand smoke messaging. As the science of thirdhand smoke matures, it will increasingly be used to help promote completely smoke-free places. The existing research on thirdhand smoke establishes the need for clinicians to communicate the cessation imperative. By using it, clinicians can help all smokers and non-smokers understand that there is no way to smoke tobacco without exposing friends and family.
Corresponding author: Jeremy E. Drehmer, MPH, 125 Nashua St., Suite 860, Boston, MA 02114, jdrehmer@ mgh.harvard.edu.
Financial disclosures: None
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From the Center for Child and Adolescent Health Research and Policy, Division of General Academic Pediatrics, Massachusetts General Hospital for Children, and the Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, MA.
Abstract
- Objective: To explain the concept of thirdhand smoke and how it can be used to protect the health of children and improve delivery of tobacco control interventions for parents in the child health care setting.
- Methods: Review of the literature and descriptive report.
- Results: The thirdhand smoke concept has been used in the CEASE intervention to improve the delivery of tobacco control counseling and services to parents. Materials and techniques have been developed for the child health care setting that use the concept of thirdhand smoke. Scientific findings demonstrate that thirdhand smoke exposure is harmful and establishes the need for clinicians to communicate the cessation imperative: the only way to protect non-smoking household members from thirdhand smoke is for all household smokers to quit smoking completely. As the scientific knowledge of thirdhand smoke increases, advocates will likely rely on it to encourage completely smoke-free places.
- Conclusion: Recent scientific studies on thirdhand smoke are impelling further research on the topic, spurring the creation of tobacco control policies to protect people from thridhand smoke and stimulating improvements to the delivery of tobacco control counseling and services to parents in child health care settings.
Key words: thirdhand smoke; smoking; tobacco; indoor air quality; smoking cessation; pediatrics.
While “thirdhand smoke” may be a relatively new term, it is rooted in an old concept—the particulate matter and residue from tobacco smoke left behind after tobacco is burned. In 1953, Dr. Ernest Wynder and his colleagues from the Washington University School of Medicine in St. Louis showed that condensate made from the residue of cigarette smoke causes cancer [1]. This residue left behind by burning cigarettes is now known as thirdhand smoke [2]. Dr. Wynder used acetone to rinse the leftover tobacco smoke residue from a smoking chamber where he had burned cigarettes. He then painted the solution of acetone and thirdhand smoke residue onto the backs of mice. The results of Dr. Wynder’s study demonstrated that exposed mice developed cancerous skin lesions, whereas mice exposed to the acetone alone did not display skin lesions. Dr. Wynder sounded an alarm bell in his manuscript when he wrote, “Such studies, in view of the corollary clinical data relating smoking to various types of cancer, appear urgent. They may result not only in furthering our knowledge of carcinogenesis, but in promoting some practical aspects of cancer prevention [1].”
Decades of research has been conducted since Dr. Wynder’s discovery to definitively conclude that smoking tobacco and exposure to secondhand tobacco smoke is harmful to human health. It is estimated that 480,000 annual premature deaths in the United States alone are attributable to smoking and exposure to secondhand smoke [3]. The World Health Organization estimates that worldwide tobacco use is responsible for more than 7 million deaths per year, with 890,000 of those deaths caused by secondhand smoke exposure of nonsmokers [4]. Epidemiological evidence of the harm posed by tobacco has spurred the U.S Surgeon General to conclude that there is no risk-free level of exposure to tobacco smoke [5]. Despite the overwhelming evidence implicating tobacco as the cause of an unprecedented amount of disease resulting from the use of a consumer product, only recently has a dedicated research agenda been pursued to study what Dr. Wynder urgently called for back in 1953: further exploration of the health effects of thirdhand tobacco smoke.
The term "thirdhand smoke" was first coined in 2006 by researchers with the Clinical Effort Against Secondhand Smoke Exposure (CEASE) program at Massachusetts General Hospital in Boston [6], and recent research has begun to shed considerable light on the topic. In 2011, a research consortium of scientists funded by the Tobacco-Related Disease Research Program [7] in California was set up to conduct pioneering research on the characterization, exposure and health effects of thirdhand tobacco smoke [8]. Research findings from this consortium and other scientists from around the world are quickly expanding and disseminating knowledge on this important topic.
While the research on thirdhand smoke is ongoing, this paper summarizes the current literature most relevant to the pediatric population and outlines clinical and policy recommendations to protect children and families from the harms of exposure to thirdhand smoke.
What Is Thirdhand Smoke and How Is It Different from Secondhand Smoke?
Thirdhand smoke is a result of combusted tobacco, most often from smoking cigarettes, pipes, cigars, or cigarillos. Thirdhand smoke remains on surfaces and in dust for a longtime after smoking happens, reacts with oxidants and other compounds to form secondary pollutants, and is re-emitted as a gas and/or resuspended when particles are disturbed and go back into the air where they can be inhaled [9]. One dramatic example of how thirdhand smoke can remain on surfaces long after secondhand smoke dissipates was discovered on the ornate constellation ceiling in the main concourse of the Grand Central Terminal in New York City. According to Sam Roberts, a correspondent for the New York Times and the author of a book about the historic train station, the dark residue that accumulated on the concourse ceiling over decades and was originally believed to be the result of soot from train engines was primarily residue from tobacco smoke [10–12]. It wasn’t until a restoration in the 1990s when workers scrubbed the tar and nicotine residue from the ceiling could the elaborate design of the zodiac signs and constellations be seen again [13]. A similar process takes place inside homes, where smoke residue accumulates on surfaces such as walls and ceilings after smoking happens. Owners of homes that have been previously smoked in are faced with unanswered questions about how to clean up the toxic substances left behind.
When tobacco is smoked, the particulates contained in secondhand smoke settle on surfaces; this contamination is absorbed deep into materials such as hair, clothes, carpeting, furniture, and wallboard [9,14]. After depositing onto surfaces, the chemicals undergo an aging process, which changes the chemical structure of the smoke pollutants. The nicotine in thirdhand smoke residue reacts with common indoor air pollutants, such as nitrous acid and ozone, to form hazardous substances. When the nicotine present in thirdhand smoke reacts with nitrous acid, it forms carcinogenic tobacco-specific nitrosamines such as NNK and NNN [15–17]. Nicotine also reacts with ozone to form additional harmful ultrafine particles that can embed deep within the lungs when inhaled [18]. As thirdhand smoke ages, it becomes more toxic [15]. The aged particles then undergo a process called “off-gassing,” in which gas is continuously re-emitted from these surfaces back into the air [19]. This process of off-gassing occurs long after cigarettes have been smoked indoors [19,20]. Thirdhand smoke particles can also be inhaled when they get resuspended into the air after contaminated surfaces are disturbed [21].
Common practices employed by smokers, like smoking in different rooms, using fans to diffuse the smoke, or opening windows, do not prevent the formation and inhalation of thirdhand smoke by people living or visiting these indoor spaces [22]. Environments with potential thirdhand smoke exposure include homes of smokers [23], apartments and homes previously occupied by smokers [24], multiunit housing where smoking is permitted [25], automobiles that have been smoked in [26], hotel rooms where smoking is permitted [27], and other indoor places where smoking has occurred.
Research Supports Having Completely Smoke-Free Environments
Recent research has shown that exposure to thirdhand smoke is harmful. These findings, many of which are described below, offer strong support in favor of advocating for environments free of thirdhand smoke contamination for families and children.
Genetic Damage from Thirdhand Smoke Exposure
In 2013, researchers from the Lawrence Berkeley National Laboratory were the first to demonstrate that thirdhand smoke causes significant genetic damage to human cells [28]. Using in vitro assays, the researchers showed that thirdhand smoke is a cause of harm to human DNA in the form of strand breaks and oxidative damage, which leads to mutations that can cause cancer. The researches also specifically tested the effect of NNA, a tobacco-specific nitrosamine that is commonly found in thirdhand smoke but not in secondhand smoke, on human cell cultures and found that it caused significant damage to DNA [28].
Children Show Elevated Biomarkers of Thirdhand Smoke Exposure in Their Urine and Hair Samples
In 2004, Matt and colleagues described how they collected household dust samples from living rooms and infants’ bedrooms [23]. Their research demonstrated that nicotine accumulated on the living room and infants’ bedroom surfaces of the homes belonging to smokers. Significantly higher amounts of urine cotinine, a biomarker for exposure to nicotine, were detected among infants who lived in homes where smoking happens inside compared to homes where smokers go outside to smoke [23]. As well, a study published in 2017 that measured the presence of hand nicotine on children of smokers who presented to the emergency room for an illness possibly related to tobacco smoke exposure detected hand nicotine on the hands of each child who participated in this pilot study. The researchers found a positive correlation between the amount of nicotine found on children’s hands and the amount of cotinine, a biomarker for nicotine exposure, detected in the children’s saliva [29].
Children Are Exposed to Higher Ratios of Thirdhand Smoke than Adults
In 2009, researchers discovered that the thirdhand smoke ratio of tobacco-specific nitrosamines to nicotine increases during the aging process [9]. Biomarkers measured in the urine can now be used to estimate the degree to which people have been exposed to secondhand or thirdhand smoke based on the ratio of the thirdhand smoke biomarker NNK and nicotine. Toddlers who live with adults who smoke have higher NNK/nicotine ratios, suggesting that they are exposed to a higher ratio of thirdhand smoke compared to secondhand smoke than adults [30]. Young children are likely exposed to higher ratios of thirdhand smoke as they spend more time on the floor, where thirdhand smoke accumulates. They frequently put their hands and other objects into their mouths. Young children breathe faster than adults, increasing their inhalation exposure and also have thinner skin, making dermal absorption more efficient [9].
Modeling Excess Cancer Risk
A 2014 United Kingdom study used official sources of toxicological data about chemicals detected in thirdhand smoke–contaminated homes to assess excess cancer risk posed from thirdhand smoke [17]. Using dust samples collected from homes where a smoker lived, they estimate that the median lifetime excess cancer risk from the exposure to all the nitrosamines present in thirdhand smoke is 9.6 additional cancer cases per 100,000 children exposed and could be as high as 1 excess cancer case per 1000 children exposed. The researchers concluded that young children aged 1 to 6 are at an especially increased risk for cancer because of their frequent contact with surfaces contaminated with thirdhand smoke and their ingestion of the particulate matter that settles on surfaces after smoking takes place [17].
Infants in Health Care Facilities Are Exposed to Thirdhand Smoke
Researchers have observed biomarkers confirming thirdhand smoke exposure in the urine of infants in the NICU. Found in incubators and cribs, particulates are likely being deposited in the NICU from visitors who have thirdhand smoke on their clothing, skin, and hair [31].
Animal Studies Link Thirdhand Smoke Exposure to Common Human Disease
Mice exposed to thirdhand smoke under conditions meant to simulate levels similar to human exposure are pre-diabetic, are at higher risk of developing metabolic syndrome, have inflammatory markers in the lungs that increase the risk for asthma, show slow wound healing, develop nonalcoholic fatty liver disease, and become behaviorally hyperactive [32]. Another recent study published in 2017 showed that mice exposed to thirdhand smoke after birth weighed less than mice not exposed to thirdhand smoke. Additionally, mice exposed to thirdhand smoke early in life showed changes in white blood cell counts that persisted into adulthood [9,33].
Summary
In summary, recent research makes a compelling case for invoking the precautionary principle to ensure that children avoid exposures to thirdhand smoke in their homes, cars, and healthcare settings. Studies reveal that:
- children live in homes where thirdhand smoke is present and this exposure is detectable in their bodies [23]
- concentrations of thirdhand smoke exposure observed in children are disproportionately higher than adults [30]
- chemicals present in thirdhand smoke cause damage to DNA [28]
- thirdhand smoke contains carcinogens that put exposed children at increased risk of cancer [17]
- thirdhand smoke is being detected within medical settings [34] and in the bodies of medically-vulnerable children [29], and
- animal studies have linked exposure to thirdhand smoke to a number of adverse health conditions commonly seen in today’s pediatric population such as metabolic syndrome, prediabetes, asthma, hyperactivity [32] and low birth weight [33].
Using the Thirdhand Smoke Concept in Clinical Practice
The clinical setting is an ideal place to address thirdhand smoke with families as a component of a comprehensive tobacco control strategy.
The Cessation Imperative—A Novel Motivational Message Prompted by Thirdhand Smoke
While there are potentially many ways to address thirdhand smoke exposure with families, the CEASE program has been used in the primary care setting to train child health care clinicians and office staff to address second- and thirdhand smoke. The training also educates clinicians on providing cessation counseling and resources to families with the goal of helping all family members become tobacco free, as well as to helping families keep completely smoke-free homes and cars [35,36]. The concept of thirdhand smoke creates what we have coined the cessation imperative [36]. The cessation imperative is based on the notion that the only way to protect non-smoking family and household members from thirdhand smoke is for all household smokers to quit smoking completely. Smoking, even when not in the presence of children, can expose others to toxic contaminates that settle on the surfaces of the home, the car as well as to the skin, hair, and clothing of family members who smoke. A discussion with parents about eliminating only secondhand smoke exposure for children does not adequately address how continued smoking, even when children are not present, can be harmful. The thirdhand smoke concept can be presented early, making it an efficient way to advocate for completely smoke-free families.
Thirdhand Smoke Counseling Helps Clinicians Achieve Key Tobacco Control Goals
The American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP) recommend that health care providers deliver advice to parents regarding establishing smoke-free homes and cars and provide information about how their smoking adversely affects their children’s health [37,38]. It is AAP and AAFP policy that health care providers provide tobacco dependence treatment and referral to cessation services to help adult family members quit smoking [38,39]. Successfully integrating counseling around the topic of thirdhand smoke into existing smoking cessation service delivery is possible. The CEASE research and implementation team developed and disseminated educational content to clinicians about thirdhand smoke through AAP courses delivered online [40] as well as made presentations to clinicians at AAP-sponsored training sessions. Thirdhand smoke messaging has been included in the CEASE practice trainings so that participating clinicians in pediatric offices are equipped to engage parents on this topic. Further information about these educational resources and opportunities can be obtained from the AAP Julius B. Richmond Center of Excellence website [41] and from the Massachusetts General Hospital CEASE program’s website [42].
Counseling parents about thirdhand smoke can help assist parents with their smoking in the critical context of their child’s care. Most parents see their child’s health care clinician more often than their own [43]. Increasing the number of pediatric clinical encounters where parental smoking is addressed while also increasing the effectiveness of these clinical encounters by increasing parents’ motivation to protect their children from tobacco smoke exposure are important goals. The topic of thirdhand smoke is a novel concept that clinicians can use to engage with parents around their smoking in a new way. Recent research conducted by the CEASE team suggests that counseling parents in the pediatric setting about thirdhand smoke can be useful in helping achieve tobacco control goals with families. Parent’s belief about thirdhand smoke is associated with the likelihood the parent will take concrete steps to protect their child. Parents who believe thirdhand smoke is harmful are more likely to protect their children from exposure by adopting strictly enforced smoke-free home and car rules [44]. Parents who changed their thirdhand smoke beliefs over the course of a year to believing that thirdhand smoke is harmful were more likely to try to quit smoking [44].
Child health care clinicians are effective at influencing parents’ beliefs about the potential harm thirdhand smoke poses to their children. Parents who received advice from pediatricians to quit smoking or to adopt smoke-free home or policies were more likely to believe that thirdhand smoke was harmful to the health of children [45]. Fathers (as compared with mothers) and parents who smoked more cigarettes each day were less likely to accept that thirdhand smoke is harmful to children [45]. Conversely, delivering effective educational messages and counseling around the topic of thirdhand smoke to parents may help promote smoke-free rules and acceptance of cessation assistance.
Protect Patients from Thirdhand Smoke Risks
All health care settings should be completely smoke-free. Smoking bans help protect all families and children from second and thirdhand smoke exposure. It is especially important for medically vulnerable children to visit facilities free from all forms of tobacco smoke contamination. CEASE trainings encourage practices to implement a zone of wellness on the grounds of the healthcare facility by completely banning smoking. The CEASE implementation team also trains practice leaders to reach out to all staff that use tobacco and offer resources and support for quitting. Having a non-smoking staff sets a great example for families who visit the healthcare facility, and reduces the likelihood of bringing thirdhand smoke contaminates into the facility. Creating a policy that addresses thirdhand smoke exposure is a concrete step that health care organizations can take to protect patients.
Thirdhand Smoke Resources Developed and/or Used by the CEASE Program
The CEASE program has developed and/or identified a number of clinical resources to educate parents and clinicians about thirdhand smoke. These free resources can enhance awareness of thirdhand smoke and help promote the use of the thirdhand smoke concept in clinical practice.
- Posters with messages designed to educate parents about thirdhand smoke to encourage receipt of cessation resources were created for use in waiting areas and exam rooms of child health care practices. A poster for clinical practice (Figure 1) can be downloaded and printed from the CEASE program website [42].
- Health education handouts that directly address thirdhand smoke exposure are available. The handouts can be taken home to family members who are not present at the visit and contain the telephone number for the tobacco quitline service, which connects smokers in the United States with free telephone support for smoking cessation. Handouts for clinical practice can be downloaded and printed from the CEASE program website. Figure 2 shows a handout that encourages parents to keep a smoke-free car by pointing out that tobacco smoke stays in the car long after the cigarette is out.
- Videos about thirdhand smoke can be viewed by parents while in child health care offices or shared on practice websites or social media platforms. The CEASE program encourages practices to distribute videos about thirdhand smoke to introduce parents to the concept of thirdhand smoke and to encourage parents to engage in a discussion with their child’s clinicians about ways to limit thirdhand smoke exposure. Suitable videos for parental viewing include the 2 listed below, which highlight information from the Thirdhand Smoke Research Consortium.
-University of California Riverside https://youtu.be/i1rhqRy-2e8
-San Diego State University https://youtu.be/rqzi-9sXLdU - Letters for landlords and management companies were created to stress the importance of providing a smoke-free living environment for children. The letters are meant to be signed by the child’s health care provider. The letters state that eliminating smoking in their buildings would result in landlords that “Pay less for cleaning and turnover fees.” Landlord letter templates can be downloaded and printed from the CEASE program website [42].
- Educational content for child health care clinicians about thirdhand smoke and how to counsel parents is included in the American Academy of Pediatrics Education in Quality Improvement for Pediatric Practice (EQIPP) online course entitled “Eliminating Tobacco” Use and Exposure to Secondhand Smoke. A section devoted to educating clinicians on the topic of thirdhand smoke is presented in this course. The course can be accessed through the AAP website and it qualifies for American Board of Pediatrics maintenance of certification part IV credit [40].
The CEASE team has worked with mass media outlets to communicate the messages about thirdhand smoke to build public awareness. The Today Show helped to popularize the concept of thirdhand smoke in 2009 after a paper published in the journal Pediatrics linked thirdhand smoke beliefs to home smoking bans [2].
Systems Approaches to Reduce Thirdhand Smoke Exposure
Public Policy Approaches
A clear policy agenda can help people protect their families from exposure to thirdhand smoke [46]. Policy approaches that have worked for lead, asbestos, and radon are examples of common household contaminants that are regulated using different mechanisms in an effort to protect the public health [46]. Strengths and weaknesses in each of these different approaches should be carefully considered when developing a comprehensive policy agenda to address thirdhand smoke. Recently, research on the health effects of thirdhand smoke spurred the passage of California legislative bill AB 1819 that “prohibits smoking tobacco at all times in the homes of licensed family child care homes and in areas where children are present [47].” As well, a recent US Department of Housing and Urban Development rule was finalized that requires all public housing agencies to implement a smoke-free policy by 30 July 2018 [48]. Smoke-free housing protects occupants from both secondhand and thirdhand smoke exposure. Pediatricians and other child health care professionals are well positioned to advocate for legislative actions that protect children from harmful exposures to thirdhand smoke.
Practice Change in Child Health Care Settings
Designing health care systems to screen for tobacco smoke exposure and to provide evidence-based cessation resources for all smokers is one of the best ways to reduce exposures to thirdhand smoke. Preventing thirdhand smoke exposure can work as novel messaging to promote tobacco cessation programs. Developing electronic medical record systems that allow for documentation of the smoking status of household members and whether or not homes and cars are completely smokefree can be particularly helpful tools for child health care providers when addressing thirdhand smoke with families. Good documentation about smoke-free homes and cars can enhance follow-up discussions with families as they work towards reducing thirdhand smoke exposures.
Summary
The thirdhand smoke concept has been used to improve delivery of tobacco control counseling and services for parents in the child health care context. Free materials are available that utilize thirdhand smoke messaging. As the science of thirdhand smoke matures, it will increasingly be used to help promote completely smoke-free places. The existing research on thirdhand smoke establishes the need for clinicians to communicate the cessation imperative. By using it, clinicians can help all smokers and non-smokers understand that there is no way to smoke tobacco without exposing friends and family.
Corresponding author: Jeremy E. Drehmer, MPH, 125 Nashua St., Suite 860, Boston, MA 02114, jdrehmer@ mgh.harvard.edu.
Financial disclosures: None
From the Center for Child and Adolescent Health Research and Policy, Division of General Academic Pediatrics, Massachusetts General Hospital for Children, and the Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, MA.
Abstract
- Objective: To explain the concept of thirdhand smoke and how it can be used to protect the health of children and improve delivery of tobacco control interventions for parents in the child health care setting.
- Methods: Review of the literature and descriptive report.
- Results: The thirdhand smoke concept has been used in the CEASE intervention to improve the delivery of tobacco control counseling and services to parents. Materials and techniques have been developed for the child health care setting that use the concept of thirdhand smoke. Scientific findings demonstrate that thirdhand smoke exposure is harmful and establishes the need for clinicians to communicate the cessation imperative: the only way to protect non-smoking household members from thirdhand smoke is for all household smokers to quit smoking completely. As the scientific knowledge of thirdhand smoke increases, advocates will likely rely on it to encourage completely smoke-free places.
- Conclusion: Recent scientific studies on thirdhand smoke are impelling further research on the topic, spurring the creation of tobacco control policies to protect people from thridhand smoke and stimulating improvements to the delivery of tobacco control counseling and services to parents in child health care settings.
Key words: thirdhand smoke; smoking; tobacco; indoor air quality; smoking cessation; pediatrics.
While “thirdhand smoke” may be a relatively new term, it is rooted in an old concept—the particulate matter and residue from tobacco smoke left behind after tobacco is burned. In 1953, Dr. Ernest Wynder and his colleagues from the Washington University School of Medicine in St. Louis showed that condensate made from the residue of cigarette smoke causes cancer [1]. This residue left behind by burning cigarettes is now known as thirdhand smoke [2]. Dr. Wynder used acetone to rinse the leftover tobacco smoke residue from a smoking chamber where he had burned cigarettes. He then painted the solution of acetone and thirdhand smoke residue onto the backs of mice. The results of Dr. Wynder’s study demonstrated that exposed mice developed cancerous skin lesions, whereas mice exposed to the acetone alone did not display skin lesions. Dr. Wynder sounded an alarm bell in his manuscript when he wrote, “Such studies, in view of the corollary clinical data relating smoking to various types of cancer, appear urgent. They may result not only in furthering our knowledge of carcinogenesis, but in promoting some practical aspects of cancer prevention [1].”
Decades of research has been conducted since Dr. Wynder’s discovery to definitively conclude that smoking tobacco and exposure to secondhand tobacco smoke is harmful to human health. It is estimated that 480,000 annual premature deaths in the United States alone are attributable to smoking and exposure to secondhand smoke [3]. The World Health Organization estimates that worldwide tobacco use is responsible for more than 7 million deaths per year, with 890,000 of those deaths caused by secondhand smoke exposure of nonsmokers [4]. Epidemiological evidence of the harm posed by tobacco has spurred the U.S Surgeon General to conclude that there is no risk-free level of exposure to tobacco smoke [5]. Despite the overwhelming evidence implicating tobacco as the cause of an unprecedented amount of disease resulting from the use of a consumer product, only recently has a dedicated research agenda been pursued to study what Dr. Wynder urgently called for back in 1953: further exploration of the health effects of thirdhand tobacco smoke.
The term "thirdhand smoke" was first coined in 2006 by researchers with the Clinical Effort Against Secondhand Smoke Exposure (CEASE) program at Massachusetts General Hospital in Boston [6], and recent research has begun to shed considerable light on the topic. In 2011, a research consortium of scientists funded by the Tobacco-Related Disease Research Program [7] in California was set up to conduct pioneering research on the characterization, exposure and health effects of thirdhand tobacco smoke [8]. Research findings from this consortium and other scientists from around the world are quickly expanding and disseminating knowledge on this important topic.
While the research on thirdhand smoke is ongoing, this paper summarizes the current literature most relevant to the pediatric population and outlines clinical and policy recommendations to protect children and families from the harms of exposure to thirdhand smoke.
What Is Thirdhand Smoke and How Is It Different from Secondhand Smoke?
Thirdhand smoke is a result of combusted tobacco, most often from smoking cigarettes, pipes, cigars, or cigarillos. Thirdhand smoke remains on surfaces and in dust for a longtime after smoking happens, reacts with oxidants and other compounds to form secondary pollutants, and is re-emitted as a gas and/or resuspended when particles are disturbed and go back into the air where they can be inhaled [9]. One dramatic example of how thirdhand smoke can remain on surfaces long after secondhand smoke dissipates was discovered on the ornate constellation ceiling in the main concourse of the Grand Central Terminal in New York City. According to Sam Roberts, a correspondent for the New York Times and the author of a book about the historic train station, the dark residue that accumulated on the concourse ceiling over decades and was originally believed to be the result of soot from train engines was primarily residue from tobacco smoke [10–12]. It wasn’t until a restoration in the 1990s when workers scrubbed the tar and nicotine residue from the ceiling could the elaborate design of the zodiac signs and constellations be seen again [13]. A similar process takes place inside homes, where smoke residue accumulates on surfaces such as walls and ceilings after smoking happens. Owners of homes that have been previously smoked in are faced with unanswered questions about how to clean up the toxic substances left behind.
When tobacco is smoked, the particulates contained in secondhand smoke settle on surfaces; this contamination is absorbed deep into materials such as hair, clothes, carpeting, furniture, and wallboard [9,14]. After depositing onto surfaces, the chemicals undergo an aging process, which changes the chemical structure of the smoke pollutants. The nicotine in thirdhand smoke residue reacts with common indoor air pollutants, such as nitrous acid and ozone, to form hazardous substances. When the nicotine present in thirdhand smoke reacts with nitrous acid, it forms carcinogenic tobacco-specific nitrosamines such as NNK and NNN [15–17]. Nicotine also reacts with ozone to form additional harmful ultrafine particles that can embed deep within the lungs when inhaled [18]. As thirdhand smoke ages, it becomes more toxic [15]. The aged particles then undergo a process called “off-gassing,” in which gas is continuously re-emitted from these surfaces back into the air [19]. This process of off-gassing occurs long after cigarettes have been smoked indoors [19,20]. Thirdhand smoke particles can also be inhaled when they get resuspended into the air after contaminated surfaces are disturbed [21].
Common practices employed by smokers, like smoking in different rooms, using fans to diffuse the smoke, or opening windows, do not prevent the formation and inhalation of thirdhand smoke by people living or visiting these indoor spaces [22]. Environments with potential thirdhand smoke exposure include homes of smokers [23], apartments and homes previously occupied by smokers [24], multiunit housing where smoking is permitted [25], automobiles that have been smoked in [26], hotel rooms where smoking is permitted [27], and other indoor places where smoking has occurred.
Research Supports Having Completely Smoke-Free Environments
Recent research has shown that exposure to thirdhand smoke is harmful. These findings, many of which are described below, offer strong support in favor of advocating for environments free of thirdhand smoke contamination for families and children.
Genetic Damage from Thirdhand Smoke Exposure
In 2013, researchers from the Lawrence Berkeley National Laboratory were the first to demonstrate that thirdhand smoke causes significant genetic damage to human cells [28]. Using in vitro assays, the researchers showed that thirdhand smoke is a cause of harm to human DNA in the form of strand breaks and oxidative damage, which leads to mutations that can cause cancer. The researches also specifically tested the effect of NNA, a tobacco-specific nitrosamine that is commonly found in thirdhand smoke but not in secondhand smoke, on human cell cultures and found that it caused significant damage to DNA [28].
Children Show Elevated Biomarkers of Thirdhand Smoke Exposure in Their Urine and Hair Samples
In 2004, Matt and colleagues described how they collected household dust samples from living rooms and infants’ bedrooms [23]. Their research demonstrated that nicotine accumulated on the living room and infants’ bedroom surfaces of the homes belonging to smokers. Significantly higher amounts of urine cotinine, a biomarker for exposure to nicotine, were detected among infants who lived in homes where smoking happens inside compared to homes where smokers go outside to smoke [23]. As well, a study published in 2017 that measured the presence of hand nicotine on children of smokers who presented to the emergency room for an illness possibly related to tobacco smoke exposure detected hand nicotine on the hands of each child who participated in this pilot study. The researchers found a positive correlation between the amount of nicotine found on children’s hands and the amount of cotinine, a biomarker for nicotine exposure, detected in the children’s saliva [29].
Children Are Exposed to Higher Ratios of Thirdhand Smoke than Adults
In 2009, researchers discovered that the thirdhand smoke ratio of tobacco-specific nitrosamines to nicotine increases during the aging process [9]. Biomarkers measured in the urine can now be used to estimate the degree to which people have been exposed to secondhand or thirdhand smoke based on the ratio of the thirdhand smoke biomarker NNK and nicotine. Toddlers who live with adults who smoke have higher NNK/nicotine ratios, suggesting that they are exposed to a higher ratio of thirdhand smoke compared to secondhand smoke than adults [30]. Young children are likely exposed to higher ratios of thirdhand smoke as they spend more time on the floor, where thirdhand smoke accumulates. They frequently put their hands and other objects into their mouths. Young children breathe faster than adults, increasing their inhalation exposure and also have thinner skin, making dermal absorption more efficient [9].
Modeling Excess Cancer Risk
A 2014 United Kingdom study used official sources of toxicological data about chemicals detected in thirdhand smoke–contaminated homes to assess excess cancer risk posed from thirdhand smoke [17]. Using dust samples collected from homes where a smoker lived, they estimate that the median lifetime excess cancer risk from the exposure to all the nitrosamines present in thirdhand smoke is 9.6 additional cancer cases per 100,000 children exposed and could be as high as 1 excess cancer case per 1000 children exposed. The researchers concluded that young children aged 1 to 6 are at an especially increased risk for cancer because of their frequent contact with surfaces contaminated with thirdhand smoke and their ingestion of the particulate matter that settles on surfaces after smoking takes place [17].
Infants in Health Care Facilities Are Exposed to Thirdhand Smoke
Researchers have observed biomarkers confirming thirdhand smoke exposure in the urine of infants in the NICU. Found in incubators and cribs, particulates are likely being deposited in the NICU from visitors who have thirdhand smoke on their clothing, skin, and hair [31].
Animal Studies Link Thirdhand Smoke Exposure to Common Human Disease
Mice exposed to thirdhand smoke under conditions meant to simulate levels similar to human exposure are pre-diabetic, are at higher risk of developing metabolic syndrome, have inflammatory markers in the lungs that increase the risk for asthma, show slow wound healing, develop nonalcoholic fatty liver disease, and become behaviorally hyperactive [32]. Another recent study published in 2017 showed that mice exposed to thirdhand smoke after birth weighed less than mice not exposed to thirdhand smoke. Additionally, mice exposed to thirdhand smoke early in life showed changes in white blood cell counts that persisted into adulthood [9,33].
Summary
In summary, recent research makes a compelling case for invoking the precautionary principle to ensure that children avoid exposures to thirdhand smoke in their homes, cars, and healthcare settings. Studies reveal that:
- children live in homes where thirdhand smoke is present and this exposure is detectable in their bodies [23]
- concentrations of thirdhand smoke exposure observed in children are disproportionately higher than adults [30]
- chemicals present in thirdhand smoke cause damage to DNA [28]
- thirdhand smoke contains carcinogens that put exposed children at increased risk of cancer [17]
- thirdhand smoke is being detected within medical settings [34] and in the bodies of medically-vulnerable children [29], and
- animal studies have linked exposure to thirdhand smoke to a number of adverse health conditions commonly seen in today’s pediatric population such as metabolic syndrome, prediabetes, asthma, hyperactivity [32] and low birth weight [33].
Using the Thirdhand Smoke Concept in Clinical Practice
The clinical setting is an ideal place to address thirdhand smoke with families as a component of a comprehensive tobacco control strategy.
The Cessation Imperative—A Novel Motivational Message Prompted by Thirdhand Smoke
While there are potentially many ways to address thirdhand smoke exposure with families, the CEASE program has been used in the primary care setting to train child health care clinicians and office staff to address second- and thirdhand smoke. The training also educates clinicians on providing cessation counseling and resources to families with the goal of helping all family members become tobacco free, as well as to helping families keep completely smoke-free homes and cars [35,36]. The concept of thirdhand smoke creates what we have coined the cessation imperative [36]. The cessation imperative is based on the notion that the only way to protect non-smoking family and household members from thirdhand smoke is for all household smokers to quit smoking completely. Smoking, even when not in the presence of children, can expose others to toxic contaminates that settle on the surfaces of the home, the car as well as to the skin, hair, and clothing of family members who smoke. A discussion with parents about eliminating only secondhand smoke exposure for children does not adequately address how continued smoking, even when children are not present, can be harmful. The thirdhand smoke concept can be presented early, making it an efficient way to advocate for completely smoke-free families.
Thirdhand Smoke Counseling Helps Clinicians Achieve Key Tobacco Control Goals
The American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP) recommend that health care providers deliver advice to parents regarding establishing smoke-free homes and cars and provide information about how their smoking adversely affects their children’s health [37,38]. It is AAP and AAFP policy that health care providers provide tobacco dependence treatment and referral to cessation services to help adult family members quit smoking [38,39]. Successfully integrating counseling around the topic of thirdhand smoke into existing smoking cessation service delivery is possible. The CEASE research and implementation team developed and disseminated educational content to clinicians about thirdhand smoke through AAP courses delivered online [40] as well as made presentations to clinicians at AAP-sponsored training sessions. Thirdhand smoke messaging has been included in the CEASE practice trainings so that participating clinicians in pediatric offices are equipped to engage parents on this topic. Further information about these educational resources and opportunities can be obtained from the AAP Julius B. Richmond Center of Excellence website [41] and from the Massachusetts General Hospital CEASE program’s website [42].
Counseling parents about thirdhand smoke can help assist parents with their smoking in the critical context of their child’s care. Most parents see their child’s health care clinician more often than their own [43]. Increasing the number of pediatric clinical encounters where parental smoking is addressed while also increasing the effectiveness of these clinical encounters by increasing parents’ motivation to protect their children from tobacco smoke exposure are important goals. The topic of thirdhand smoke is a novel concept that clinicians can use to engage with parents around their smoking in a new way. Recent research conducted by the CEASE team suggests that counseling parents in the pediatric setting about thirdhand smoke can be useful in helping achieve tobacco control goals with families. Parent’s belief about thirdhand smoke is associated with the likelihood the parent will take concrete steps to protect their child. Parents who believe thirdhand smoke is harmful are more likely to protect their children from exposure by adopting strictly enforced smoke-free home and car rules [44]. Parents who changed their thirdhand smoke beliefs over the course of a year to believing that thirdhand smoke is harmful were more likely to try to quit smoking [44].
Child health care clinicians are effective at influencing parents’ beliefs about the potential harm thirdhand smoke poses to their children. Parents who received advice from pediatricians to quit smoking or to adopt smoke-free home or policies were more likely to believe that thirdhand smoke was harmful to the health of children [45]. Fathers (as compared with mothers) and parents who smoked more cigarettes each day were less likely to accept that thirdhand smoke is harmful to children [45]. Conversely, delivering effective educational messages and counseling around the topic of thirdhand smoke to parents may help promote smoke-free rules and acceptance of cessation assistance.
Protect Patients from Thirdhand Smoke Risks
All health care settings should be completely smoke-free. Smoking bans help protect all families and children from second and thirdhand smoke exposure. It is especially important for medically vulnerable children to visit facilities free from all forms of tobacco smoke contamination. CEASE trainings encourage practices to implement a zone of wellness on the grounds of the healthcare facility by completely banning smoking. The CEASE implementation team also trains practice leaders to reach out to all staff that use tobacco and offer resources and support for quitting. Having a non-smoking staff sets a great example for families who visit the healthcare facility, and reduces the likelihood of bringing thirdhand smoke contaminates into the facility. Creating a policy that addresses thirdhand smoke exposure is a concrete step that health care organizations can take to protect patients.
Thirdhand Smoke Resources Developed and/or Used by the CEASE Program
The CEASE program has developed and/or identified a number of clinical resources to educate parents and clinicians about thirdhand smoke. These free resources can enhance awareness of thirdhand smoke and help promote the use of the thirdhand smoke concept in clinical practice.
- Posters with messages designed to educate parents about thirdhand smoke to encourage receipt of cessation resources were created for use in waiting areas and exam rooms of child health care practices. A poster for clinical practice (Figure 1) can be downloaded and printed from the CEASE program website [42].
- Health education handouts that directly address thirdhand smoke exposure are available. The handouts can be taken home to family members who are not present at the visit and contain the telephone number for the tobacco quitline service, which connects smokers in the United States with free telephone support for smoking cessation. Handouts for clinical practice can be downloaded and printed from the CEASE program website. Figure 2 shows a handout that encourages parents to keep a smoke-free car by pointing out that tobacco smoke stays in the car long after the cigarette is out.
- Videos about thirdhand smoke can be viewed by parents while in child health care offices or shared on practice websites or social media platforms. The CEASE program encourages practices to distribute videos about thirdhand smoke to introduce parents to the concept of thirdhand smoke and to encourage parents to engage in a discussion with their child’s clinicians about ways to limit thirdhand smoke exposure. Suitable videos for parental viewing include the 2 listed below, which highlight information from the Thirdhand Smoke Research Consortium.
-University of California Riverside https://youtu.be/i1rhqRy-2e8
-San Diego State University https://youtu.be/rqzi-9sXLdU - Letters for landlords and management companies were created to stress the importance of providing a smoke-free living environment for children. The letters are meant to be signed by the child’s health care provider. The letters state that eliminating smoking in their buildings would result in landlords that “Pay less for cleaning and turnover fees.” Landlord letter templates can be downloaded and printed from the CEASE program website [42].
- Educational content for child health care clinicians about thirdhand smoke and how to counsel parents is included in the American Academy of Pediatrics Education in Quality Improvement for Pediatric Practice (EQIPP) online course entitled “Eliminating Tobacco” Use and Exposure to Secondhand Smoke. A section devoted to educating clinicians on the topic of thirdhand smoke is presented in this course. The course can be accessed through the AAP website and it qualifies for American Board of Pediatrics maintenance of certification part IV credit [40].
The CEASE team has worked with mass media outlets to communicate the messages about thirdhand smoke to build public awareness. The Today Show helped to popularize the concept of thirdhand smoke in 2009 after a paper published in the journal Pediatrics linked thirdhand smoke beliefs to home smoking bans [2].
Systems Approaches to Reduce Thirdhand Smoke Exposure
Public Policy Approaches
A clear policy agenda can help people protect their families from exposure to thirdhand smoke [46]. Policy approaches that have worked for lead, asbestos, and radon are examples of common household contaminants that are regulated using different mechanisms in an effort to protect the public health [46]. Strengths and weaknesses in each of these different approaches should be carefully considered when developing a comprehensive policy agenda to address thirdhand smoke. Recently, research on the health effects of thirdhand smoke spurred the passage of California legislative bill AB 1819 that “prohibits smoking tobacco at all times in the homes of licensed family child care homes and in areas where children are present [47].” As well, a recent US Department of Housing and Urban Development rule was finalized that requires all public housing agencies to implement a smoke-free policy by 30 July 2018 [48]. Smoke-free housing protects occupants from both secondhand and thirdhand smoke exposure. Pediatricians and other child health care professionals are well positioned to advocate for legislative actions that protect children from harmful exposures to thirdhand smoke.
Practice Change in Child Health Care Settings
Designing health care systems to screen for tobacco smoke exposure and to provide evidence-based cessation resources for all smokers is one of the best ways to reduce exposures to thirdhand smoke. Preventing thirdhand smoke exposure can work as novel messaging to promote tobacco cessation programs. Developing electronic medical record systems that allow for documentation of the smoking status of household members and whether or not homes and cars are completely smokefree can be particularly helpful tools for child health care providers when addressing thirdhand smoke with families. Good documentation about smoke-free homes and cars can enhance follow-up discussions with families as they work towards reducing thirdhand smoke exposures.
Summary
The thirdhand smoke concept has been used to improve delivery of tobacco control counseling and services for parents in the child health care context. Free materials are available that utilize thirdhand smoke messaging. As the science of thirdhand smoke matures, it will increasingly be used to help promote completely smoke-free places. The existing research on thirdhand smoke establishes the need for clinicians to communicate the cessation imperative. By using it, clinicians can help all smokers and non-smokers understand that there is no way to smoke tobacco without exposing friends and family.
Corresponding author: Jeremy E. Drehmer, MPH, 125 Nashua St., Suite 860, Boston, MA 02114, jdrehmer@ mgh.harvard.edu.
Financial disclosures: None
1. Wynder EL, Graham EA, Croninger AB, et al. Experimental production of carcinoma with cigarette tar experimental production of carcinoma with cigarette tar. 1953;36:855–64.
2. Winickoff JP, Friebely J, Tanski SE, et al. Beliefs about the health effects of “thirdhand” smoke and home smoking bans. Pediatrics 2009;123:e74–9.
3. US Department of Health and Human Services. The health consequences of smoking- 50 years of progress: a report of the Surgeon General, Executive Summary. 2014.
4. World Health Organization. Tobacco fact sheet [Internet]. [cited 2017 Aug 15]. Available at www.who.int/mediacentre/factsheets/fs339/en/.
5. U.S. Department of Health and Human Services. The health consequences of involuntary exposure to tobacco smoke: a report of the Surgeon General. Atlanta (GA); 2006.
6. Winickoff J, Friebely J, Tanski S, et al. Beliefs about the health effects of third-hand smoke predict home and car smoking bans. In: Poster presented at the 2006 Pediatric Academic Societies Meeting. San Francisco, CA; 2006.
7. Tobacco-Related Disease Research Program [Internet]. Accessed 2017 Jul 7 at www.trdrp.org.
8. Matt GE, Quintana PJ, Destaillats H, et al. Thirdhand tobacco smoke: emerging evidence and arguments for a multidisciplinary research agenda. Environ Health Perspect 2011;119:1218–26.
9. Jacob P, Benowitz NL, Destaillats H, et al. Thirdhand smoke: new evidence, challenges, and future directions. Chem Res Toxicol 2017;30:270–94.
10. Roberts S, Hamill P. Grand Central: how a train station transformed America. Grand Central Publishing; 2013.
11. Sachs S. From gritty depot, a glittery destination; refurbished Grand Central terminal, worthy of its name, is reopened. New York Times 1998 Oct 2.
12. Grand Central: an engine of scientific innovation [Internet]. National Public Radio - Talk of the Nation; 2013. Available at www.npr.org/templates/transcript/transcript.php?storyId=175054273.
13. Lueck TJ. Work starts 100 feet above Grand Central commuters. New York Times 1996 Sep 20.
14. Van Loy MD, Nazaroff WW, Daisey JM. Nicotine as a marker for environmental tobacco smoke: implications of sorption on indoor surface materials. J Air Waste Manag Assoc 1998;48:959–68.
15. Sleiman M, Gundel LA, Pankow JF, et al. Formation of carcinogens indoors by surface-mediated reactions of nicotine with nitrous acid, leading to potential thirdhand smoke hazards. Proc Natl Acad Sci U S A 2010;107:6576–81.
16. Xue J, Yang S, Seng S. Mechanisms of cancer induction by tobacco-specific NNK and NNN. Cancers (Basel) 2014;6:1138–56.
17. Ramirez N, Ozel MZ, Lewis AC, et al. Exposure to nitrosamines in thirdhand tobacco smoke increases cancer risk in non-smokers. Environ Int 2014;71:139–47.
18. Destaillats H, Singer BC, Lee SK, Gundel LA. Effect of ozone on nicotine desorption from model surfaces: evidence for heterogeneous chemistry. Environ Sci Technol 2006;40:1799–805.
19. Singer BC, Hodgson AT, Guevarra KS, et al. Gas-phase organics in environmental tobacco smoke. 1. Effects of smoking rate, ventilation, and furnishing level on emission factors. Env Sci Technol 2002;36:846–53.
20. Singer BC, Hodgson AT, Nazaroff WW. Gas-phase organics in environmental tobacco smoke: 2. Exposure-relevant emission factors and indirect exposures from habitual smoking. Atmos Environ 2003;37:5551–61.
21. Becquemin MH, Bertholon JF, Bentayeb M, et al. Third-hand smoking: indoor measurements of concentration and sizes of cigarette smoke particles after resuspension. Tob Control 2010;19:347–8.
22. Centers for Disease Control and Prevention [Internet]. How can we protect our children from secondhand smoke: a parent’s guide. Accessed 2017 Aug 15 at www.cdc.gov/tobacco/basic_information/secondhand_smoke/protect_children/pdfs/protect_children_guide.pdf.
23. Matt GE, Quintana PJ, Hovell MF, et al. Households contaminated by environmental tobacco smoke: sources of infant exposures. Tob Control 2004;13:29–37.
24. Matt GE, Quintana PJE, Zakarian JM, et al. When smokers move out and non-smokers move in: residential thirdhand smoke pollution and exposure. Tob Control 2011;20:e1.
25. Kraev TA, Adamkiewicz G, Hammond SK, Spengler JD. Indoor concentrations of nicotine in low-income, multi-unit housing: associations with smoking behaviours and housing characteristics. Tob Control 2009;18:438–44.
26. Matt GE, Quintana PJE, Hovell MF, et al. Residual tobacco smoke pollution in used cars for sale: air, dust, and surfaces. Nicotine Tob Res 2008;10:1467–75.
27. Matt GE, Quintana PJE, Fortmann AL, et al. Thirdhand smoke and exposure in California hotels: non-smoking rooms fail to protect non-smoking hotel guests from tobacco smoke exposure. Tob Control 2014;23:264–72.
28. Hang B, Sarker AH, Havel C, et al. Thirdhand smoke causes DNA damage in human cells. Mutagenesis 2013;28:381–91.
29. Mahabee-Gittens EM, Merianos AL, Matt GE. Preliminary evidence that high levels of nicotine on children’s hands may contribute to overall tobacco smoke exposure. Tob Control 2017 Mar 30.
30. Hovell MF, Zakarian JM, Matt GE, et al. Counseling to reduce children’s secondhand smoke exposure and help parents quit smoking: a controlled trial. Nicotine Tob Res 2009;11:1383–94.
31. Northrup TF, Khan AM, Jacob 3rd P, et al. Thirdhand smoke contamination in hospital settings: assessing exposure risk for vulnerable paediatric patients. Tob Control 2016; 25: 619–23.
32. Martins-Green M, Adhami N, Frankos M, et al. Cigarette smoke toxins deposited on surfaces: Implications for human health. PLoS One 2014;9:1–12.
33. Hang B, Snijders AM, Huang Y, et al. Early exposure to thirdhand cigarette smoke affects body mass and the development of immunity in mice. Sci Rep 2017;7:41915.
34. Northrup TF, Matt GE, Hovell MF, et al. Thirdhand smoke in the homes of medically fragile children: Assessing the impact of indoor smoking levels and smoking bans. Nicotine Tob Res 2016;18:1290–8.
35. Marbin JN, Purdy CN, Klaas K, et al. The Clinical Effort against Secondhand Smoke Exposure (CEASE) California: implementing a pediatric clinical intervention to reduce secondhand smoke exposure. Clin Pediatr (Phila) 2016;1(3).
36. Winickoff JP, Hipple B, Drehmer J, et al. The Clinical Effort Against Secondhand Smoke Exposure (CEASE) intervention: A decade of lessons learned. J Clin Outcomes Manag 2012;19:414–9.
37. Farber HJ, Groner J, Walley S, Nelson K. Protecting children from tobacco, nicotine, and tobacco smoke. Pediatrics 2015;136:e1439–67.
38. American Academy of Family Physicians [Internet]. AAFP policies. Tobacco use, prevention, and cessation. Accessed 2017 Aug 29 at www.aafp.org/about/policies/all/tobacco-smoking.html.
39. Farber HJ, Walley SC, Groner JA, et al. Clinical practice policy to protect children from tobacco, nicotine, and tobacco smoke. Pediatrics 2015;136:1008–17.
40. Drehmer J, Hipple B, Murphy S, Winickoff JP. EQIPP: Eliminating tobacco use and exposure to secondhand smoke [online course] PediaLink [Internet]. American Academy of Pediatrics. 2014. Available at bit.ly/eliminate-tobacco-responsive.
41. The American Academy of Pediatrics Julius B. Richmond Center of Excellence [Internet]. Accessed 2017 Aug 9 at www.aap.org/en-us/advocacy-and-policy/aap-health-initiatives/Richmond-Center/Pages/default.aspx.
42. Clinical Effort Against Secondhand Smoke Exposure [Internet]. Accessed at www.massgeneral.org/ceasetobacco/.
43. Winickoff JP, Nabi-Burza E, Chang Y, et al. Implementation of a parental tobacco control intervention in pediatric practice. Pediatrics 2013;132:109–17.
44. Drehmer JE, Ossip DJ, Nabi-Burza E, et al. Thirdhand smoke beliefs of parents. Pediatrics 2014;133:e850–6.
45. Drehmer JE, Ossip DJ, Rigotti NA, et al. Pediatrician interventions and thirdhand smoke beliefs of parents. Am J Prev Med 2012;43:533–6.
46. Samet JM, Chanson D, Wipfli H. The challenges of limiting exposure to THS in vulnerable populations. Curr Environ Health Rep 2015;2:215–25.
47. Thirdhand Smoke Research Consortium [Internet]. Accessed 2017 Aug 15 at www.trdrp.org/highlights-news-events/thirdhand-smoke-consortium.html.
48. Office of the Federal Register (US) [Internet]. Rule instituting smoke-free public housing. 2016. Available at www.federalregister.gov/documents/2016/12/05/2016-28986/instituting-smoke-free-public-housing.
1. Wynder EL, Graham EA, Croninger AB, et al. Experimental production of carcinoma with cigarette tar experimental production of carcinoma with cigarette tar. 1953;36:855–64.
2. Winickoff JP, Friebely J, Tanski SE, et al. Beliefs about the health effects of “thirdhand” smoke and home smoking bans. Pediatrics 2009;123:e74–9.
3. US Department of Health and Human Services. The health consequences of smoking- 50 years of progress: a report of the Surgeon General, Executive Summary. 2014.
4. World Health Organization. Tobacco fact sheet [Internet]. [cited 2017 Aug 15]. Available at www.who.int/mediacentre/factsheets/fs339/en/.
5. U.S. Department of Health and Human Services. The health consequences of involuntary exposure to tobacco smoke: a report of the Surgeon General. Atlanta (GA); 2006.
6. Winickoff J, Friebely J, Tanski S, et al. Beliefs about the health effects of third-hand smoke predict home and car smoking bans. In: Poster presented at the 2006 Pediatric Academic Societies Meeting. San Francisco, CA; 2006.
7. Tobacco-Related Disease Research Program [Internet]. Accessed 2017 Jul 7 at www.trdrp.org.
8. Matt GE, Quintana PJ, Destaillats H, et al. Thirdhand tobacco smoke: emerging evidence and arguments for a multidisciplinary research agenda. Environ Health Perspect 2011;119:1218–26.
9. Jacob P, Benowitz NL, Destaillats H, et al. Thirdhand smoke: new evidence, challenges, and future directions. Chem Res Toxicol 2017;30:270–94.
10. Roberts S, Hamill P. Grand Central: how a train station transformed America. Grand Central Publishing; 2013.
11. Sachs S. From gritty depot, a glittery destination; refurbished Grand Central terminal, worthy of its name, is reopened. New York Times 1998 Oct 2.
12. Grand Central: an engine of scientific innovation [Internet]. National Public Radio - Talk of the Nation; 2013. Available at www.npr.org/templates/transcript/transcript.php?storyId=175054273.
13. Lueck TJ. Work starts 100 feet above Grand Central commuters. New York Times 1996 Sep 20.
14. Van Loy MD, Nazaroff WW, Daisey JM. Nicotine as a marker for environmental tobacco smoke: implications of sorption on indoor surface materials. J Air Waste Manag Assoc 1998;48:959–68.
15. Sleiman M, Gundel LA, Pankow JF, et al. Formation of carcinogens indoors by surface-mediated reactions of nicotine with nitrous acid, leading to potential thirdhand smoke hazards. Proc Natl Acad Sci U S A 2010;107:6576–81.
16. Xue J, Yang S, Seng S. Mechanisms of cancer induction by tobacco-specific NNK and NNN. Cancers (Basel) 2014;6:1138–56.
17. Ramirez N, Ozel MZ, Lewis AC, et al. Exposure to nitrosamines in thirdhand tobacco smoke increases cancer risk in non-smokers. Environ Int 2014;71:139–47.
18. Destaillats H, Singer BC, Lee SK, Gundel LA. Effect of ozone on nicotine desorption from model surfaces: evidence for heterogeneous chemistry. Environ Sci Technol 2006;40:1799–805.
19. Singer BC, Hodgson AT, Guevarra KS, et al. Gas-phase organics in environmental tobacco smoke. 1. Effects of smoking rate, ventilation, and furnishing level on emission factors. Env Sci Technol 2002;36:846–53.
20. Singer BC, Hodgson AT, Nazaroff WW. Gas-phase organics in environmental tobacco smoke: 2. Exposure-relevant emission factors and indirect exposures from habitual smoking. Atmos Environ 2003;37:5551–61.
21. Becquemin MH, Bertholon JF, Bentayeb M, et al. Third-hand smoking: indoor measurements of concentration and sizes of cigarette smoke particles after resuspension. Tob Control 2010;19:347–8.
22. Centers for Disease Control and Prevention [Internet]. How can we protect our children from secondhand smoke: a parent’s guide. Accessed 2017 Aug 15 at www.cdc.gov/tobacco/basic_information/secondhand_smoke/protect_children/pdfs/protect_children_guide.pdf.
23. Matt GE, Quintana PJ, Hovell MF, et al. Households contaminated by environmental tobacco smoke: sources of infant exposures. Tob Control 2004;13:29–37.
24. Matt GE, Quintana PJE, Zakarian JM, et al. When smokers move out and non-smokers move in: residential thirdhand smoke pollution and exposure. Tob Control 2011;20:e1.
25. Kraev TA, Adamkiewicz G, Hammond SK, Spengler JD. Indoor concentrations of nicotine in low-income, multi-unit housing: associations with smoking behaviours and housing characteristics. Tob Control 2009;18:438–44.
26. Matt GE, Quintana PJE, Hovell MF, et al. Residual tobacco smoke pollution in used cars for sale: air, dust, and surfaces. Nicotine Tob Res 2008;10:1467–75.
27. Matt GE, Quintana PJE, Fortmann AL, et al. Thirdhand smoke and exposure in California hotels: non-smoking rooms fail to protect non-smoking hotel guests from tobacco smoke exposure. Tob Control 2014;23:264–72.
28. Hang B, Sarker AH, Havel C, et al. Thirdhand smoke causes DNA damage in human cells. Mutagenesis 2013;28:381–91.
29. Mahabee-Gittens EM, Merianos AL, Matt GE. Preliminary evidence that high levels of nicotine on children’s hands may contribute to overall tobacco smoke exposure. Tob Control 2017 Mar 30.
30. Hovell MF, Zakarian JM, Matt GE, et al. Counseling to reduce children’s secondhand smoke exposure and help parents quit smoking: a controlled trial. Nicotine Tob Res 2009;11:1383–94.
31. Northrup TF, Khan AM, Jacob 3rd P, et al. Thirdhand smoke contamination in hospital settings: assessing exposure risk for vulnerable paediatric patients. Tob Control 2016; 25: 619–23.
32. Martins-Green M, Adhami N, Frankos M, et al. Cigarette smoke toxins deposited on surfaces: Implications for human health. PLoS One 2014;9:1–12.
33. Hang B, Snijders AM, Huang Y, et al. Early exposure to thirdhand cigarette smoke affects body mass and the development of immunity in mice. Sci Rep 2017;7:41915.
34. Northrup TF, Matt GE, Hovell MF, et al. Thirdhand smoke in the homes of medically fragile children: Assessing the impact of indoor smoking levels and smoking bans. Nicotine Tob Res 2016;18:1290–8.
35. Marbin JN, Purdy CN, Klaas K, et al. The Clinical Effort against Secondhand Smoke Exposure (CEASE) California: implementing a pediatric clinical intervention to reduce secondhand smoke exposure. Clin Pediatr (Phila) 2016;1(3).
36. Winickoff JP, Hipple B, Drehmer J, et al. The Clinical Effort Against Secondhand Smoke Exposure (CEASE) intervention: A decade of lessons learned. J Clin Outcomes Manag 2012;19:414–9.
37. Farber HJ, Groner J, Walley S, Nelson K. Protecting children from tobacco, nicotine, and tobacco smoke. Pediatrics 2015;136:e1439–67.
38. American Academy of Family Physicians [Internet]. AAFP policies. Tobacco use, prevention, and cessation. Accessed 2017 Aug 29 at www.aafp.org/about/policies/all/tobacco-smoking.html.
39. Farber HJ, Walley SC, Groner JA, et al. Clinical practice policy to protect children from tobacco, nicotine, and tobacco smoke. Pediatrics 2015;136:1008–17.
40. Drehmer J, Hipple B, Murphy S, Winickoff JP. EQIPP: Eliminating tobacco use and exposure to secondhand smoke [online course] PediaLink [Internet]. American Academy of Pediatrics. 2014. Available at bit.ly/eliminate-tobacco-responsive.
41. The American Academy of Pediatrics Julius B. Richmond Center of Excellence [Internet]. Accessed 2017 Aug 9 at www.aap.org/en-us/advocacy-and-policy/aap-health-initiatives/Richmond-Center/Pages/default.aspx.
42. Clinical Effort Against Secondhand Smoke Exposure [Internet]. Accessed at www.massgeneral.org/ceasetobacco/.
43. Winickoff JP, Nabi-Burza E, Chang Y, et al. Implementation of a parental tobacco control intervention in pediatric practice. Pediatrics 2013;132:109–17.
44. Drehmer JE, Ossip DJ, Nabi-Burza E, et al. Thirdhand smoke beliefs of parents. Pediatrics 2014;133:e850–6.
45. Drehmer JE, Ossip DJ, Rigotti NA, et al. Pediatrician interventions and thirdhand smoke beliefs of parents. Am J Prev Med 2012;43:533–6.
46. Samet JM, Chanson D, Wipfli H. The challenges of limiting exposure to THS in vulnerable populations. Curr Environ Health Rep 2015;2:215–25.
47. Thirdhand Smoke Research Consortium [Internet]. Accessed 2017 Aug 15 at www.trdrp.org/highlights-news-events/thirdhand-smoke-consortium.html.
48. Office of the Federal Register (US) [Internet]. Rule instituting smoke-free public housing. 2016. Available at www.federalregister.gov/documents/2016/12/05/2016-28986/instituting-smoke-free-public-housing.
Evaluation of an Enhanced Discharge Summary Template: Building a Better Handoff Document
From the Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE.
Abstract
- Objective: To design and implement an enhanced discharge summary for use by internal medicine providers and evaluate its impact.
- Methods. Pre/post-intervention study in which discharge summaries created in the 3 months before (n = 57) and 3 months after (n = 57) introduction of an enhanced discharge summary template were assessed using a 24-item scoring instrument. Measures evaluated included a composite discharge summary quality score, individual content item scores, global rating score, redundant documentation of consultants and procedures, documentation of non-active conditions, discharge summary word count, and time to completion. Physician satisfaction with the enhanced discharge summary was evaluated by survey.
- Results: The composite discharge summary quality score increased following the intervention (19.07 vs. 13.37, P < 0.001). Ten items showed improved documentation, including documented need for follow-up tests, cognitive status, code status, and communication with the next provider. The global rating score improved from 3.04 to 3.46 (P = 0.01). Discharge summary word count decreased from 717 to 701 (P = 0.002), with no change in the time to discharge summary completion. Surveyed physicians reported improved satisfaction with the enhanced discharge summary compared with the prior template.
- Conclusion: An enhanced discharge summary, designed to serve as a handoff between inpatient and outpatient providers, improved quality without negative effects on document length, time to completion, or physician satisfaction.
Patient safety is often compromised during the transition period following an acute hospitalization. Half of patients may experience an error related to discontinuity of care between inpatient and outpatient providers [1], frequently resulting in preventable adverse events [2,3]. The discharge summary document serves as the primary and often only method of communication between inpatient and outpatient providers [4,5]. Despite its intended purpose, the discharge summary is frequently unavailable at the time of post-discharge clinic visits [4,6,7]. Even when available, the traditional discharge summary may have limited effectiveness as a handoff document due to disorganization or excessive length [8–11].
The Joint Commission requires that a minimum set of elements are documented in every discharge summary, including reason for hospitalization, significant findings, procedures and treatment provided, discharge condition, patient and family instructions, and medication reconciliation [12]. Unfortunately, the required components fail to address many of the complexities encountered in the discharge process and have not adapted to changes in health care delivery. Discharge summary elements related to patients’ future care plans are often inaccurate or omitted [13], including pending diagnostic tests [14–17], recommended outpatient evaluations [18], pertinent discharge condition information [19], and medication changes [1,20,21].
In 2007, the Transitions of Care Consensus Conference made recommendations to address quality gaps in care transitions from inpatient to outpatient settings. This policy statement recommended the adoption of standard discharge summary templates and provided guidance on the addition of specific data elements, including patients’ preferences and goals and clear delineation of care responsibility during the transition period [22]. The use of note templates within the electronic health record (EHR) may help prevent omission of certain data elements [23,24], but inclusion of higher-level management information may require that health providers rethink the function and structure of the discharge summary. Rather than a “captain’s log” narrative of inpatient events, the discharge summary should be considered a handoff document, meant to communicate “a strategic plan for future care. . .lessons learned. . .unresolved issues, and include a projection of how the author believes patients’ clinical condition will evolve over time” [25].
We created and implemented an evidence-based, enhanced discharge summary template to serve as a practical handoff document between inpatient and outpatient providers. This article reports on the evaluation of the enhanced discharge summary in comparison to a traditional discharge summary template.
Methods
Setting
The intervention took place within the inpatient internal medicine service at a 621-bed academic medical center. The internal medicine service includes teaching and non-teaching teams that collectively discharge approximately 4700 patients per year. Approximately 40 staff physicians and 75 residents per year rotate on the inpatient service. The hospital system uses an EHR that supports all clinical activities, including documentation and physician order entry. The EHR also automatically faxes discharge summaries to the primary care physician (PCP) of record when finalized by the inpatient provider. Prior to the intervention, a default discharge summary template was used throughout the hospital system. No formal education on discharge summary composition was provided to inpatient providers or residents prior to this project. This research project was approved by the university institutional review board and was performed without external funding.
Template Redesign
The project was initiated by 2 hospital medicine physicians (CJS and MB) who recruited volunteer representatives from key stakeholder groups to participate in a quality improvement project. The final template redesign team was made up of 4 hospital medicine physicians, 2 ambulatory clinic physicians, 1 internal medicine chief resident, and 1 second-year internal medicine house officer. Two of the physicians (MB and AV) were the departmental EHR champions, serving as the liaisons between providers and EHR technology support/administration. Hospital administration provided analytics and EHR build-support. The team created an enhanced discharge summary template based on recommendations from professional societies [22,26] and published literature [25,27]. We made 4 key changes to the existing discharge summary template.
First, we added a section to the template that listed information crucial to follow-up care needs: tests needed after discharge and provider responsible for follow-up, pending labs at the time of discharge and provider responsible for follow-up, and follow-up appointment information. Provider feedback suggested these elements were frequently omitted or difficult to locate within the body of the discharge summary, so this section was prioritized at the top of the template. To stress the importance of direct communication, we added a heading asking for documentation of contact with the PCP.
Second, in recognition of the increasingly complicated condition of many of our discharging patients, we introduced subheadings and menus that addressed specific elements of patient condition, including cognitive status, indwelling lines and catheters, and activity level at discharge.
Third, a menu-supported section on advance care planning was added that included both code status and an outline of goals-of-care discussions that occurred during the hospitalization.
Finally, we made the template well-organized and succinct. The stand-alone diagnosis list from the pre-intervention template was eliminated and incorporated as part of the problem-based hospital course. In addition, EHR enhancements were introduced to minimize repetition in the lists of consultants, procedures, and chronic medical conditions. We added discrete, prioritized headings with drop down menus and minimized redundancies found in the prior generic template. For example, auto-populated information in the prior default discharge summary included redundant and clinically irrelevant consultants (eg, multiple listings for pharmacy consultation), procedures (eg, recurring hemodialysis encounters), and stable, chronic conditions (eg, hyperlipidemia) that lengthened the discharge summary without adding to its function as a handoff document.
The template was pilot-tested for 2 weeks with teaching and non-teaching teams. A focus group of 5 inpatient providers gave feedback via semi-structured interviews. The research team also solicited unstructured feedback from hospital medicine providers during a required standing administrative meeting. These suggestions informed revisions to the enhanced discharge summary, which was then made the default option for all internal medicine providers.
Education
A 30-minute educational session was developed and delivered by the authors. The objectives of the didactic portion were to describe how discharge summaries can impact patient care, understand how discharge summaries serve as a handoff document, list the components of an effective discharge summary, and describe strategies to avoid common errors in writing discharge summaries. The session included a review of pertinent literature [1,12,13,21], an outline of discharge summary best-practices [22,25], and an introduction to the new template. Trainers reviewed strategies for keeping the discharge summary concise, including using problem-based formatting, focusing on active hospital problems, and eliminating unnecessary or redundant information. Participants were encouraged to complete their discharge summaries and directly contact outpatient providers within 24 hours of discharge. Following the didactic session, participants critically reviewed an example discharge summary and discussed what was done well, what was done poorly, and what strategies they would have used to make it a more effective handoff document. Residents rotating on the inpatient internal medicine services received the education during their mandatory monthly orientation. Faculty physicians were provided the education at a required section meeting.
Quality Scoring of Discharge Summaries and Analysis
To evaluate the quality of discharge summaries, we developed a scoring instrument to measure inclusion of 24 key elements (Table 1). The scoring instrument (available from the authors) was pilot tested by 4 general internal medicine physicians on 5 sample discharge summaries. After independent scoring, this group met with members of the research team to provide feedback. Iterative revisions were made to the scoring instrument until scorers reached consensus in their understanding and application of the scoring instrument. Each discharge summary received a quality score from 0 to 24, based on the number of elements found to be present. Secondary quality metrics included a global quality rating using a 1 to 5 scale (described in Results); frequency of redundant documentation of consultants and procedures; frequency of documentation of non-active, chronic conditions; the length of the discharge summary (total word count); and time to completion.
We analyzed a sample of discharge summaries completed during the 3-month period prior to the intervention and the 3-month period following the intervention. A non-stratified random technique was employed by an independent party to generate discharge summary samples from the EHR. Living patients discharged from the internal medicine services after an inpatient admission of at least 48 hours were eligible for inclusion. Each discharge summary was scored by 2 general internal medicine physicians. Each scoring dyad comprised one of the authors paired with a volunteer non–research team member who scored discharge summaries independently. Discordant results were examined by the dyad and settled by consensus.
Physician Survey
We surveyed inpatient and outpatient physicians to determine their views about discharge summaries and their views about the template before and after the intervention. Respondents were asked to indicate to what degree they agreed with statements using a 5-point Likert scale. An email containing a consent cover letter and a link to an anonymous online survey was sent to residents rotating on internal medicine services during the study period and all hospital medicine faculty. Outpatient providers affiliated with the hospital system were sent the survey if they had received at least 5 discharge summaries from the internal medicine services over the preceding 6 months. Post-intervention surveys were timed to capture responses after an adequate exposure to the enhanced discharge summary template. Inpatient physicians were re-surveyed 3 months after introduction of the enhanced discharge summary and outpatient providers were re-surveyed after 1 year.
Statistical Analysis
We reviewed 10 pre-intervention discharge summaries to estimate baseline discharge summary quality scores. Anticipating a two-fold improvement following the intervention [24], we calculated a goal sample size of 108 discharge summaries (54 pre- and 54 post-intervention) assuming alpha of 0.05 and 80% power using a two-tailed chi-square test. Expecting that some discharge summaries may not meet our inclusion criteria, 114 summaries (57 pre- and 57 post-intervention) were included in the final sample. All analyses were performed on Stata v10.1 (StataCorp; College Station, TX).
For discharge summary quality scoring, inter-rater reliability was measured by calculating the kappa statistic and percent agreement for scoring elements. Chi-square analysis was used to compare individual scoring elements before and after the intervention when the sample size was 5 or greater. Fisher’s exact test was used when the sample size was less than 5. Counts, including number of inactive diagnoses, redundant consults, redundant procedures, and total words were compared using univariate Poisson regression. Wilcoxon rank sum analysis was utilized to compare pre-intervention to post-intervention composite scores and global scores. Patient and provider characteristics were compared using the t-test, chi-square test, Fisher’s exact test, or Wilcoxon rank sum, as appropriate.
For the surveys, pre-intervention and post-intervention matched pairs were compared. Likert score responses were analyzed using the Wilcoxon signed-rank test.
Results
Discharge Summary Quality Scores
Characteristics of the pre- and post-intervention discharge summaries are displayed in Table 2. Both samples were similar with respect to patient demographics, length of stay, medical complexity, and provider characteristics. The mean composite discharge summary quality score improved from 13.4 at baseline to 19.1 in the post-intervention sample (P < 0.001) (Table 3). Ten of 24 quality elements exhibited significant improvement following the intervention, but 3 items were documented less often after the intervention (Table 3).
The global rating of discharge summary quality improved from 3.04 to 3.46 (P = 0.010) (Table 4). Documentation of superfluous and redundant information decreased in the 3 areas evaluated: number of non-active, chronic diagnoses (2.33 to 1.35, P < 0.001), redundant consults (1.4 to 0.09, P < 0.001), and redundant procedures (0.74 to 0.26, P < 0.001). Inter-rater reliability was generally high for individual items, although kappa score was not calculable in one case and scores of zero were obtained for 3 highly concordant items. Inter-rater reliability was moderate for global rating (kappa = 0.59). The overall length of discharge summaries decreased from 717 to 701 words (P = 0.002). There was no significant change in time to discharge summary completion following the intervention (10.9 hours pre-intervention vs. 14.5 post-intervention, P = 0.605) (Table 4).
Survey Results
The inpatient provider response rate for the pre-intervention survey was 51/86 (59%) and 33/65 (51%) for the post-intervention survey, resulting in 21 paired responses. House officers represented the majority of paired respondents (14/21, 66%) with hospitalist faculty making up the remainder. Among outpatient physicians, the pre-intervention response rate was 19/25 (76%) and the post-intervention rate was 20/25 (80%), resulting in 16 paired responses. Half (8/16) of outpatient physicians provided only outpatient care, the other half practicing in a traditional model, providing both inpatient and outpatient care. Nearly half (7/16) had been in practice for over 15 years. Inpatient physicians’ agreement with all 4 statements related to discharge summary quality improved, including their perception of discharge summary effectiveness as a handoff document (P = 0.004). Inpatient providers estimated that the enhanced discharge summary took significantly less time to complete (19.3 vs. 24.6 minutes, P = 0.043). Outpatient providers’ perceptions of discharge summary quality trended toward improvement but did not reach statistical significance (Table 5).
Discussion
We found that a restructured note template in combination with physician education can improve discharge summary quality without sacrificing timeliness of note completion, document length, or physician satisfaction. The Joint Commission requires that discharge summaries include condition at discharge, but global assessments such as “good” or “stable” provide little clinically meaningful information to the next provider. Through our enhanced discharge summary we were able to significantly improve communication of several more specific elements relevant to discharge condition, including cognitive status. Similar to prior studies [7,13], cognitive condition was rarely documented prior to our intervention, but improved to 88% after introduction of the enhanced discharge summary. This is especially important, as we found that 25% of the post-intervention patients had a cognitive deficit at discharge. This information is critical for the next provider, who assumes responsibility for monitoring the patient’s trajectory.
Similarly, we improved the inclusion of patient preferences regarding advanced care planning. Whereas code status was rarely included the pre-intervention discharge summaries, we found that 1 in 5 patients in the post-intervention group did not want cardiopulmonary resuscitation. Beyond code status, we were also able to improve documentation of other advanced care conversations, such as end-of-life planning and power-of-attorney assignment. These conversations are increasingly common in the inpatient setting [28] but inconsistently documented [29,30].
To encourage inpatient-outpatient provider communication, the enhanced discharge summary template prompted documentation of communication with the PCP, with a resultant improvement from 25% to 72% (P < 0.001). The template also increased documentation of contact information for the hospital provider from 4% to 95% (P < 0.001). This improvement is notable, as hospital and outpatient physicians communicate infrequently [4,5], despite the fact that direct, “high-touch” communication is often preferred [10,11].
Our intervention builds upon prior research [23,24,31] through its deliberate focus on template formatting, evaluation of comprehensive clinical data elements using clearly defined scoring criteria, inclusion of teaching and non-teaching inpatient services, and assessment of inpatient and outpatient provider satisfaction. By restructuring the enhanced discharge summary template, we were able to improve documentation of clinical information, patient preferences, and physician communication, while keeping notes concise, prioritized, and timely. This restructuring included re-ordering information within the note, adding clear headings, devising intuitive drop-down menus, and removing unnecessary information. The amount of redundant information, document length, and perceived time required to write the discharge summary improved in the post-intervention period. Finally, our intervention was carried out with few resources and without financial incentives.
Although we found overall improvements following our intervention, there were several notable exceptions. Three content areas that were routinely documented in the pre-intervention period showed significant declines in the post-intervention phase: diet, activity, and procedures. Additionally, despite improvements in the post-intervention group, certain elements continued to be unreliably communicated in the discharge summary. Sporadic inclusion of pending tests (47%) was a particularly concerning finding. One possible explanation is that the addition of new elements and a focus on concise documentation encouraged physicians to skip or delete these areas of the enhanced discharge summary. It is also possible that reliance on drop-down menus and manual text entry, rather than auto-populated data, contributed to these deficits. As organizations re-design their electronic note templates, they should consider different content importing options [32] based on local institutional needs, culture, and EHR capabilities [33].
This study had several limitations. It was conducted at a single academic institution, so findings may not be generalizable to other settings. Although the magnitude and specificity of many of the measured outcomes suggests they were caused by the intervention, our pre/post study design cannot rule out the possibility that time-varying factors other than the intervention may have influenced our findings. We also used a novel scoring instrument, as a psychometrically tested discharge summary scoring instrument was not available at the time of the study [34]. Because it was based on similar concepts and evidence, the scoring instrument mirrored the data elements included in the intervention, which may have biased our results away from the null. However, the global rating score, which provided an overall appraisal of discharge summary quality unrelated to specific elements of the intervention, also showed significant improvement following the intervention. The distinct formatting of pre- and post-intervention templates meant that scorers were not blinded, thus making social desirability bias a possibility. We attempted to minimize the risk for bias by having all discharge summaries scored by 2 scorers, including one physician who was not a member of the research team. Small sample sizes, particularly with regard to the outpatient survey, may have contributed to type II errors. Additionally, although the discharge summary education was delivered during required meetings, we did not track attendance, so we were unable analyze for differences between providers who received the education and those that did not. Finally, while we evaluated discharge summaries for inclusion of key information, we did not perform chart reviews or contact PCPs to confirm the accuracy of documented information. Future study should evaluate the sustainability of our intervention and its impact on patient-level outcomes.
In conclusion, we found that revising our electronic template to better function as a handoff document could improve discharge summary quality. While most content areas evaluated showed improvement, there were several elements that were negatively impacted. Hospitals should be deliberate when reformatting their discharge summary templates so as to balance the need for efficient, manageable template navigation with accurate, complete, and necessary information.
Corresponding author: Christopher J. Smith, MD, 986430 Nebraska Medical Center Omaha, NE 68198-6430 Email: csmithj@unmc.edu.
Financial disclosures: None.
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From the Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE.
Abstract
- Objective: To design and implement an enhanced discharge summary for use by internal medicine providers and evaluate its impact.
- Methods. Pre/post-intervention study in which discharge summaries created in the 3 months before (n = 57) and 3 months after (n = 57) introduction of an enhanced discharge summary template were assessed using a 24-item scoring instrument. Measures evaluated included a composite discharge summary quality score, individual content item scores, global rating score, redundant documentation of consultants and procedures, documentation of non-active conditions, discharge summary word count, and time to completion. Physician satisfaction with the enhanced discharge summary was evaluated by survey.
- Results: The composite discharge summary quality score increased following the intervention (19.07 vs. 13.37, P < 0.001). Ten items showed improved documentation, including documented need for follow-up tests, cognitive status, code status, and communication with the next provider. The global rating score improved from 3.04 to 3.46 (P = 0.01). Discharge summary word count decreased from 717 to 701 (P = 0.002), with no change in the time to discharge summary completion. Surveyed physicians reported improved satisfaction with the enhanced discharge summary compared with the prior template.
- Conclusion: An enhanced discharge summary, designed to serve as a handoff between inpatient and outpatient providers, improved quality without negative effects on document length, time to completion, or physician satisfaction.
Patient safety is often compromised during the transition period following an acute hospitalization. Half of patients may experience an error related to discontinuity of care between inpatient and outpatient providers [1], frequently resulting in preventable adverse events [2,3]. The discharge summary document serves as the primary and often only method of communication between inpatient and outpatient providers [4,5]. Despite its intended purpose, the discharge summary is frequently unavailable at the time of post-discharge clinic visits [4,6,7]. Even when available, the traditional discharge summary may have limited effectiveness as a handoff document due to disorganization or excessive length [8–11].
The Joint Commission requires that a minimum set of elements are documented in every discharge summary, including reason for hospitalization, significant findings, procedures and treatment provided, discharge condition, patient and family instructions, and medication reconciliation [12]. Unfortunately, the required components fail to address many of the complexities encountered in the discharge process and have not adapted to changes in health care delivery. Discharge summary elements related to patients’ future care plans are often inaccurate or omitted [13], including pending diagnostic tests [14–17], recommended outpatient evaluations [18], pertinent discharge condition information [19], and medication changes [1,20,21].
In 2007, the Transitions of Care Consensus Conference made recommendations to address quality gaps in care transitions from inpatient to outpatient settings. This policy statement recommended the adoption of standard discharge summary templates and provided guidance on the addition of specific data elements, including patients’ preferences and goals and clear delineation of care responsibility during the transition period [22]. The use of note templates within the electronic health record (EHR) may help prevent omission of certain data elements [23,24], but inclusion of higher-level management information may require that health providers rethink the function and structure of the discharge summary. Rather than a “captain’s log” narrative of inpatient events, the discharge summary should be considered a handoff document, meant to communicate “a strategic plan for future care. . .lessons learned. . .unresolved issues, and include a projection of how the author believes patients’ clinical condition will evolve over time” [25].
We created and implemented an evidence-based, enhanced discharge summary template to serve as a practical handoff document between inpatient and outpatient providers. This article reports on the evaluation of the enhanced discharge summary in comparison to a traditional discharge summary template.
Methods
Setting
The intervention took place within the inpatient internal medicine service at a 621-bed academic medical center. The internal medicine service includes teaching and non-teaching teams that collectively discharge approximately 4700 patients per year. Approximately 40 staff physicians and 75 residents per year rotate on the inpatient service. The hospital system uses an EHR that supports all clinical activities, including documentation and physician order entry. The EHR also automatically faxes discharge summaries to the primary care physician (PCP) of record when finalized by the inpatient provider. Prior to the intervention, a default discharge summary template was used throughout the hospital system. No formal education on discharge summary composition was provided to inpatient providers or residents prior to this project. This research project was approved by the university institutional review board and was performed without external funding.
Template Redesign
The project was initiated by 2 hospital medicine physicians (CJS and MB) who recruited volunteer representatives from key stakeholder groups to participate in a quality improvement project. The final template redesign team was made up of 4 hospital medicine physicians, 2 ambulatory clinic physicians, 1 internal medicine chief resident, and 1 second-year internal medicine house officer. Two of the physicians (MB and AV) were the departmental EHR champions, serving as the liaisons between providers and EHR technology support/administration. Hospital administration provided analytics and EHR build-support. The team created an enhanced discharge summary template based on recommendations from professional societies [22,26] and published literature [25,27]. We made 4 key changes to the existing discharge summary template.
First, we added a section to the template that listed information crucial to follow-up care needs: tests needed after discharge and provider responsible for follow-up, pending labs at the time of discharge and provider responsible for follow-up, and follow-up appointment information. Provider feedback suggested these elements were frequently omitted or difficult to locate within the body of the discharge summary, so this section was prioritized at the top of the template. To stress the importance of direct communication, we added a heading asking for documentation of contact with the PCP.
Second, in recognition of the increasingly complicated condition of many of our discharging patients, we introduced subheadings and menus that addressed specific elements of patient condition, including cognitive status, indwelling lines and catheters, and activity level at discharge.
Third, a menu-supported section on advance care planning was added that included both code status and an outline of goals-of-care discussions that occurred during the hospitalization.
Finally, we made the template well-organized and succinct. The stand-alone diagnosis list from the pre-intervention template was eliminated and incorporated as part of the problem-based hospital course. In addition, EHR enhancements were introduced to minimize repetition in the lists of consultants, procedures, and chronic medical conditions. We added discrete, prioritized headings with drop down menus and minimized redundancies found in the prior generic template. For example, auto-populated information in the prior default discharge summary included redundant and clinically irrelevant consultants (eg, multiple listings for pharmacy consultation), procedures (eg, recurring hemodialysis encounters), and stable, chronic conditions (eg, hyperlipidemia) that lengthened the discharge summary without adding to its function as a handoff document.
The template was pilot-tested for 2 weeks with teaching and non-teaching teams. A focus group of 5 inpatient providers gave feedback via semi-structured interviews. The research team also solicited unstructured feedback from hospital medicine providers during a required standing administrative meeting. These suggestions informed revisions to the enhanced discharge summary, which was then made the default option for all internal medicine providers.
Education
A 30-minute educational session was developed and delivered by the authors. The objectives of the didactic portion were to describe how discharge summaries can impact patient care, understand how discharge summaries serve as a handoff document, list the components of an effective discharge summary, and describe strategies to avoid common errors in writing discharge summaries. The session included a review of pertinent literature [1,12,13,21], an outline of discharge summary best-practices [22,25], and an introduction to the new template. Trainers reviewed strategies for keeping the discharge summary concise, including using problem-based formatting, focusing on active hospital problems, and eliminating unnecessary or redundant information. Participants were encouraged to complete their discharge summaries and directly contact outpatient providers within 24 hours of discharge. Following the didactic session, participants critically reviewed an example discharge summary and discussed what was done well, what was done poorly, and what strategies they would have used to make it a more effective handoff document. Residents rotating on the inpatient internal medicine services received the education during their mandatory monthly orientation. Faculty physicians were provided the education at a required section meeting.
Quality Scoring of Discharge Summaries and Analysis
To evaluate the quality of discharge summaries, we developed a scoring instrument to measure inclusion of 24 key elements (Table 1). The scoring instrument (available from the authors) was pilot tested by 4 general internal medicine physicians on 5 sample discharge summaries. After independent scoring, this group met with members of the research team to provide feedback. Iterative revisions were made to the scoring instrument until scorers reached consensus in their understanding and application of the scoring instrument. Each discharge summary received a quality score from 0 to 24, based on the number of elements found to be present. Secondary quality metrics included a global quality rating using a 1 to 5 scale (described in Results); frequency of redundant documentation of consultants and procedures; frequency of documentation of non-active, chronic conditions; the length of the discharge summary (total word count); and time to completion.
We analyzed a sample of discharge summaries completed during the 3-month period prior to the intervention and the 3-month period following the intervention. A non-stratified random technique was employed by an independent party to generate discharge summary samples from the EHR. Living patients discharged from the internal medicine services after an inpatient admission of at least 48 hours were eligible for inclusion. Each discharge summary was scored by 2 general internal medicine physicians. Each scoring dyad comprised one of the authors paired with a volunteer non–research team member who scored discharge summaries independently. Discordant results were examined by the dyad and settled by consensus.
Physician Survey
We surveyed inpatient and outpatient physicians to determine their views about discharge summaries and their views about the template before and after the intervention. Respondents were asked to indicate to what degree they agreed with statements using a 5-point Likert scale. An email containing a consent cover letter and a link to an anonymous online survey was sent to residents rotating on internal medicine services during the study period and all hospital medicine faculty. Outpatient providers affiliated with the hospital system were sent the survey if they had received at least 5 discharge summaries from the internal medicine services over the preceding 6 months. Post-intervention surveys were timed to capture responses after an adequate exposure to the enhanced discharge summary template. Inpatient physicians were re-surveyed 3 months after introduction of the enhanced discharge summary and outpatient providers were re-surveyed after 1 year.
Statistical Analysis
We reviewed 10 pre-intervention discharge summaries to estimate baseline discharge summary quality scores. Anticipating a two-fold improvement following the intervention [24], we calculated a goal sample size of 108 discharge summaries (54 pre- and 54 post-intervention) assuming alpha of 0.05 and 80% power using a two-tailed chi-square test. Expecting that some discharge summaries may not meet our inclusion criteria, 114 summaries (57 pre- and 57 post-intervention) were included in the final sample. All analyses were performed on Stata v10.1 (StataCorp; College Station, TX).
For discharge summary quality scoring, inter-rater reliability was measured by calculating the kappa statistic and percent agreement for scoring elements. Chi-square analysis was used to compare individual scoring elements before and after the intervention when the sample size was 5 or greater. Fisher’s exact test was used when the sample size was less than 5. Counts, including number of inactive diagnoses, redundant consults, redundant procedures, and total words were compared using univariate Poisson regression. Wilcoxon rank sum analysis was utilized to compare pre-intervention to post-intervention composite scores and global scores. Patient and provider characteristics were compared using the t-test, chi-square test, Fisher’s exact test, or Wilcoxon rank sum, as appropriate.
For the surveys, pre-intervention and post-intervention matched pairs were compared. Likert score responses were analyzed using the Wilcoxon signed-rank test.
Results
Discharge Summary Quality Scores
Characteristics of the pre- and post-intervention discharge summaries are displayed in Table 2. Both samples were similar with respect to patient demographics, length of stay, medical complexity, and provider characteristics. The mean composite discharge summary quality score improved from 13.4 at baseline to 19.1 in the post-intervention sample (P < 0.001) (Table 3). Ten of 24 quality elements exhibited significant improvement following the intervention, but 3 items were documented less often after the intervention (Table 3).
The global rating of discharge summary quality improved from 3.04 to 3.46 (P = 0.010) (Table 4). Documentation of superfluous and redundant information decreased in the 3 areas evaluated: number of non-active, chronic diagnoses (2.33 to 1.35, P < 0.001), redundant consults (1.4 to 0.09, P < 0.001), and redundant procedures (0.74 to 0.26, P < 0.001). Inter-rater reliability was generally high for individual items, although kappa score was not calculable in one case and scores of zero were obtained for 3 highly concordant items. Inter-rater reliability was moderate for global rating (kappa = 0.59). The overall length of discharge summaries decreased from 717 to 701 words (P = 0.002). There was no significant change in time to discharge summary completion following the intervention (10.9 hours pre-intervention vs. 14.5 post-intervention, P = 0.605) (Table 4).
Survey Results
The inpatient provider response rate for the pre-intervention survey was 51/86 (59%) and 33/65 (51%) for the post-intervention survey, resulting in 21 paired responses. House officers represented the majority of paired respondents (14/21, 66%) with hospitalist faculty making up the remainder. Among outpatient physicians, the pre-intervention response rate was 19/25 (76%) and the post-intervention rate was 20/25 (80%), resulting in 16 paired responses. Half (8/16) of outpatient physicians provided only outpatient care, the other half practicing in a traditional model, providing both inpatient and outpatient care. Nearly half (7/16) had been in practice for over 15 years. Inpatient physicians’ agreement with all 4 statements related to discharge summary quality improved, including their perception of discharge summary effectiveness as a handoff document (P = 0.004). Inpatient providers estimated that the enhanced discharge summary took significantly less time to complete (19.3 vs. 24.6 minutes, P = 0.043). Outpatient providers’ perceptions of discharge summary quality trended toward improvement but did not reach statistical significance (Table 5).
Discussion
We found that a restructured note template in combination with physician education can improve discharge summary quality without sacrificing timeliness of note completion, document length, or physician satisfaction. The Joint Commission requires that discharge summaries include condition at discharge, but global assessments such as “good” or “stable” provide little clinically meaningful information to the next provider. Through our enhanced discharge summary we were able to significantly improve communication of several more specific elements relevant to discharge condition, including cognitive status. Similar to prior studies [7,13], cognitive condition was rarely documented prior to our intervention, but improved to 88% after introduction of the enhanced discharge summary. This is especially important, as we found that 25% of the post-intervention patients had a cognitive deficit at discharge. This information is critical for the next provider, who assumes responsibility for monitoring the patient’s trajectory.
Similarly, we improved the inclusion of patient preferences regarding advanced care planning. Whereas code status was rarely included the pre-intervention discharge summaries, we found that 1 in 5 patients in the post-intervention group did not want cardiopulmonary resuscitation. Beyond code status, we were also able to improve documentation of other advanced care conversations, such as end-of-life planning and power-of-attorney assignment. These conversations are increasingly common in the inpatient setting [28] but inconsistently documented [29,30].
To encourage inpatient-outpatient provider communication, the enhanced discharge summary template prompted documentation of communication with the PCP, with a resultant improvement from 25% to 72% (P < 0.001). The template also increased documentation of contact information for the hospital provider from 4% to 95% (P < 0.001). This improvement is notable, as hospital and outpatient physicians communicate infrequently [4,5], despite the fact that direct, “high-touch” communication is often preferred [10,11].
Our intervention builds upon prior research [23,24,31] through its deliberate focus on template formatting, evaluation of comprehensive clinical data elements using clearly defined scoring criteria, inclusion of teaching and non-teaching inpatient services, and assessment of inpatient and outpatient provider satisfaction. By restructuring the enhanced discharge summary template, we were able to improve documentation of clinical information, patient preferences, and physician communication, while keeping notes concise, prioritized, and timely. This restructuring included re-ordering information within the note, adding clear headings, devising intuitive drop-down menus, and removing unnecessary information. The amount of redundant information, document length, and perceived time required to write the discharge summary improved in the post-intervention period. Finally, our intervention was carried out with few resources and without financial incentives.
Although we found overall improvements following our intervention, there were several notable exceptions. Three content areas that were routinely documented in the pre-intervention period showed significant declines in the post-intervention phase: diet, activity, and procedures. Additionally, despite improvements in the post-intervention group, certain elements continued to be unreliably communicated in the discharge summary. Sporadic inclusion of pending tests (47%) was a particularly concerning finding. One possible explanation is that the addition of new elements and a focus on concise documentation encouraged physicians to skip or delete these areas of the enhanced discharge summary. It is also possible that reliance on drop-down menus and manual text entry, rather than auto-populated data, contributed to these deficits. As organizations re-design their electronic note templates, they should consider different content importing options [32] based on local institutional needs, culture, and EHR capabilities [33].
This study had several limitations. It was conducted at a single academic institution, so findings may not be generalizable to other settings. Although the magnitude and specificity of many of the measured outcomes suggests they were caused by the intervention, our pre/post study design cannot rule out the possibility that time-varying factors other than the intervention may have influenced our findings. We also used a novel scoring instrument, as a psychometrically tested discharge summary scoring instrument was not available at the time of the study [34]. Because it was based on similar concepts and evidence, the scoring instrument mirrored the data elements included in the intervention, which may have biased our results away from the null. However, the global rating score, which provided an overall appraisal of discharge summary quality unrelated to specific elements of the intervention, also showed significant improvement following the intervention. The distinct formatting of pre- and post-intervention templates meant that scorers were not blinded, thus making social desirability bias a possibility. We attempted to minimize the risk for bias by having all discharge summaries scored by 2 scorers, including one physician who was not a member of the research team. Small sample sizes, particularly with regard to the outpatient survey, may have contributed to type II errors. Additionally, although the discharge summary education was delivered during required meetings, we did not track attendance, so we were unable analyze for differences between providers who received the education and those that did not. Finally, while we evaluated discharge summaries for inclusion of key information, we did not perform chart reviews or contact PCPs to confirm the accuracy of documented information. Future study should evaluate the sustainability of our intervention and its impact on patient-level outcomes.
In conclusion, we found that revising our electronic template to better function as a handoff document could improve discharge summary quality. While most content areas evaluated showed improvement, there were several elements that were negatively impacted. Hospitals should be deliberate when reformatting their discharge summary templates so as to balance the need for efficient, manageable template navigation with accurate, complete, and necessary information.
Corresponding author: Christopher J. Smith, MD, 986430 Nebraska Medical Center Omaha, NE 68198-6430 Email: csmithj@unmc.edu.
Financial disclosures: None.
From the Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE.
Abstract
- Objective: To design and implement an enhanced discharge summary for use by internal medicine providers and evaluate its impact.
- Methods. Pre/post-intervention study in which discharge summaries created in the 3 months before (n = 57) and 3 months after (n = 57) introduction of an enhanced discharge summary template were assessed using a 24-item scoring instrument. Measures evaluated included a composite discharge summary quality score, individual content item scores, global rating score, redundant documentation of consultants and procedures, documentation of non-active conditions, discharge summary word count, and time to completion. Physician satisfaction with the enhanced discharge summary was evaluated by survey.
- Results: The composite discharge summary quality score increased following the intervention (19.07 vs. 13.37, P < 0.001). Ten items showed improved documentation, including documented need for follow-up tests, cognitive status, code status, and communication with the next provider. The global rating score improved from 3.04 to 3.46 (P = 0.01). Discharge summary word count decreased from 717 to 701 (P = 0.002), with no change in the time to discharge summary completion. Surveyed physicians reported improved satisfaction with the enhanced discharge summary compared with the prior template.
- Conclusion: An enhanced discharge summary, designed to serve as a handoff between inpatient and outpatient providers, improved quality without negative effects on document length, time to completion, or physician satisfaction.
Patient safety is often compromised during the transition period following an acute hospitalization. Half of patients may experience an error related to discontinuity of care between inpatient and outpatient providers [1], frequently resulting in preventable adverse events [2,3]. The discharge summary document serves as the primary and often only method of communication between inpatient and outpatient providers [4,5]. Despite its intended purpose, the discharge summary is frequently unavailable at the time of post-discharge clinic visits [4,6,7]. Even when available, the traditional discharge summary may have limited effectiveness as a handoff document due to disorganization or excessive length [8–11].
The Joint Commission requires that a minimum set of elements are documented in every discharge summary, including reason for hospitalization, significant findings, procedures and treatment provided, discharge condition, patient and family instructions, and medication reconciliation [12]. Unfortunately, the required components fail to address many of the complexities encountered in the discharge process and have not adapted to changes in health care delivery. Discharge summary elements related to patients’ future care plans are often inaccurate or omitted [13], including pending diagnostic tests [14–17], recommended outpatient evaluations [18], pertinent discharge condition information [19], and medication changes [1,20,21].
In 2007, the Transitions of Care Consensus Conference made recommendations to address quality gaps in care transitions from inpatient to outpatient settings. This policy statement recommended the adoption of standard discharge summary templates and provided guidance on the addition of specific data elements, including patients’ preferences and goals and clear delineation of care responsibility during the transition period [22]. The use of note templates within the electronic health record (EHR) may help prevent omission of certain data elements [23,24], but inclusion of higher-level management information may require that health providers rethink the function and structure of the discharge summary. Rather than a “captain’s log” narrative of inpatient events, the discharge summary should be considered a handoff document, meant to communicate “a strategic plan for future care. . .lessons learned. . .unresolved issues, and include a projection of how the author believes patients’ clinical condition will evolve over time” [25].
We created and implemented an evidence-based, enhanced discharge summary template to serve as a practical handoff document between inpatient and outpatient providers. This article reports on the evaluation of the enhanced discharge summary in comparison to a traditional discharge summary template.
Methods
Setting
The intervention took place within the inpatient internal medicine service at a 621-bed academic medical center. The internal medicine service includes teaching and non-teaching teams that collectively discharge approximately 4700 patients per year. Approximately 40 staff physicians and 75 residents per year rotate on the inpatient service. The hospital system uses an EHR that supports all clinical activities, including documentation and physician order entry. The EHR also automatically faxes discharge summaries to the primary care physician (PCP) of record when finalized by the inpatient provider. Prior to the intervention, a default discharge summary template was used throughout the hospital system. No formal education on discharge summary composition was provided to inpatient providers or residents prior to this project. This research project was approved by the university institutional review board and was performed without external funding.
Template Redesign
The project was initiated by 2 hospital medicine physicians (CJS and MB) who recruited volunteer representatives from key stakeholder groups to participate in a quality improvement project. The final template redesign team was made up of 4 hospital medicine physicians, 2 ambulatory clinic physicians, 1 internal medicine chief resident, and 1 second-year internal medicine house officer. Two of the physicians (MB and AV) were the departmental EHR champions, serving as the liaisons between providers and EHR technology support/administration. Hospital administration provided analytics and EHR build-support. The team created an enhanced discharge summary template based on recommendations from professional societies [22,26] and published literature [25,27]. We made 4 key changes to the existing discharge summary template.
First, we added a section to the template that listed information crucial to follow-up care needs: tests needed after discharge and provider responsible for follow-up, pending labs at the time of discharge and provider responsible for follow-up, and follow-up appointment information. Provider feedback suggested these elements were frequently omitted or difficult to locate within the body of the discharge summary, so this section was prioritized at the top of the template. To stress the importance of direct communication, we added a heading asking for documentation of contact with the PCP.
Second, in recognition of the increasingly complicated condition of many of our discharging patients, we introduced subheadings and menus that addressed specific elements of patient condition, including cognitive status, indwelling lines and catheters, and activity level at discharge.
Third, a menu-supported section on advance care planning was added that included both code status and an outline of goals-of-care discussions that occurred during the hospitalization.
Finally, we made the template well-organized and succinct. The stand-alone diagnosis list from the pre-intervention template was eliminated and incorporated as part of the problem-based hospital course. In addition, EHR enhancements were introduced to minimize repetition in the lists of consultants, procedures, and chronic medical conditions. We added discrete, prioritized headings with drop down menus and minimized redundancies found in the prior generic template. For example, auto-populated information in the prior default discharge summary included redundant and clinically irrelevant consultants (eg, multiple listings for pharmacy consultation), procedures (eg, recurring hemodialysis encounters), and stable, chronic conditions (eg, hyperlipidemia) that lengthened the discharge summary without adding to its function as a handoff document.
The template was pilot-tested for 2 weeks with teaching and non-teaching teams. A focus group of 5 inpatient providers gave feedback via semi-structured interviews. The research team also solicited unstructured feedback from hospital medicine providers during a required standing administrative meeting. These suggestions informed revisions to the enhanced discharge summary, which was then made the default option for all internal medicine providers.
Education
A 30-minute educational session was developed and delivered by the authors. The objectives of the didactic portion were to describe how discharge summaries can impact patient care, understand how discharge summaries serve as a handoff document, list the components of an effective discharge summary, and describe strategies to avoid common errors in writing discharge summaries. The session included a review of pertinent literature [1,12,13,21], an outline of discharge summary best-practices [22,25], and an introduction to the new template. Trainers reviewed strategies for keeping the discharge summary concise, including using problem-based formatting, focusing on active hospital problems, and eliminating unnecessary or redundant information. Participants were encouraged to complete their discharge summaries and directly contact outpatient providers within 24 hours of discharge. Following the didactic session, participants critically reviewed an example discharge summary and discussed what was done well, what was done poorly, and what strategies they would have used to make it a more effective handoff document. Residents rotating on the inpatient internal medicine services received the education during their mandatory monthly orientation. Faculty physicians were provided the education at a required section meeting.
Quality Scoring of Discharge Summaries and Analysis
To evaluate the quality of discharge summaries, we developed a scoring instrument to measure inclusion of 24 key elements (Table 1). The scoring instrument (available from the authors) was pilot tested by 4 general internal medicine physicians on 5 sample discharge summaries. After independent scoring, this group met with members of the research team to provide feedback. Iterative revisions were made to the scoring instrument until scorers reached consensus in their understanding and application of the scoring instrument. Each discharge summary received a quality score from 0 to 24, based on the number of elements found to be present. Secondary quality metrics included a global quality rating using a 1 to 5 scale (described in Results); frequency of redundant documentation of consultants and procedures; frequency of documentation of non-active, chronic conditions; the length of the discharge summary (total word count); and time to completion.
We analyzed a sample of discharge summaries completed during the 3-month period prior to the intervention and the 3-month period following the intervention. A non-stratified random technique was employed by an independent party to generate discharge summary samples from the EHR. Living patients discharged from the internal medicine services after an inpatient admission of at least 48 hours were eligible for inclusion. Each discharge summary was scored by 2 general internal medicine physicians. Each scoring dyad comprised one of the authors paired with a volunteer non–research team member who scored discharge summaries independently. Discordant results were examined by the dyad and settled by consensus.
Physician Survey
We surveyed inpatient and outpatient physicians to determine their views about discharge summaries and their views about the template before and after the intervention. Respondents were asked to indicate to what degree they agreed with statements using a 5-point Likert scale. An email containing a consent cover letter and a link to an anonymous online survey was sent to residents rotating on internal medicine services during the study period and all hospital medicine faculty. Outpatient providers affiliated with the hospital system were sent the survey if they had received at least 5 discharge summaries from the internal medicine services over the preceding 6 months. Post-intervention surveys were timed to capture responses after an adequate exposure to the enhanced discharge summary template. Inpatient physicians were re-surveyed 3 months after introduction of the enhanced discharge summary and outpatient providers were re-surveyed after 1 year.
Statistical Analysis
We reviewed 10 pre-intervention discharge summaries to estimate baseline discharge summary quality scores. Anticipating a two-fold improvement following the intervention [24], we calculated a goal sample size of 108 discharge summaries (54 pre- and 54 post-intervention) assuming alpha of 0.05 and 80% power using a two-tailed chi-square test. Expecting that some discharge summaries may not meet our inclusion criteria, 114 summaries (57 pre- and 57 post-intervention) were included in the final sample. All analyses were performed on Stata v10.1 (StataCorp; College Station, TX).
For discharge summary quality scoring, inter-rater reliability was measured by calculating the kappa statistic and percent agreement for scoring elements. Chi-square analysis was used to compare individual scoring elements before and after the intervention when the sample size was 5 or greater. Fisher’s exact test was used when the sample size was less than 5. Counts, including number of inactive diagnoses, redundant consults, redundant procedures, and total words were compared using univariate Poisson regression. Wilcoxon rank sum analysis was utilized to compare pre-intervention to post-intervention composite scores and global scores. Patient and provider characteristics were compared using the t-test, chi-square test, Fisher’s exact test, or Wilcoxon rank sum, as appropriate.
For the surveys, pre-intervention and post-intervention matched pairs were compared. Likert score responses were analyzed using the Wilcoxon signed-rank test.
Results
Discharge Summary Quality Scores
Characteristics of the pre- and post-intervention discharge summaries are displayed in Table 2. Both samples were similar with respect to patient demographics, length of stay, medical complexity, and provider characteristics. The mean composite discharge summary quality score improved from 13.4 at baseline to 19.1 in the post-intervention sample (P < 0.001) (Table 3). Ten of 24 quality elements exhibited significant improvement following the intervention, but 3 items were documented less often after the intervention (Table 3).
The global rating of discharge summary quality improved from 3.04 to 3.46 (P = 0.010) (Table 4). Documentation of superfluous and redundant information decreased in the 3 areas evaluated: number of non-active, chronic diagnoses (2.33 to 1.35, P < 0.001), redundant consults (1.4 to 0.09, P < 0.001), and redundant procedures (0.74 to 0.26, P < 0.001). Inter-rater reliability was generally high for individual items, although kappa score was not calculable in one case and scores of zero were obtained for 3 highly concordant items. Inter-rater reliability was moderate for global rating (kappa = 0.59). The overall length of discharge summaries decreased from 717 to 701 words (P = 0.002). There was no significant change in time to discharge summary completion following the intervention (10.9 hours pre-intervention vs. 14.5 post-intervention, P = 0.605) (Table 4).
Survey Results
The inpatient provider response rate for the pre-intervention survey was 51/86 (59%) and 33/65 (51%) for the post-intervention survey, resulting in 21 paired responses. House officers represented the majority of paired respondents (14/21, 66%) with hospitalist faculty making up the remainder. Among outpatient physicians, the pre-intervention response rate was 19/25 (76%) and the post-intervention rate was 20/25 (80%), resulting in 16 paired responses. Half (8/16) of outpatient physicians provided only outpatient care, the other half practicing in a traditional model, providing both inpatient and outpatient care. Nearly half (7/16) had been in practice for over 15 years. Inpatient physicians’ agreement with all 4 statements related to discharge summary quality improved, including their perception of discharge summary effectiveness as a handoff document (P = 0.004). Inpatient providers estimated that the enhanced discharge summary took significantly less time to complete (19.3 vs. 24.6 minutes, P = 0.043). Outpatient providers’ perceptions of discharge summary quality trended toward improvement but did not reach statistical significance (Table 5).
Discussion
We found that a restructured note template in combination with physician education can improve discharge summary quality without sacrificing timeliness of note completion, document length, or physician satisfaction. The Joint Commission requires that discharge summaries include condition at discharge, but global assessments such as “good” or “stable” provide little clinically meaningful information to the next provider. Through our enhanced discharge summary we were able to significantly improve communication of several more specific elements relevant to discharge condition, including cognitive status. Similar to prior studies [7,13], cognitive condition was rarely documented prior to our intervention, but improved to 88% after introduction of the enhanced discharge summary. This is especially important, as we found that 25% of the post-intervention patients had a cognitive deficit at discharge. This information is critical for the next provider, who assumes responsibility for monitoring the patient’s trajectory.
Similarly, we improved the inclusion of patient preferences regarding advanced care planning. Whereas code status was rarely included the pre-intervention discharge summaries, we found that 1 in 5 patients in the post-intervention group did not want cardiopulmonary resuscitation. Beyond code status, we were also able to improve documentation of other advanced care conversations, such as end-of-life planning and power-of-attorney assignment. These conversations are increasingly common in the inpatient setting [28] but inconsistently documented [29,30].
To encourage inpatient-outpatient provider communication, the enhanced discharge summary template prompted documentation of communication with the PCP, with a resultant improvement from 25% to 72% (P < 0.001). The template also increased documentation of contact information for the hospital provider from 4% to 95% (P < 0.001). This improvement is notable, as hospital and outpatient physicians communicate infrequently [4,5], despite the fact that direct, “high-touch” communication is often preferred [10,11].
Our intervention builds upon prior research [23,24,31] through its deliberate focus on template formatting, evaluation of comprehensive clinical data elements using clearly defined scoring criteria, inclusion of teaching and non-teaching inpatient services, and assessment of inpatient and outpatient provider satisfaction. By restructuring the enhanced discharge summary template, we were able to improve documentation of clinical information, patient preferences, and physician communication, while keeping notes concise, prioritized, and timely. This restructuring included re-ordering information within the note, adding clear headings, devising intuitive drop-down menus, and removing unnecessary information. The amount of redundant information, document length, and perceived time required to write the discharge summary improved in the post-intervention period. Finally, our intervention was carried out with few resources and without financial incentives.
Although we found overall improvements following our intervention, there were several notable exceptions. Three content areas that were routinely documented in the pre-intervention period showed significant declines in the post-intervention phase: diet, activity, and procedures. Additionally, despite improvements in the post-intervention group, certain elements continued to be unreliably communicated in the discharge summary. Sporadic inclusion of pending tests (47%) was a particularly concerning finding. One possible explanation is that the addition of new elements and a focus on concise documentation encouraged physicians to skip or delete these areas of the enhanced discharge summary. It is also possible that reliance on drop-down menus and manual text entry, rather than auto-populated data, contributed to these deficits. As organizations re-design their electronic note templates, they should consider different content importing options [32] based on local institutional needs, culture, and EHR capabilities [33].
This study had several limitations. It was conducted at a single academic institution, so findings may not be generalizable to other settings. Although the magnitude and specificity of many of the measured outcomes suggests they were caused by the intervention, our pre/post study design cannot rule out the possibility that time-varying factors other than the intervention may have influenced our findings. We also used a novel scoring instrument, as a psychometrically tested discharge summary scoring instrument was not available at the time of the study [34]. Because it was based on similar concepts and evidence, the scoring instrument mirrored the data elements included in the intervention, which may have biased our results away from the null. However, the global rating score, which provided an overall appraisal of discharge summary quality unrelated to specific elements of the intervention, also showed significant improvement following the intervention. The distinct formatting of pre- and post-intervention templates meant that scorers were not blinded, thus making social desirability bias a possibility. We attempted to minimize the risk for bias by having all discharge summaries scored by 2 scorers, including one physician who was not a member of the research team. Small sample sizes, particularly with regard to the outpatient survey, may have contributed to type II errors. Additionally, although the discharge summary education was delivered during required meetings, we did not track attendance, so we were unable analyze for differences between providers who received the education and those that did not. Finally, while we evaluated discharge summaries for inclusion of key information, we did not perform chart reviews or contact PCPs to confirm the accuracy of documented information. Future study should evaluate the sustainability of our intervention and its impact on patient-level outcomes.
In conclusion, we found that revising our electronic template to better function as a handoff document could improve discharge summary quality. While most content areas evaluated showed improvement, there were several elements that were negatively impacted. Hospitals should be deliberate when reformatting their discharge summary templates so as to balance the need for efficient, manageable template navigation with accurate, complete, and necessary information.
Corresponding author: Christopher J. Smith, MD, 986430 Nebraska Medical Center Omaha, NE 68198-6430 Email: csmithj@unmc.edu.
Financial disclosures: None.
1. Moore C, Wisnivesky J, Williams S, McGinn T. Medical errors related to discontinuity of care from an inpatient to an outpatient setting. J Gen Intern Med 2003;18:646–51.
2. Forster AJ, Murff HJ, Peterson JF, et al. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med 2003;138:161–7.
3. Forster AJ, Murff HJ, Peterson JF, et al. Adverse drug events occurring following hospital discharge. J Gen Intern Med 2005;20:317–23.
4. Kripalani S, LeFevre F, Phillips CO, et al. Deficits in communication and information transfer between hospital-based and primary care physicians: implications for patient safety and continuity of care. JAMA 2007;297:831–41.
5. Bell CM, Schnipper JL, Auerbach AD, et al. Association of communication between hospital-based physicians and primary care providers with patient outcomes. J Gen Intern Med 2009;24:381–6.
6. van Walraven C, Seth R, Austin PC, Laupacis A. Effect of discharge summary availability during post-discharge visits on hospital readmission. J Gen Intern Med 2002;17:186-92.
7. Horwitz LI, Jenq GY, Brewster UC, et al. Comprehensive quality of discharge summaries at an academic medical center. J Hosp Med 2013;8:436–43.
8. van Walraven C, Rokosh E. What is necessary for high-quality discharge summaries? Am J Med Qual 1999;14:160–9.
9. van Walraven C, Duke SM, Weinberg AL, Wells PS. Standardized or narrative discharge summaries. Which do family physicians prefer? Can Fam Physician 1998;44:62–9.
10. Sheu L, Fung K, Mourad M, et al. We need to talk: Primary care provider communication at discharge in the era of a shared electronic medical record. J Hosp Med 2015;10:307–10.
11. Jones CD, Vu MB, O’Donnell CM, et al. A failure to communicate: a qualitative exploration of care coordination between hospitalists and primary care providers around patient hospitalizations. J Gen Intern Med 2015;30:417–24.
12. Kind AJH, Smith MA. Documentation of mandated discharge summary components in transitions from acute to subacute care. In: Henriksen K, Battles JB, Keyes MA, Grady ML, editors. Advances in patient safety: new directions and alternative approaches (Vol 2: Culture and Redesign). Rockville, MD: Agency for Healthcare Quality and Research; 2008.
13. Kind AJ, Thorpe CT, Sattin JA, et al. Provider characteristics, clinical-work processes and their relationship to discharge summary quality for sub-acute care patients. J Gen Intern Med 2012;27:78–84.
14. Roy CL, Poon EG, Karson AS, et al. Patient safety concerns arising from test results that return after hospital discharge. Ann Intern Med 2005;143:121–8.
15. Were MC, Li X, Kesterson J, et al. Adequacy of hospital discharge summaries in documenting tests with pending results and outpatient follow-up providers. J Gen Intern Med 2009;24:1002–6.
16. Walz SE, Smith M, Cox E, et al. Pending laboratory tests and the hospital discharge summary in patients discharged to sub-acute care. J Gen Intern Med 2011;26:393–8.
17. Kantor MA, Evans KH, Shieh L. Pending studies at hospital discharge: a pre-post analysis of an electronic medical record tool to improve communication at hospital discharge. J Gen Intern Med 2015;30:312–8.
18. Moore C, McGinn T, Halm E. Tying up loose ends: discharging patients with unresolved medical issues. Arch Intern Med 2007;167:1305–11.
19. Al-Damluji MS, Dzara K, Hodshon B, et al. Hospital variation in quality of discharge summaries for patients hospitalized with heart failure exacerbation. Circulation Cardiovasc Qual Outcomes 2015;8:77–86.
20. Coleman EA, Smith JD, Raha D, Min SJ. Posthospital medication discrepancies: prevalence and contributing factors. Arch Intern Med 2005;165:1842–7.
21. Lindquist LA, Yamahiro A, Garrett A, et al. Primary care physician communication at hospital discharge reduces medication discrepancies. J Hosp Med 2013;8:672–7.
22. Snow V, Beck D, Budnitz T, et al. Transitions of care consensus policy statement: American College of Physicians, Society of General Internal Medicine, Society of Hospital Medicine, American Geriatrics Society, American College of Emergency Physicians, and Society for Academic Emergency Medicine. J Hosp Med 2009;4:364–70.
23. O’Leary KJ, Liebovitz DM, Feinglass J, et al. Creating a better discharge summary: improvement in quality and timeliness using an electronic discharge summary. J Hosp Med 2009;4:219–25.
24. Bischoff K, Goel A, Hollander H, et al. The Housestaff Incentive Program: improving the timeliness and quality of discharge summaries by engaging residents in quality improvement. BMJ Qual Safety 2013;22:768–74.
25. Lenert LA, Sakaguchi FH, Weir CR. Rethinking the discharge summary: a focus on handoff communication. Acad Med 2014;89:393–8.
26. Halasyamani L, Kripalani S, Coleman E, et al. Transition of care for hospitalized elderly patients--development of a discharge checklist for hospitalists. J Hosp Med 2006;1:354–60.
27. Kripalani S, Jackson AT, Schnipper JL, Coleman EA. Promoting effective transitions of care at hospital discharge: a review of key issues for hospitalists. J Hosp Med 2007;2:314–23.
28. Huijberts S, Buurman BM, de Rooij SE. End-of-life care during and after an acute hospitalization in older patients with cancer, end-stage organ failure, or frailty: A sub-analysis of a prospective cohort study. Palliat Med 2016;30:75–82.
29. Butler J, Binney Z, Kalogeropoulos A, et al. Advance directives among hospitalized patients with heart failure. JACC Heart Fail 2015;3:112–21.
30. Oulton J, Rhodes SM, Howe C, et al. Advance directives for older adults in the emergency department: a systematic review. J Palliat Med 2015;18:500–5.
31. Shaikh U, Slee C. Triple duty: integrating graduate medical education with maintenance of board certification to improve clinician communication at hospital discharge. J Grad Med Educ 2015;7:462–5.
32. Weis JM, Levy PC. Copy, paste, and cloned notes in electronic health records: prevalence, benefits, risks, and best practice recommendations. Chest 2014;145:632–8.
33. Dixon DR. The behavioral side of information technology. Int J Med Inform 1999;56:117–23.
34. Hommos MS, Kuperman EF, Kamath A, Kreiter CD. The development and evaluation of a novel instrument assessing residents’ discharge summaries. Acad Med 2017;92:550–5.
1. Moore C, Wisnivesky J, Williams S, McGinn T. Medical errors related to discontinuity of care from an inpatient to an outpatient setting. J Gen Intern Med 2003;18:646–51.
2. Forster AJ, Murff HJ, Peterson JF, et al. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med 2003;138:161–7.
3. Forster AJ, Murff HJ, Peterson JF, et al. Adverse drug events occurring following hospital discharge. J Gen Intern Med 2005;20:317–23.
4. Kripalani S, LeFevre F, Phillips CO, et al. Deficits in communication and information transfer between hospital-based and primary care physicians: implications for patient safety and continuity of care. JAMA 2007;297:831–41.
5. Bell CM, Schnipper JL, Auerbach AD, et al. Association of communication between hospital-based physicians and primary care providers with patient outcomes. J Gen Intern Med 2009;24:381–6.
6. van Walraven C, Seth R, Austin PC, Laupacis A. Effect of discharge summary availability during post-discharge visits on hospital readmission. J Gen Intern Med 2002;17:186-92.
7. Horwitz LI, Jenq GY, Brewster UC, et al. Comprehensive quality of discharge summaries at an academic medical center. J Hosp Med 2013;8:436–43.
8. van Walraven C, Rokosh E. What is necessary for high-quality discharge summaries? Am J Med Qual 1999;14:160–9.
9. van Walraven C, Duke SM, Weinberg AL, Wells PS. Standardized or narrative discharge summaries. Which do family physicians prefer? Can Fam Physician 1998;44:62–9.
10. Sheu L, Fung K, Mourad M, et al. We need to talk: Primary care provider communication at discharge in the era of a shared electronic medical record. J Hosp Med 2015;10:307–10.
11. Jones CD, Vu MB, O’Donnell CM, et al. A failure to communicate: a qualitative exploration of care coordination between hospitalists and primary care providers around patient hospitalizations. J Gen Intern Med 2015;30:417–24.
12. Kind AJH, Smith MA. Documentation of mandated discharge summary components in transitions from acute to subacute care. In: Henriksen K, Battles JB, Keyes MA, Grady ML, editors. Advances in patient safety: new directions and alternative approaches (Vol 2: Culture and Redesign). Rockville, MD: Agency for Healthcare Quality and Research; 2008.
13. Kind AJ, Thorpe CT, Sattin JA, et al. Provider characteristics, clinical-work processes and their relationship to discharge summary quality for sub-acute care patients. J Gen Intern Med 2012;27:78–84.
14. Roy CL, Poon EG, Karson AS, et al. Patient safety concerns arising from test results that return after hospital discharge. Ann Intern Med 2005;143:121–8.
15. Were MC, Li X, Kesterson J, et al. Adequacy of hospital discharge summaries in documenting tests with pending results and outpatient follow-up providers. J Gen Intern Med 2009;24:1002–6.
16. Walz SE, Smith M, Cox E, et al. Pending laboratory tests and the hospital discharge summary in patients discharged to sub-acute care. J Gen Intern Med 2011;26:393–8.
17. Kantor MA, Evans KH, Shieh L. Pending studies at hospital discharge: a pre-post analysis of an electronic medical record tool to improve communication at hospital discharge. J Gen Intern Med 2015;30:312–8.
18. Moore C, McGinn T, Halm E. Tying up loose ends: discharging patients with unresolved medical issues. Arch Intern Med 2007;167:1305–11.
19. Al-Damluji MS, Dzara K, Hodshon B, et al. Hospital variation in quality of discharge summaries for patients hospitalized with heart failure exacerbation. Circulation Cardiovasc Qual Outcomes 2015;8:77–86.
20. Coleman EA, Smith JD, Raha D, Min SJ. Posthospital medication discrepancies: prevalence and contributing factors. Arch Intern Med 2005;165:1842–7.
21. Lindquist LA, Yamahiro A, Garrett A, et al. Primary care physician communication at hospital discharge reduces medication discrepancies. J Hosp Med 2013;8:672–7.
22. Snow V, Beck D, Budnitz T, et al. Transitions of care consensus policy statement: American College of Physicians, Society of General Internal Medicine, Society of Hospital Medicine, American Geriatrics Society, American College of Emergency Physicians, and Society for Academic Emergency Medicine. J Hosp Med 2009;4:364–70.
23. O’Leary KJ, Liebovitz DM, Feinglass J, et al. Creating a better discharge summary: improvement in quality and timeliness using an electronic discharge summary. J Hosp Med 2009;4:219–25.
24. Bischoff K, Goel A, Hollander H, et al. The Housestaff Incentive Program: improving the timeliness and quality of discharge summaries by engaging residents in quality improvement. BMJ Qual Safety 2013;22:768–74.
25. Lenert LA, Sakaguchi FH, Weir CR. Rethinking the discharge summary: a focus on handoff communication. Acad Med 2014;89:393–8.
26. Halasyamani L, Kripalani S, Coleman E, et al. Transition of care for hospitalized elderly patients--development of a discharge checklist for hospitalists. J Hosp Med 2006;1:354–60.
27. Kripalani S, Jackson AT, Schnipper JL, Coleman EA. Promoting effective transitions of care at hospital discharge: a review of key issues for hospitalists. J Hosp Med 2007;2:314–23.
28. Huijberts S, Buurman BM, de Rooij SE. End-of-life care during and after an acute hospitalization in older patients with cancer, end-stage organ failure, or frailty: A sub-analysis of a prospective cohort study. Palliat Med 2016;30:75–82.
29. Butler J, Binney Z, Kalogeropoulos A, et al. Advance directives among hospitalized patients with heart failure. JACC Heart Fail 2015;3:112–21.
30. Oulton J, Rhodes SM, Howe C, et al. Advance directives for older adults in the emergency department: a systematic review. J Palliat Med 2015;18:500–5.
31. Shaikh U, Slee C. Triple duty: integrating graduate medical education with maintenance of board certification to improve clinician communication at hospital discharge. J Grad Med Educ 2015;7:462–5.
32. Weis JM, Levy PC. Copy, paste, and cloned notes in electronic health records: prevalence, benefits, risks, and best practice recommendations. Chest 2014;145:632–8.
33. Dixon DR. The behavioral side of information technology. Int J Med Inform 1999;56:117–23.
34. Hommos MS, Kuperman EF, Kamath A, Kreiter CD. The development and evaluation of a novel instrument assessing residents’ discharge summaries. Acad Med 2017;92:550–5.
Factors Impacting Receipt of Weight Loss Advice from Providers Among Patients with Overweight/Obesity
Study Overview
Objective. To examine receipt of provider advice to lose weight among primary care patients who are overweight or obese.
Design. Cross-sectional study.
Setting and participants. Participants were recruited through convenience sampling of primary care practices that were members in a national practice-based research network or part of federally qualified health care system based in the Southeastern United States. Each practice used 1 or more of the following recruitment strategies: self-referral from study flyers posted in practices, given during clinic appointments, or posted on the practice portal (n = 3 practices); mailed invitations to patients part of a practice registry (n = 7 practices); and on-site recruitment by research staff during clinic hours (n = 2 practices). Inclusion criteria included having at least a 3-year history of being a patient in the practice, being aged 18 years or older, and having an overweight or obese status according to Centers for Disease Control definitions (body mass index [BMI] 25.0–29.9 kg/m2 = overweight, ≥ 30 kg/m2 = obese). After completing informed consent, participants completed an interview comprising a 20-minute survey, either in English or Spanish, either in-person or by telephone.
Measures. The survey obtained measures related to sociodemographic characteristics (race, gender, age, marital status, education level, employment status, income level), clinical characteristics (height and weight, history of diabetes/hypertension), psychological variables (readiness to make weight loss or maintenance efforts and confidence in their ability to lose or maintain weight), shared decision-making about weight loss/management (using the SDM-Q-9, with a higher total score indicating greater shared decision-making), and physician advice about weight loss (whether they had ever been advised by a doctor or other health care professional to lose weight or reduce their weight).
Main results. Among the study sample (n = 282), 65% were female, 60% were from racial and ethnic minority groups, 55% were married, 57% had some college education or higher, and 37% had an income level below $20,000/year. The mean age of participants was 53.1 (± 14.4) years. 59% had been advised by their physician to lose weight.
The percentage of participants who reported receiving provider advice was statistically different from 50% using the binomial test (P = 0.0035). Based on bivariate analysis of provider advice about weight loss, women were significantly more likely than men to report that their provider had advised them to lose weight (P = 0.001). Both actual and perceived obesity were associated significantly with receiving provider advice about weight loss (both P = 0.001). Diabetic patients were also significantly more likely than nondiabetic patients to report that their provider had advised them to lose weight (P = 0.01). Participants who reported greater readiness to lose or maintain their weight were more likely to report provider advice about weight loss compared to those with less readiness (P = 0.003). While employed patients, those who had at least some college education, and those who were hypertensive were more likely to report provider advice compared to those who were unemployed, had less education, and were not hypertensive, these associations were not statistically significant (P = 0.06, P = 0.06, P = 0.10, respectively). There were no racial/ethnic differences in receipt of provider advice to lose weight (P = 0.76). Participants with greater shared decision-making were more likely to report provider advice about weight loss (P < 0.001).
Based on results of the multivariate logistic regression analysis, obesity status, perceived obesity, and SDM about weight loss/management had significant independent associations with receiving physician advice about weight loss. Participants with obesity were more likely than those with overweight status to report provider advice (odds ratio [OR] = 1.31, 95% CI = 1.25–4.34, P = 0.001). Similarly, participants who believed they had overweight/obesity had a greater likelihood of reporting provider advice compared with those who did not believe they were obese/overweight (OR = 1.40, 95% CI = 2.43–6.37, P < 0.001). Shared decision making about weight loss/management was associated with an increased likelihood of reporting provider advice (OR = 3.30, 95% CI = 2.62–4.12, P < 0.001).
Conclusions. Many patients with overweight/obesity may not be receiving advice to lose/manage their weight by their provider. While providers should advise patients with overweight/obesity about weight loss and management, patient beliefs about their weight status and perceptions about shared decision-making are important to reporting receipt of provider advice about weight loss/management. Patient beliefs as well as provider behaviors should be addressed as part of efforts to improve the management of obesity/overweight in primary care.
Commentary
Over 35% of adults in the United States have a BMI in the obese range [1], putting them at risk for obesity-related comorbidities [2], often diagnosed and treated within primary care settings. The US Preventive Services Task Force recommends that all patients be screened for obesity and offered intensive lifestyle counseling, since modest weight loss can have significant health benefits [3]. Providers, particularly within the primary care setting, are ideally situated to promote weight loss via effective obesity counseling, as multiple clinic visits over time have the potential to enable rapport building and behavioral change management [4]. Indeed, a 2013 systematic review and meta-analysis of published studies of survey data examining provider weight loss counseling and its association with changes in patient weight loss behavior found that primary care provider advice on weight loss appears to have a significant impact on patient attempts to change behaviors related to their weight [5]. In this study, the authors reported higher rates of physician advice about weight loss compared to other studies, however, the results still demonstrate that based on patient reporting, not all providers are advising weight management or weight loss. Several studies have discussed barriers to weight management and obesity counseling among adults by physicians, which include lack of training, time, and perceived ineffectiveness of their own efforts [6–8].
Additionally, and perhaps more importantly, different factors can impact patient perception of provider advice and/or counseling around weight management, weight loss, or obesity. These can include race/ethnicity [9], health literacy [10], and motivation [11]. This study adds to the literature by shedding new light on variables that are important to patients being advised by providers to lose/manage their weight, including actual and perceived obesity status, and perceived shared decision-making. Previous research has focused on patient-provider communication and shared decision-making in the areas of antibiotic use [12], diabetes management [13], and weight loss [14].
Strengths of this study included the variety of recruitment methods employed to enroll patients from multiple clinic sites, the diverse sociodemographic characteristics of the study sample that resulted, the assessment of variables using standard or previously used measures, and the use of both bivariate and multivariate analyses to assess relationships between variables. Key limitations were acknowledged by the authors and included the cross-sectional design, which does not allow for causality to be assessed; the use of surveys for data collection, which relies on subjective and self-reported data; the assessment of weight management/loss advice only from the perspective of the patient, as opposed to including the provider perspective or using objective observations/data; and the lack of assessment of advice content or frequency of advice given.
Applications for Clinical Practice
As the authors suggest, this study highlights opportunities for improving weight-related advice for patients. Providers should incorporate obesity screening and counseling with all patients, as recommended by clinical care guidelines and the literature. In weight management conversations, providers should also be mindful of patient beliefs and understanding of their weight status, and incorporate shared decision-making practices to increase patient self-efficacy (ie, confidence, readiness) to make weight loss efforts.)
1. Flegal KM, Kruszon-Moran D, Carroll MD, et al. Trends in obesity among adults in the United States, 2005 to 2014. JAMA 2016;315:2284–91.
2. Guh DP, Zhang W, Bansback N, et al. The incidence of co-morbidities related to obesity and overweight: a systematic review and meta-analysis. BMC Public Health 2009;9:88.
3. Moyer VA. Screening for and management of obesity in adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med 2012;157:373–8.
4. Schlair S, Moore S, Mcmacken M, Jay M. How to deliver high quality obesity counseling using the 5As framework. J Clin Outcomes Manag 2012;19:221–9.
5. Rose SA, Poynter PS, Anderson JW, et al. Physician weight loss advice and patient weight loss behavior change: a literature review and meta-analysis of survey data. Int J Obes (Lond) 2013;37:118–28.
6. Forman-Hoffman V, Little A, Wahls T. Barriers to obesity management: a pilot study of primary care clinicians. BMC Fam Pract 2006;7:35.
7. Jay M, Gillespie C, Ark T, et al. Do internists, pediatricians, and psychiatrists feel competent in obesity care? Using a needs assessment to drive curriculum design. J Gen Intern Med 2008;23:1066–70.
8. Leverence RR, Williams RL, Sussman A, Crabtree BF. Obesity counseling and guidelines in primary care: a qualitative study. Am J Prev Med 2007;32:334–9.
9. Durant NH, Bartman B, Person SD, et al. Patient provider communication about the health effects of obesity. Patient Educ Couns 2009;75:53–7.
10. Zarcadoolas C, Levy, J, Sealy Y, et al. Health literacy at work to address overweight and obesity in adults: The development of the Obesity Action Kit. J Commun Health 2011;4:88–101.
11. Befort CA, Greiner KA, Hall S, et al. Weight-related perceptions among patients and physicians: how well do physicians judge patients’ motivation to lose weight? J Gen Intern Med 2006;21:1086–90.
12. Schoenthaler A, Albright G, Hibbard J, Goldman R. Simulated conversations with virtual humans to improve patient-provider communication and reduce unnecessary prescriptions for antibiotics: a repeated measure pilot study. JMIR Med Educ 2017;3:e7.
13. Griffith M, Siminerio L, Payne T, Krall J. A shared decision-making approach to telemedicine: engaging rural patients in glycemic management. J Clin Med 2016;5:103.
14. Carcone AI, Naar-King S, E. Brogan K, et al. Provider communication behaviors that predict motivation to change in black adolescents with obesity. J Dev Behav Pediatr 2013;34:599–608.
Study Overview
Objective. To examine receipt of provider advice to lose weight among primary care patients who are overweight or obese.
Design. Cross-sectional study.
Setting and participants. Participants were recruited through convenience sampling of primary care practices that were members in a national practice-based research network or part of federally qualified health care system based in the Southeastern United States. Each practice used 1 or more of the following recruitment strategies: self-referral from study flyers posted in practices, given during clinic appointments, or posted on the practice portal (n = 3 practices); mailed invitations to patients part of a practice registry (n = 7 practices); and on-site recruitment by research staff during clinic hours (n = 2 practices). Inclusion criteria included having at least a 3-year history of being a patient in the practice, being aged 18 years or older, and having an overweight or obese status according to Centers for Disease Control definitions (body mass index [BMI] 25.0–29.9 kg/m2 = overweight, ≥ 30 kg/m2 = obese). After completing informed consent, participants completed an interview comprising a 20-minute survey, either in English or Spanish, either in-person or by telephone.
Measures. The survey obtained measures related to sociodemographic characteristics (race, gender, age, marital status, education level, employment status, income level), clinical characteristics (height and weight, history of diabetes/hypertension), psychological variables (readiness to make weight loss or maintenance efforts and confidence in their ability to lose or maintain weight), shared decision-making about weight loss/management (using the SDM-Q-9, with a higher total score indicating greater shared decision-making), and physician advice about weight loss (whether they had ever been advised by a doctor or other health care professional to lose weight or reduce their weight).
Main results. Among the study sample (n = 282), 65% were female, 60% were from racial and ethnic minority groups, 55% were married, 57% had some college education or higher, and 37% had an income level below $20,000/year. The mean age of participants was 53.1 (± 14.4) years. 59% had been advised by their physician to lose weight.
The percentage of participants who reported receiving provider advice was statistically different from 50% using the binomial test (P = 0.0035). Based on bivariate analysis of provider advice about weight loss, women were significantly more likely than men to report that their provider had advised them to lose weight (P = 0.001). Both actual and perceived obesity were associated significantly with receiving provider advice about weight loss (both P = 0.001). Diabetic patients were also significantly more likely than nondiabetic patients to report that their provider had advised them to lose weight (P = 0.01). Participants who reported greater readiness to lose or maintain their weight were more likely to report provider advice about weight loss compared to those with less readiness (P = 0.003). While employed patients, those who had at least some college education, and those who were hypertensive were more likely to report provider advice compared to those who were unemployed, had less education, and were not hypertensive, these associations were not statistically significant (P = 0.06, P = 0.06, P = 0.10, respectively). There were no racial/ethnic differences in receipt of provider advice to lose weight (P = 0.76). Participants with greater shared decision-making were more likely to report provider advice about weight loss (P < 0.001).
Based on results of the multivariate logistic regression analysis, obesity status, perceived obesity, and SDM about weight loss/management had significant independent associations with receiving physician advice about weight loss. Participants with obesity were more likely than those with overweight status to report provider advice (odds ratio [OR] = 1.31, 95% CI = 1.25–4.34, P = 0.001). Similarly, participants who believed they had overweight/obesity had a greater likelihood of reporting provider advice compared with those who did not believe they were obese/overweight (OR = 1.40, 95% CI = 2.43–6.37, P < 0.001). Shared decision making about weight loss/management was associated with an increased likelihood of reporting provider advice (OR = 3.30, 95% CI = 2.62–4.12, P < 0.001).
Conclusions. Many patients with overweight/obesity may not be receiving advice to lose/manage their weight by their provider. While providers should advise patients with overweight/obesity about weight loss and management, patient beliefs about their weight status and perceptions about shared decision-making are important to reporting receipt of provider advice about weight loss/management. Patient beliefs as well as provider behaviors should be addressed as part of efforts to improve the management of obesity/overweight in primary care.
Commentary
Over 35% of adults in the United States have a BMI in the obese range [1], putting them at risk for obesity-related comorbidities [2], often diagnosed and treated within primary care settings. The US Preventive Services Task Force recommends that all patients be screened for obesity and offered intensive lifestyle counseling, since modest weight loss can have significant health benefits [3]. Providers, particularly within the primary care setting, are ideally situated to promote weight loss via effective obesity counseling, as multiple clinic visits over time have the potential to enable rapport building and behavioral change management [4]. Indeed, a 2013 systematic review and meta-analysis of published studies of survey data examining provider weight loss counseling and its association with changes in patient weight loss behavior found that primary care provider advice on weight loss appears to have a significant impact on patient attempts to change behaviors related to their weight [5]. In this study, the authors reported higher rates of physician advice about weight loss compared to other studies, however, the results still demonstrate that based on patient reporting, not all providers are advising weight management or weight loss. Several studies have discussed barriers to weight management and obesity counseling among adults by physicians, which include lack of training, time, and perceived ineffectiveness of their own efforts [6–8].
Additionally, and perhaps more importantly, different factors can impact patient perception of provider advice and/or counseling around weight management, weight loss, or obesity. These can include race/ethnicity [9], health literacy [10], and motivation [11]. This study adds to the literature by shedding new light on variables that are important to patients being advised by providers to lose/manage their weight, including actual and perceived obesity status, and perceived shared decision-making. Previous research has focused on patient-provider communication and shared decision-making in the areas of antibiotic use [12], diabetes management [13], and weight loss [14].
Strengths of this study included the variety of recruitment methods employed to enroll patients from multiple clinic sites, the diverse sociodemographic characteristics of the study sample that resulted, the assessment of variables using standard or previously used measures, and the use of both bivariate and multivariate analyses to assess relationships between variables. Key limitations were acknowledged by the authors and included the cross-sectional design, which does not allow for causality to be assessed; the use of surveys for data collection, which relies on subjective and self-reported data; the assessment of weight management/loss advice only from the perspective of the patient, as opposed to including the provider perspective or using objective observations/data; and the lack of assessment of advice content or frequency of advice given.
Applications for Clinical Practice
As the authors suggest, this study highlights opportunities for improving weight-related advice for patients. Providers should incorporate obesity screening and counseling with all patients, as recommended by clinical care guidelines and the literature. In weight management conversations, providers should also be mindful of patient beliefs and understanding of their weight status, and incorporate shared decision-making practices to increase patient self-efficacy (ie, confidence, readiness) to make weight loss efforts.)
Study Overview
Objective. To examine receipt of provider advice to lose weight among primary care patients who are overweight or obese.
Design. Cross-sectional study.
Setting and participants. Participants were recruited through convenience sampling of primary care practices that were members in a national practice-based research network or part of federally qualified health care system based in the Southeastern United States. Each practice used 1 or more of the following recruitment strategies: self-referral from study flyers posted in practices, given during clinic appointments, or posted on the practice portal (n = 3 practices); mailed invitations to patients part of a practice registry (n = 7 practices); and on-site recruitment by research staff during clinic hours (n = 2 practices). Inclusion criteria included having at least a 3-year history of being a patient in the practice, being aged 18 years or older, and having an overweight or obese status according to Centers for Disease Control definitions (body mass index [BMI] 25.0–29.9 kg/m2 = overweight, ≥ 30 kg/m2 = obese). After completing informed consent, participants completed an interview comprising a 20-minute survey, either in English or Spanish, either in-person or by telephone.
Measures. The survey obtained measures related to sociodemographic characteristics (race, gender, age, marital status, education level, employment status, income level), clinical characteristics (height and weight, history of diabetes/hypertension), psychological variables (readiness to make weight loss or maintenance efforts and confidence in their ability to lose or maintain weight), shared decision-making about weight loss/management (using the SDM-Q-9, with a higher total score indicating greater shared decision-making), and physician advice about weight loss (whether they had ever been advised by a doctor or other health care professional to lose weight or reduce their weight).
Main results. Among the study sample (n = 282), 65% were female, 60% were from racial and ethnic minority groups, 55% were married, 57% had some college education or higher, and 37% had an income level below $20,000/year. The mean age of participants was 53.1 (± 14.4) years. 59% had been advised by their physician to lose weight.
The percentage of participants who reported receiving provider advice was statistically different from 50% using the binomial test (P = 0.0035). Based on bivariate analysis of provider advice about weight loss, women were significantly more likely than men to report that their provider had advised them to lose weight (P = 0.001). Both actual and perceived obesity were associated significantly with receiving provider advice about weight loss (both P = 0.001). Diabetic patients were also significantly more likely than nondiabetic patients to report that their provider had advised them to lose weight (P = 0.01). Participants who reported greater readiness to lose or maintain their weight were more likely to report provider advice about weight loss compared to those with less readiness (P = 0.003). While employed patients, those who had at least some college education, and those who were hypertensive were more likely to report provider advice compared to those who were unemployed, had less education, and were not hypertensive, these associations were not statistically significant (P = 0.06, P = 0.06, P = 0.10, respectively). There were no racial/ethnic differences in receipt of provider advice to lose weight (P = 0.76). Participants with greater shared decision-making were more likely to report provider advice about weight loss (P < 0.001).
Based on results of the multivariate logistic regression analysis, obesity status, perceived obesity, and SDM about weight loss/management had significant independent associations with receiving physician advice about weight loss. Participants with obesity were more likely than those with overweight status to report provider advice (odds ratio [OR] = 1.31, 95% CI = 1.25–4.34, P = 0.001). Similarly, participants who believed they had overweight/obesity had a greater likelihood of reporting provider advice compared with those who did not believe they were obese/overweight (OR = 1.40, 95% CI = 2.43–6.37, P < 0.001). Shared decision making about weight loss/management was associated with an increased likelihood of reporting provider advice (OR = 3.30, 95% CI = 2.62–4.12, P < 0.001).
Conclusions. Many patients with overweight/obesity may not be receiving advice to lose/manage their weight by their provider. While providers should advise patients with overweight/obesity about weight loss and management, patient beliefs about their weight status and perceptions about shared decision-making are important to reporting receipt of provider advice about weight loss/management. Patient beliefs as well as provider behaviors should be addressed as part of efforts to improve the management of obesity/overweight in primary care.
Commentary
Over 35% of adults in the United States have a BMI in the obese range [1], putting them at risk for obesity-related comorbidities [2], often diagnosed and treated within primary care settings. The US Preventive Services Task Force recommends that all patients be screened for obesity and offered intensive lifestyle counseling, since modest weight loss can have significant health benefits [3]. Providers, particularly within the primary care setting, are ideally situated to promote weight loss via effective obesity counseling, as multiple clinic visits over time have the potential to enable rapport building and behavioral change management [4]. Indeed, a 2013 systematic review and meta-analysis of published studies of survey data examining provider weight loss counseling and its association with changes in patient weight loss behavior found that primary care provider advice on weight loss appears to have a significant impact on patient attempts to change behaviors related to their weight [5]. In this study, the authors reported higher rates of physician advice about weight loss compared to other studies, however, the results still demonstrate that based on patient reporting, not all providers are advising weight management or weight loss. Several studies have discussed barriers to weight management and obesity counseling among adults by physicians, which include lack of training, time, and perceived ineffectiveness of their own efforts [6–8].
Additionally, and perhaps more importantly, different factors can impact patient perception of provider advice and/or counseling around weight management, weight loss, or obesity. These can include race/ethnicity [9], health literacy [10], and motivation [11]. This study adds to the literature by shedding new light on variables that are important to patients being advised by providers to lose/manage their weight, including actual and perceived obesity status, and perceived shared decision-making. Previous research has focused on patient-provider communication and shared decision-making in the areas of antibiotic use [12], diabetes management [13], and weight loss [14].
Strengths of this study included the variety of recruitment methods employed to enroll patients from multiple clinic sites, the diverse sociodemographic characteristics of the study sample that resulted, the assessment of variables using standard or previously used measures, and the use of both bivariate and multivariate analyses to assess relationships between variables. Key limitations were acknowledged by the authors and included the cross-sectional design, which does not allow for causality to be assessed; the use of surveys for data collection, which relies on subjective and self-reported data; the assessment of weight management/loss advice only from the perspective of the patient, as opposed to including the provider perspective or using objective observations/data; and the lack of assessment of advice content or frequency of advice given.
Applications for Clinical Practice
As the authors suggest, this study highlights opportunities for improving weight-related advice for patients. Providers should incorporate obesity screening and counseling with all patients, as recommended by clinical care guidelines and the literature. In weight management conversations, providers should also be mindful of patient beliefs and understanding of their weight status, and incorporate shared decision-making practices to increase patient self-efficacy (ie, confidence, readiness) to make weight loss efforts.)
1. Flegal KM, Kruszon-Moran D, Carroll MD, et al. Trends in obesity among adults in the United States, 2005 to 2014. JAMA 2016;315:2284–91.
2. Guh DP, Zhang W, Bansback N, et al. The incidence of co-morbidities related to obesity and overweight: a systematic review and meta-analysis. BMC Public Health 2009;9:88.
3. Moyer VA. Screening for and management of obesity in adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med 2012;157:373–8.
4. Schlair S, Moore S, Mcmacken M, Jay M. How to deliver high quality obesity counseling using the 5As framework. J Clin Outcomes Manag 2012;19:221–9.
5. Rose SA, Poynter PS, Anderson JW, et al. Physician weight loss advice and patient weight loss behavior change: a literature review and meta-analysis of survey data. Int J Obes (Lond) 2013;37:118–28.
6. Forman-Hoffman V, Little A, Wahls T. Barriers to obesity management: a pilot study of primary care clinicians. BMC Fam Pract 2006;7:35.
7. Jay M, Gillespie C, Ark T, et al. Do internists, pediatricians, and psychiatrists feel competent in obesity care? Using a needs assessment to drive curriculum design. J Gen Intern Med 2008;23:1066–70.
8. Leverence RR, Williams RL, Sussman A, Crabtree BF. Obesity counseling and guidelines in primary care: a qualitative study. Am J Prev Med 2007;32:334–9.
9. Durant NH, Bartman B, Person SD, et al. Patient provider communication about the health effects of obesity. Patient Educ Couns 2009;75:53–7.
10. Zarcadoolas C, Levy, J, Sealy Y, et al. Health literacy at work to address overweight and obesity in adults: The development of the Obesity Action Kit. J Commun Health 2011;4:88–101.
11. Befort CA, Greiner KA, Hall S, et al. Weight-related perceptions among patients and physicians: how well do physicians judge patients’ motivation to lose weight? J Gen Intern Med 2006;21:1086–90.
12. Schoenthaler A, Albright G, Hibbard J, Goldman R. Simulated conversations with virtual humans to improve patient-provider communication and reduce unnecessary prescriptions for antibiotics: a repeated measure pilot study. JMIR Med Educ 2017;3:e7.
13. Griffith M, Siminerio L, Payne T, Krall J. A shared decision-making approach to telemedicine: engaging rural patients in glycemic management. J Clin Med 2016;5:103.
14. Carcone AI, Naar-King S, E. Brogan K, et al. Provider communication behaviors that predict motivation to change in black adolescents with obesity. J Dev Behav Pediatr 2013;34:599–608.
1. Flegal KM, Kruszon-Moran D, Carroll MD, et al. Trends in obesity among adults in the United States, 2005 to 2014. JAMA 2016;315:2284–91.
2. Guh DP, Zhang W, Bansback N, et al. The incidence of co-morbidities related to obesity and overweight: a systematic review and meta-analysis. BMC Public Health 2009;9:88.
3. Moyer VA. Screening for and management of obesity in adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med 2012;157:373–8.
4. Schlair S, Moore S, Mcmacken M, Jay M. How to deliver high quality obesity counseling using the 5As framework. J Clin Outcomes Manag 2012;19:221–9.
5. Rose SA, Poynter PS, Anderson JW, et al. Physician weight loss advice and patient weight loss behavior change: a literature review and meta-analysis of survey data. Int J Obes (Lond) 2013;37:118–28.
6. Forman-Hoffman V, Little A, Wahls T. Barriers to obesity management: a pilot study of primary care clinicians. BMC Fam Pract 2006;7:35.
7. Jay M, Gillespie C, Ark T, et al. Do internists, pediatricians, and psychiatrists feel competent in obesity care? Using a needs assessment to drive curriculum design. J Gen Intern Med 2008;23:1066–70.
8. Leverence RR, Williams RL, Sussman A, Crabtree BF. Obesity counseling and guidelines in primary care: a qualitative study. Am J Prev Med 2007;32:334–9.
9. Durant NH, Bartman B, Person SD, et al. Patient provider communication about the health effects of obesity. Patient Educ Couns 2009;75:53–7.
10. Zarcadoolas C, Levy, J, Sealy Y, et al. Health literacy at work to address overweight and obesity in adults: The development of the Obesity Action Kit. J Commun Health 2011;4:88–101.
11. Befort CA, Greiner KA, Hall S, et al. Weight-related perceptions among patients and physicians: how well do physicians judge patients’ motivation to lose weight? J Gen Intern Med 2006;21:1086–90.
12. Schoenthaler A, Albright G, Hibbard J, Goldman R. Simulated conversations with virtual humans to improve patient-provider communication and reduce unnecessary prescriptions for antibiotics: a repeated measure pilot study. JMIR Med Educ 2017;3:e7.
13. Griffith M, Siminerio L, Payne T, Krall J. A shared decision-making approach to telemedicine: engaging rural patients in glycemic management. J Clin Med 2016;5:103.
14. Carcone AI, Naar-King S, E. Brogan K, et al. Provider communication behaviors that predict motivation to change in black adolescents with obesity. J Dev Behav Pediatr 2013;34:599–608.
Aim for BP a bit above SPRINT
ANAHEIM – If blood pressure isn’t measured the way it was in the SPRINT trial, it shouldn’t be treated all the way down to the SPRINT target of less than 120 mm Hg; it’s best to aim a little higher, according to investigators from Kaiser Permanente of Northern California.
SPRINT (the Systolic Blood Pressure Intervention Trial) found that treating hypertension to below 120 mm Hg – as opposed to below 140 mm Hg – reduced the risk of cardiovascular events and death, but blood pressure wasn’t measured the way it usually is in standard practice. Among other differences, SPRINT subjects rested for 5 minutes beforehand, sometimes unobserved, and then three automated measurements were taken and averaged (N Engl J Med. 2015 Nov 26;373[22]:2103-16).
In a review of 73,522 hypertensive patients, the Kaiser investigators found that those treated to a mean systolic BP (SBP) of 122 mm Hg – based on standard office measurement – actually had worse outcomes than did those treated to a mean of 132 mm Hg, with a greater incidence of cardiovascular events, hypotension, electrolyte abnormalities, and other problems.
“The way SPRINT measured BP was systematically different than the BPs we rely on to treat patients in clinical practice. We think that, unless you are going to implement a SPRINT-like protocol, aiming for a slightly higher target of around a mean of 130-132 mm Hg will achieve optimal outcomes. You are likely achieving a SPRINT BP of around 120-125 mm Hg,” said Alan Go, MD, director of the comprehensive clinical research unit at Kaiser Permanente of Northern California, Oakland.
Meanwhile, “if you [treat] to 120 mm Hg, you are probably getting around a SPRINT 114 mm Hg. That runs the risk of hypotension, which we did see. There is also the potential for coronary ischemia because you are no longer providing adequate coronary perfusion,” he said at the American Heart Association scientific sessions.
In their “SPRINT to translation” study, Dr. Go and his team reviewed Kaiser’s electronic medical records to identify patients with baseline BPs of 130-180 mm Hg who met SPRINT criteria and then evaluated how they fared over about 6 years of blood pressure management, with at least one BP taken every 6 months; 7,213 patients were treated to an SBP of 140-149 mm Hg and a mean of 143 mm Hg; 44,847 were treated to an SBP of 126-139 mm Hg and a mean of 132 mm Hg; and 21,462 were treated to 115-125 mm Hg and a mean of 122 mm Hg.
After extensive adjustment for potential confounders, patients treated to 140-149 mm Hg, versus those treated to 126-139 mm Hg, had a 70% increased risk of the composite outcome of acute MI, unstable angina, heart failure, stroke, and cardiovascular death, and a 28% increased risk of all-cause mortality. They also had an increased risk of acute kidney injury, electrolyte abnormalities, and other problems.
More surprisingly, patients treated to 115-125 mm Hg, again versus those treated to 126-139 mm Hg, also had an increased risk of the composite outcome of 9%. They had lower rates of MI and ischemic stroke, but higher rates of heart failure and cardiovascular death. There was also a 17% increased risk of acute kidney injury and a 51% increased risk of hypotension requiring ED or hospital treatment, as well as more electrolyte abnormalities.
The 115-125 mm Hg group also had a 48% increased risk of all-cause mortality. The magnitude of the increase suggests that low blood pressure was a secondary effect of terminal illness in some cases, but Dr. Go didn’t think that was the entire explanation.
The participants had a mean age of 70 years; 63% were women and 75% were white. As in SPRINT, patients with baseline heart failure, stroke, systolic dysfunction, diabetes, end-stage renal disease, and cancer were among those excluded.
There was no external funding for the work, and the investigators didn’t have any disclosures.
ANAHEIM – If blood pressure isn’t measured the way it was in the SPRINT trial, it shouldn’t be treated all the way down to the SPRINT target of less than 120 mm Hg; it’s best to aim a little higher, according to investigators from Kaiser Permanente of Northern California.
SPRINT (the Systolic Blood Pressure Intervention Trial) found that treating hypertension to below 120 mm Hg – as opposed to below 140 mm Hg – reduced the risk of cardiovascular events and death, but blood pressure wasn’t measured the way it usually is in standard practice. Among other differences, SPRINT subjects rested for 5 minutes beforehand, sometimes unobserved, and then three automated measurements were taken and averaged (N Engl J Med. 2015 Nov 26;373[22]:2103-16).
In a review of 73,522 hypertensive patients, the Kaiser investigators found that those treated to a mean systolic BP (SBP) of 122 mm Hg – based on standard office measurement – actually had worse outcomes than did those treated to a mean of 132 mm Hg, with a greater incidence of cardiovascular events, hypotension, electrolyte abnormalities, and other problems.
“The way SPRINT measured BP was systematically different than the BPs we rely on to treat patients in clinical practice. We think that, unless you are going to implement a SPRINT-like protocol, aiming for a slightly higher target of around a mean of 130-132 mm Hg will achieve optimal outcomes. You are likely achieving a SPRINT BP of around 120-125 mm Hg,” said Alan Go, MD, director of the comprehensive clinical research unit at Kaiser Permanente of Northern California, Oakland.
Meanwhile, “if you [treat] to 120 mm Hg, you are probably getting around a SPRINT 114 mm Hg. That runs the risk of hypotension, which we did see. There is also the potential for coronary ischemia because you are no longer providing adequate coronary perfusion,” he said at the American Heart Association scientific sessions.
In their “SPRINT to translation” study, Dr. Go and his team reviewed Kaiser’s electronic medical records to identify patients with baseline BPs of 130-180 mm Hg who met SPRINT criteria and then evaluated how they fared over about 6 years of blood pressure management, with at least one BP taken every 6 months; 7,213 patients were treated to an SBP of 140-149 mm Hg and a mean of 143 mm Hg; 44,847 were treated to an SBP of 126-139 mm Hg and a mean of 132 mm Hg; and 21,462 were treated to 115-125 mm Hg and a mean of 122 mm Hg.
After extensive adjustment for potential confounders, patients treated to 140-149 mm Hg, versus those treated to 126-139 mm Hg, had a 70% increased risk of the composite outcome of acute MI, unstable angina, heart failure, stroke, and cardiovascular death, and a 28% increased risk of all-cause mortality. They also had an increased risk of acute kidney injury, electrolyte abnormalities, and other problems.
More surprisingly, patients treated to 115-125 mm Hg, again versus those treated to 126-139 mm Hg, also had an increased risk of the composite outcome of 9%. They had lower rates of MI and ischemic stroke, but higher rates of heart failure and cardiovascular death. There was also a 17% increased risk of acute kidney injury and a 51% increased risk of hypotension requiring ED or hospital treatment, as well as more electrolyte abnormalities.
The 115-125 mm Hg group also had a 48% increased risk of all-cause mortality. The magnitude of the increase suggests that low blood pressure was a secondary effect of terminal illness in some cases, but Dr. Go didn’t think that was the entire explanation.
The participants had a mean age of 70 years; 63% were women and 75% were white. As in SPRINT, patients with baseline heart failure, stroke, systolic dysfunction, diabetes, end-stage renal disease, and cancer were among those excluded.
There was no external funding for the work, and the investigators didn’t have any disclosures.
ANAHEIM – If blood pressure isn’t measured the way it was in the SPRINT trial, it shouldn’t be treated all the way down to the SPRINT target of less than 120 mm Hg; it’s best to aim a little higher, according to investigators from Kaiser Permanente of Northern California.
SPRINT (the Systolic Blood Pressure Intervention Trial) found that treating hypertension to below 120 mm Hg – as opposed to below 140 mm Hg – reduced the risk of cardiovascular events and death, but blood pressure wasn’t measured the way it usually is in standard practice. Among other differences, SPRINT subjects rested for 5 minutes beforehand, sometimes unobserved, and then three automated measurements were taken and averaged (N Engl J Med. 2015 Nov 26;373[22]:2103-16).
In a review of 73,522 hypertensive patients, the Kaiser investigators found that those treated to a mean systolic BP (SBP) of 122 mm Hg – based on standard office measurement – actually had worse outcomes than did those treated to a mean of 132 mm Hg, with a greater incidence of cardiovascular events, hypotension, electrolyte abnormalities, and other problems.
“The way SPRINT measured BP was systematically different than the BPs we rely on to treat patients in clinical practice. We think that, unless you are going to implement a SPRINT-like protocol, aiming for a slightly higher target of around a mean of 130-132 mm Hg will achieve optimal outcomes. You are likely achieving a SPRINT BP of around 120-125 mm Hg,” said Alan Go, MD, director of the comprehensive clinical research unit at Kaiser Permanente of Northern California, Oakland.
Meanwhile, “if you [treat] to 120 mm Hg, you are probably getting around a SPRINT 114 mm Hg. That runs the risk of hypotension, which we did see. There is also the potential for coronary ischemia because you are no longer providing adequate coronary perfusion,” he said at the American Heart Association scientific sessions.
In their “SPRINT to translation” study, Dr. Go and his team reviewed Kaiser’s electronic medical records to identify patients with baseline BPs of 130-180 mm Hg who met SPRINT criteria and then evaluated how they fared over about 6 years of blood pressure management, with at least one BP taken every 6 months; 7,213 patients were treated to an SBP of 140-149 mm Hg and a mean of 143 mm Hg; 44,847 were treated to an SBP of 126-139 mm Hg and a mean of 132 mm Hg; and 21,462 were treated to 115-125 mm Hg and a mean of 122 mm Hg.
After extensive adjustment for potential confounders, patients treated to 140-149 mm Hg, versus those treated to 126-139 mm Hg, had a 70% increased risk of the composite outcome of acute MI, unstable angina, heart failure, stroke, and cardiovascular death, and a 28% increased risk of all-cause mortality. They also had an increased risk of acute kidney injury, electrolyte abnormalities, and other problems.
More surprisingly, patients treated to 115-125 mm Hg, again versus those treated to 126-139 mm Hg, also had an increased risk of the composite outcome of 9%. They had lower rates of MI and ischemic stroke, but higher rates of heart failure and cardiovascular death. There was also a 17% increased risk of acute kidney injury and a 51% increased risk of hypotension requiring ED or hospital treatment, as well as more electrolyte abnormalities.
The 115-125 mm Hg group also had a 48% increased risk of all-cause mortality. The magnitude of the increase suggests that low blood pressure was a secondary effect of terminal illness in some cases, but Dr. Go didn’t think that was the entire explanation.
The participants had a mean age of 70 years; 63% were women and 75% were white. As in SPRINT, patients with baseline heart failure, stroke, systolic dysfunction, diabetes, end-stage renal disease, and cancer were among those excluded.
There was no external funding for the work, and the investigators didn’t have any disclosures.
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: Cardiovascular events were 9% more likely in patients treated to 115-125 mm Hg vs. those treated to 126-139 mm Hg.
Data source: Review of 73,522 hypertensive patients at Kaiser Permanente of Northern California
Disclosures: There was no external funding for the work, and the investigators had no disclosures.
Anabasum shows promise in treating skin-predominant dermatomyositis, systemic sclerosis
SAN DIEGO – Results from two phase 2 studies of the investigational agent anabasum provide evidence supporting its safety and efficacy in patients with refractory skin-predominant dermatomyositis or diffuse cutaneous systemic sclerosis.
Anabasum (JBT-101) is a nonimmunosuppressive, synthetic, oral cannabinoid receptor type 2 agonist being developed by Norwood, Mass.–based Corbus Pharmaceuticals. It works by triggering resolution of innate immune responses, said Barbara White, MD, a rheumatologist who is chief medical officer for Corbus. “It restores homeostasis, gets rid of inflammation, turns off active fibrotic processes, and helps clear bacteria if it is present – all without immunosuppression,” she explained in an interview at the annual meeting of the American College of Rheumatology. “A drug that would restore homeostasis in the setting of an ongoing immune response has the potential to be helpful in multiple autoimmune diseases.”
The mean age of the study participants was 53 years and most were white. Even though 19 of the patients were on immunosuppressants at baseline, both cohorts had mean CDASI scores in the 33-35 range, which can be considered severe.
The investigators, led by Victoria P. Werth, MD, of the University of Pennsylvania, Philadelphia, reported that anabasum-treated subjects experienced a medically meaningful improvement in mean CDASI scores, with a reduction of at least 5 points at all visits after week 4 and reaching –9.3 at the end of the study, compared with –3.7 points in the placebo group (P = .02). They also found that 56% of subjects in the anabasum group had a 10-point reduction or more in CDASI score, compared with only 18% in the placebo group (P = .09). In addition, no subjects in the anabasum group developed skin erosions during the active dosing period, compared with 36% of subjects in the placebo group (P = .05).
The researchers also observed that, compared with subjects in the placebo group, those in the anabasum group had greater improvement in patient-reported global skin disease and overall disease assessments, skin symptoms (including photosensitivity and itch), fatigue, sleep, interference with activities, pain, and physical function. No serious, severe, or unexpected adverse events occurred in the anabasum group. Adverse events included dizziness, dyspepsia, headache, and increased appetite.
There is not a Food and Drug Administration or European Medicines Agency–approved drug for refractory skin-predominant dermatomyositis, “so this is encouraging,” Dr. White said.
Dr. Spiera reported that patients in the anabasum group had greater improvement in ACR CRISS, compared with placebo-treated subjects over 16 weeks (P = .044). They also had greater improvement and less worsening in individual CRISS core measures, including modified Rodnan Skin Score, Patient Global Assessment, Physician Global Assessment, and the Health Assessment Questionnaire Disability Index. Patient-reported outcomes of systemic sclerosis skin symptoms, itch, and the Patient-Reported Outcomes Measurement Information System–29 (PROMIS-29) domains of physical function, pain interference, and sleep also improved for the anabasum group, compared with the placebo group (P less than .05 for all).
An analysis of paired skin biopsies before and after treatment with the assessor blinded to treatment assignment demonstrated that patients treated with anabasum were more likely to show improvement in fibrosis and inflammation and less likely to show worsening than were those treated with placebo, consistent with what was observed clinically. In a related poster presented at the meeting, gene expression analysis from specimens before and after treatment also revealed that anabasum treatment (as opposed to treatment with placebo) was associated with changes relevant to pathways involved in fibrosis and inflammation.
“This is the first double-blind, randomized, placebo controlled trial in diffuse cutaneous systemic sclerosis to demonstrate a clinical benefit using the CRISS as an endpoint, with a drug that was safe and well tolerated in the trial,” Dr. Spiera said. “These results bring hope to patients and their physicians that anabasum may be an effective drug for systemic sclerosis where currently there are no proven treatments.”
Both studies were sponsored by Corbus, and the dermatomyositis study was also sponsored by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Some of the investigators in both studies were employees of Corbus. Dr. Spiera reported receiving research support from Corbus and many other pharmaceutical companies. He also is a consultant to Roche-Genentech, GlaxoSmithKline, Boehringer Ingelheim, and CSL Behring. He is a member of the Rheumatology News editorial advisory board.
SAN DIEGO – Results from two phase 2 studies of the investigational agent anabasum provide evidence supporting its safety and efficacy in patients with refractory skin-predominant dermatomyositis or diffuse cutaneous systemic sclerosis.
Anabasum (JBT-101) is a nonimmunosuppressive, synthetic, oral cannabinoid receptor type 2 agonist being developed by Norwood, Mass.–based Corbus Pharmaceuticals. It works by triggering resolution of innate immune responses, said Barbara White, MD, a rheumatologist who is chief medical officer for Corbus. “It restores homeostasis, gets rid of inflammation, turns off active fibrotic processes, and helps clear bacteria if it is present – all without immunosuppression,” she explained in an interview at the annual meeting of the American College of Rheumatology. “A drug that would restore homeostasis in the setting of an ongoing immune response has the potential to be helpful in multiple autoimmune diseases.”
The mean age of the study participants was 53 years and most were white. Even though 19 of the patients were on immunosuppressants at baseline, both cohorts had mean CDASI scores in the 33-35 range, which can be considered severe.
The investigators, led by Victoria P. Werth, MD, of the University of Pennsylvania, Philadelphia, reported that anabasum-treated subjects experienced a medically meaningful improvement in mean CDASI scores, with a reduction of at least 5 points at all visits after week 4 and reaching –9.3 at the end of the study, compared with –3.7 points in the placebo group (P = .02). They also found that 56% of subjects in the anabasum group had a 10-point reduction or more in CDASI score, compared with only 18% in the placebo group (P = .09). In addition, no subjects in the anabasum group developed skin erosions during the active dosing period, compared with 36% of subjects in the placebo group (P = .05).
The researchers also observed that, compared with subjects in the placebo group, those in the anabasum group had greater improvement in patient-reported global skin disease and overall disease assessments, skin symptoms (including photosensitivity and itch), fatigue, sleep, interference with activities, pain, and physical function. No serious, severe, or unexpected adverse events occurred in the anabasum group. Adverse events included dizziness, dyspepsia, headache, and increased appetite.
There is not a Food and Drug Administration or European Medicines Agency–approved drug for refractory skin-predominant dermatomyositis, “so this is encouraging,” Dr. White said.
Dr. Spiera reported that patients in the anabasum group had greater improvement in ACR CRISS, compared with placebo-treated subjects over 16 weeks (P = .044). They also had greater improvement and less worsening in individual CRISS core measures, including modified Rodnan Skin Score, Patient Global Assessment, Physician Global Assessment, and the Health Assessment Questionnaire Disability Index. Patient-reported outcomes of systemic sclerosis skin symptoms, itch, and the Patient-Reported Outcomes Measurement Information System–29 (PROMIS-29) domains of physical function, pain interference, and sleep also improved for the anabasum group, compared with the placebo group (P less than .05 for all).
An analysis of paired skin biopsies before and after treatment with the assessor blinded to treatment assignment demonstrated that patients treated with anabasum were more likely to show improvement in fibrosis and inflammation and less likely to show worsening than were those treated with placebo, consistent with what was observed clinically. In a related poster presented at the meeting, gene expression analysis from specimens before and after treatment also revealed that anabasum treatment (as opposed to treatment with placebo) was associated with changes relevant to pathways involved in fibrosis and inflammation.
“This is the first double-blind, randomized, placebo controlled trial in diffuse cutaneous systemic sclerosis to demonstrate a clinical benefit using the CRISS as an endpoint, with a drug that was safe and well tolerated in the trial,” Dr. Spiera said. “These results bring hope to patients and their physicians that anabasum may be an effective drug for systemic sclerosis where currently there are no proven treatments.”
Both studies were sponsored by Corbus, and the dermatomyositis study was also sponsored by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Some of the investigators in both studies were employees of Corbus. Dr. Spiera reported receiving research support from Corbus and many other pharmaceutical companies. He also is a consultant to Roche-Genentech, GlaxoSmithKline, Boehringer Ingelheim, and CSL Behring. He is a member of the Rheumatology News editorial advisory board.
SAN DIEGO – Results from two phase 2 studies of the investigational agent anabasum provide evidence supporting its safety and efficacy in patients with refractory skin-predominant dermatomyositis or diffuse cutaneous systemic sclerosis.
Anabasum (JBT-101) is a nonimmunosuppressive, synthetic, oral cannabinoid receptor type 2 agonist being developed by Norwood, Mass.–based Corbus Pharmaceuticals. It works by triggering resolution of innate immune responses, said Barbara White, MD, a rheumatologist who is chief medical officer for Corbus. “It restores homeostasis, gets rid of inflammation, turns off active fibrotic processes, and helps clear bacteria if it is present – all without immunosuppression,” she explained in an interview at the annual meeting of the American College of Rheumatology. “A drug that would restore homeostasis in the setting of an ongoing immune response has the potential to be helpful in multiple autoimmune diseases.”
The mean age of the study participants was 53 years and most were white. Even though 19 of the patients were on immunosuppressants at baseline, both cohorts had mean CDASI scores in the 33-35 range, which can be considered severe.
The investigators, led by Victoria P. Werth, MD, of the University of Pennsylvania, Philadelphia, reported that anabasum-treated subjects experienced a medically meaningful improvement in mean CDASI scores, with a reduction of at least 5 points at all visits after week 4 and reaching –9.3 at the end of the study, compared with –3.7 points in the placebo group (P = .02). They also found that 56% of subjects in the anabasum group had a 10-point reduction or more in CDASI score, compared with only 18% in the placebo group (P = .09). In addition, no subjects in the anabasum group developed skin erosions during the active dosing period, compared with 36% of subjects in the placebo group (P = .05).
The researchers also observed that, compared with subjects in the placebo group, those in the anabasum group had greater improvement in patient-reported global skin disease and overall disease assessments, skin symptoms (including photosensitivity and itch), fatigue, sleep, interference with activities, pain, and physical function. No serious, severe, or unexpected adverse events occurred in the anabasum group. Adverse events included dizziness, dyspepsia, headache, and increased appetite.
There is not a Food and Drug Administration or European Medicines Agency–approved drug for refractory skin-predominant dermatomyositis, “so this is encouraging,” Dr. White said.
Dr. Spiera reported that patients in the anabasum group had greater improvement in ACR CRISS, compared with placebo-treated subjects over 16 weeks (P = .044). They also had greater improvement and less worsening in individual CRISS core measures, including modified Rodnan Skin Score, Patient Global Assessment, Physician Global Assessment, and the Health Assessment Questionnaire Disability Index. Patient-reported outcomes of systemic sclerosis skin symptoms, itch, and the Patient-Reported Outcomes Measurement Information System–29 (PROMIS-29) domains of physical function, pain interference, and sleep also improved for the anabasum group, compared with the placebo group (P less than .05 for all).
An analysis of paired skin biopsies before and after treatment with the assessor blinded to treatment assignment demonstrated that patients treated with anabasum were more likely to show improvement in fibrosis and inflammation and less likely to show worsening than were those treated with placebo, consistent with what was observed clinically. In a related poster presented at the meeting, gene expression analysis from specimens before and after treatment also revealed that anabasum treatment (as opposed to treatment with placebo) was associated with changes relevant to pathways involved in fibrosis and inflammation.
“This is the first double-blind, randomized, placebo controlled trial in diffuse cutaneous systemic sclerosis to demonstrate a clinical benefit using the CRISS as an endpoint, with a drug that was safe and well tolerated in the trial,” Dr. Spiera said. “These results bring hope to patients and their physicians that anabasum may be an effective drug for systemic sclerosis where currently there are no proven treatments.”
Both studies were sponsored by Corbus, and the dermatomyositis study was also sponsored by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Some of the investigators in both studies were employees of Corbus. Dr. Spiera reported receiving research support from Corbus and many other pharmaceutical companies. He also is a consultant to Roche-Genentech, GlaxoSmithKline, Boehringer Ingelheim, and CSL Behring. He is a member of the Rheumatology News editorial advisory board.
AT ACR 2017
Key clinical point: Anabasum had a favorable safety profile and was well tolerated in patients with either refractory skin-predominant dermatomyositis or diffuse cutaneous systemic sclerosis.
Major finding: Treatment with anabasum resulted in greater improvement in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) score at 12 weeks, compared with placebo (–9.3 vs. –3.7 points, respectively; P = .02) and also in the ACR Combined Response Index in Systemic Sclerosis (CRISS) at 16 weeks, compared with placebo (P = .044).
Study details: Two 12-week, phase 2 studies of anabasum in patients with dermatomyositis or systemic sclerosis.
Disclosures: The studies were funded by Corbus, and the dermatomyositis study was additionally supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Spiera reported receiving research support from Corbus and many other pharmaceutical companies. He is a consultant to Roche-Genentech, GlaxoSmithKline, Boehringer Ingelheim, and CSL Behring. Some of the investigators in both studies were employees of Corbus.
Putting Choosing Wisely into practice
At Mount Sinai Hospital, Choosing Wisely’s guidelines for hospital medicine inspired Harry Cho, MD, FACP, and his colleagues to work on the rates of catheter-associated urinary tract infection in their hospital.
They launched their “Lose the Tube” project, creating an electronic catheter identification tool and instituting a daily multidisciplinary query. “On our patient list, we had a column with a green or red dot, indicating if the patient had a catheter or not,” Dr. Cho said. “From there, we wanted to give the onus to the provider. During multidisciplinary rounds, we queried the doctor – we were not ordering them – ‘Does this patient need the Foley?’ After a while, people started coming into multidisciplinary rounds knowing if their patients had a Foley. It was a culture shift.”
“That’s the model that you want to build,” Dr. Cho said. “That’s the culture that you need so that whenever projects like this happen, they just move forward.”
Reference
Cho HJ et al. “Lose the Tube”: A Choosing Wisely initiative to reduce catheter-associated urinary tract infections in hospitalist-led inpatient units. Am J Infect Control. 2017 Mar 1;45(3):333-5.
At Mount Sinai Hospital, Choosing Wisely’s guidelines for hospital medicine inspired Harry Cho, MD, FACP, and his colleagues to work on the rates of catheter-associated urinary tract infection in their hospital.
They launched their “Lose the Tube” project, creating an electronic catheter identification tool and instituting a daily multidisciplinary query. “On our patient list, we had a column with a green or red dot, indicating if the patient had a catheter or not,” Dr. Cho said. “From there, we wanted to give the onus to the provider. During multidisciplinary rounds, we queried the doctor – we were not ordering them – ‘Does this patient need the Foley?’ After a while, people started coming into multidisciplinary rounds knowing if their patients had a Foley. It was a culture shift.”
“That’s the model that you want to build,” Dr. Cho said. “That’s the culture that you need so that whenever projects like this happen, they just move forward.”
Reference
Cho HJ et al. “Lose the Tube”: A Choosing Wisely initiative to reduce catheter-associated urinary tract infections in hospitalist-led inpatient units. Am J Infect Control. 2017 Mar 1;45(3):333-5.
At Mount Sinai Hospital, Choosing Wisely’s guidelines for hospital medicine inspired Harry Cho, MD, FACP, and his colleagues to work on the rates of catheter-associated urinary tract infection in their hospital.
They launched their “Lose the Tube” project, creating an electronic catheter identification tool and instituting a daily multidisciplinary query. “On our patient list, we had a column with a green or red dot, indicating if the patient had a catheter or not,” Dr. Cho said. “From there, we wanted to give the onus to the provider. During multidisciplinary rounds, we queried the doctor – we were not ordering them – ‘Does this patient need the Foley?’ After a while, people started coming into multidisciplinary rounds knowing if their patients had a Foley. It was a culture shift.”
“That’s the model that you want to build,” Dr. Cho said. “That’s the culture that you need so that whenever projects like this happen, they just move forward.”
Reference
Cho HJ et al. “Lose the Tube”: A Choosing Wisely initiative to reduce catheter-associated urinary tract infections in hospitalist-led inpatient units. Am J Infect Control. 2017 Mar 1;45(3):333-5.
CDC Updates Guidance on Infants With Possible Zika Infection
Infants with possible prenatal exposure to Zika who test positive for the virus should receive an in-depth ophthalmologic exam, intensified hearing testing, and a thorough neurologic evaluation with brain imaging within one month of birth, according to new interim guidance from the Centers for Disease Control and Prevention (CDC).
The new clinical management guidelines, published in the October 20 issue of Morbidity and Mortality Weekly Report, supersede the CDC guidance issued in August 2016. The update was the product of a forum on the diagnosis, evaluation, and management of Zika in infants that the centers convened with the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists. Practicing clinicians and federal agency representatives reviewed the evolving body of knowledge on how best to care for these infants. Since Zika emerged as a public health concern, clinicians have reported postnatal onset of some symptoms, including eye abnormalities, incident microcephaly in infants with a normal head circumference at birth, EEG abnormalities, and diaphragmatic paralysis.
Infants With Clinical Findings Consistent With Zika Syndrome
Infants with clinical findings consistent with congenital Zika syndrome who are born to mothers with possible Zika virus exposure in pregnancy should be tested for Zika virus with serum and urine tests. If those tests are negative, and there is no other apparent cause of the symptoms, they should have a CSF sample tested for Zika RNA and IgM Zika antibodies.
By one month, these infants should undergo a head ultrasound and a detailed ophthalmologic exam. The eye exam should pick up any anomalies of the anterior and posterior eye, including microphthalmia, coloboma, intraocular calcifications, optic nerve hypoplasia and atrophy, and macular scarring with focal pigmentary retinal mottling.
By one month, these infants also should undergo auditory brainstem response (ABR) audiometry, especially if the initial newborn hearing screen was done by otoacoustic emissions alone. Zika syndrome can include sensorineural hearing loss, although late-onset hearing loss has not been seen. Therefore, the follow-up ABR previously recommended at four to six months is no longer deemed necessary.
A comprehensive neurologic exam also is recommended. Seizures are sometimes part of Zika syndrome, but infants can also have subclinical EEG abnormalities. Advanced neuroimaging can identify obvious and subtle brain abnormalities, such as cortical thinning, corpus callosum abnormalities, calcifications at the junction of white and gray matter, and ventricular enlargement.
As infants grow, clinicians should be alert for signs of increased intracranial pressure that could signal postnatal hydrocephalus. Diaphragmatic paralysis also has been seen; it manifests as respiratory distress. Dysphagia that interferes with feeding can develop as well.
“The follow-up care of [these infants] requires a multidisciplinary team and an established medical home to facilitate the coordination of care and ensure that abnormal findings are addressed,” said Dr. Adebanjo and colleagues.
Asymptomatic Infants of Mothers With Possible Infection
Infants without clinical findings born to mothers with laboratory evidence of possible Zika virus infection during pregnancy should have the same early head ultrasound, hearing, and eye exams as those with clinical findings. All of these infants also should be tested for Zika virus just as those with clinical findings should be.
If tests are positive, these infants should have all the investigations and follow-up recommended for babies with clinical findings. If laboratory testing is negative, and clinical findings are normal, Zika infection is highly unlikely, and the infants can receive routine care. Clinicians and parents should be on the lookout, however, for new symptoms that might suggest postnatal Zika syndrome.
Asymptomatic Infants Whose Mothers Had Unconfirmed Zika Exposure
Infants without clinical findings consistent with congenital Zika syndrome born to mothers with possible Zika virus exposure in pregnancy, but without laboratory evidence of possible Zika virus infection during pregnancy, constitute a large group. Some women, for example, are never tested during pregnancy, and others have false negative test results. “Because the latter issues are not easily discerned, all mothers with possible exposure to Zika virus during pregnancy who do not have laboratory evidence of possible Zika virus infection, including those who tested negative with currently available technology, should be considered in this group,” said Dr. Adebanjo and colleagues.
The CDC do not recommend further Zika evaluation for these infants unless additional testing confirms maternal infection. For older infants, parents and clinicians should decide together whether further evaluations would be helpful. “If findings consistent with congenital Zika syndrome are identified at any time, referrals to the appropriate specialists should be made, and subsequent evaluation should follow recommendations for infants with clinical findings consistent with congenital Zika syndrome,” said the authors.
The CDC also reiterated their special recommendations for infants who had a prenatal diagnosis of Zika infection. For now, these recommendations remain unchanged, although “as more data become available, understanding of the diagnostic role of prenatal ultrasound and amniocentesis … will improve, and guidance will be updated.”
The optimal timing for a Zika diagnostic ultrasound is uncertain. The CDC recommend that serial ultrasounds be performed every three to four weeks for women with laboratory-confirmed prenatal Zika exposure. Women with possible exposure need only routine ultrasound screenings.
While Zika RNA has been identified in amniotic fluid, there is no consensus on the value of amniocentesis as a prenatal diagnostic tool. Investigations of serial amniocentesis suggest that viral shedding into the amniotic fluid might be transient. If amniocentesis is performed for other reasons, Zika nucleic acid testing can be incorporated.
A shared decision-making process about screening is key, said Dr. Adebanjo and colleagues. “For example, serial ultrasound examinations might be inconvenient, unpleasant, and expensive, and might prompt unnecessary interventions; amniocentesis carries additional known risks such as fetal loss. These potential harms of prenatal screening for congenital Zika syndrome might outweigh the clinical benefits for some patients; therefore, these decisions should be individualized.”
—Michele G. Sullivan
Suggested Reading
Adebanjo T, Godfred-Cato S, Viens L, et al. Update: Interim guidance for the diagnosis, evaluation, and management of infants with possible congenital Zika virus infection - United States, October 2017. MMWR Morb Mortal Wkly Rep. 2017;66(41):1089-1099.
Infants with possible prenatal exposure to Zika who test positive for the virus should receive an in-depth ophthalmologic exam, intensified hearing testing, and a thorough neurologic evaluation with brain imaging within one month of birth, according to new interim guidance from the Centers for Disease Control and Prevention (CDC).
The new clinical management guidelines, published in the October 20 issue of Morbidity and Mortality Weekly Report, supersede the CDC guidance issued in August 2016. The update was the product of a forum on the diagnosis, evaluation, and management of Zika in infants that the centers convened with the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists. Practicing clinicians and federal agency representatives reviewed the evolving body of knowledge on how best to care for these infants. Since Zika emerged as a public health concern, clinicians have reported postnatal onset of some symptoms, including eye abnormalities, incident microcephaly in infants with a normal head circumference at birth, EEG abnormalities, and diaphragmatic paralysis.
Infants With Clinical Findings Consistent With Zika Syndrome
Infants with clinical findings consistent with congenital Zika syndrome who are born to mothers with possible Zika virus exposure in pregnancy should be tested for Zika virus with serum and urine tests. If those tests are negative, and there is no other apparent cause of the symptoms, they should have a CSF sample tested for Zika RNA and IgM Zika antibodies.
By one month, these infants should undergo a head ultrasound and a detailed ophthalmologic exam. The eye exam should pick up any anomalies of the anterior and posterior eye, including microphthalmia, coloboma, intraocular calcifications, optic nerve hypoplasia and atrophy, and macular scarring with focal pigmentary retinal mottling.
By one month, these infants also should undergo auditory brainstem response (ABR) audiometry, especially if the initial newborn hearing screen was done by otoacoustic emissions alone. Zika syndrome can include sensorineural hearing loss, although late-onset hearing loss has not been seen. Therefore, the follow-up ABR previously recommended at four to six months is no longer deemed necessary.
A comprehensive neurologic exam also is recommended. Seizures are sometimes part of Zika syndrome, but infants can also have subclinical EEG abnormalities. Advanced neuroimaging can identify obvious and subtle brain abnormalities, such as cortical thinning, corpus callosum abnormalities, calcifications at the junction of white and gray matter, and ventricular enlargement.
As infants grow, clinicians should be alert for signs of increased intracranial pressure that could signal postnatal hydrocephalus. Diaphragmatic paralysis also has been seen; it manifests as respiratory distress. Dysphagia that interferes with feeding can develop as well.
“The follow-up care of [these infants] requires a multidisciplinary team and an established medical home to facilitate the coordination of care and ensure that abnormal findings are addressed,” said Dr. Adebanjo and colleagues.
Asymptomatic Infants of Mothers With Possible Infection
Infants without clinical findings born to mothers with laboratory evidence of possible Zika virus infection during pregnancy should have the same early head ultrasound, hearing, and eye exams as those with clinical findings. All of these infants also should be tested for Zika virus just as those with clinical findings should be.
If tests are positive, these infants should have all the investigations and follow-up recommended for babies with clinical findings. If laboratory testing is negative, and clinical findings are normal, Zika infection is highly unlikely, and the infants can receive routine care. Clinicians and parents should be on the lookout, however, for new symptoms that might suggest postnatal Zika syndrome.
Asymptomatic Infants Whose Mothers Had Unconfirmed Zika Exposure
Infants without clinical findings consistent with congenital Zika syndrome born to mothers with possible Zika virus exposure in pregnancy, but without laboratory evidence of possible Zika virus infection during pregnancy, constitute a large group. Some women, for example, are never tested during pregnancy, and others have false negative test results. “Because the latter issues are not easily discerned, all mothers with possible exposure to Zika virus during pregnancy who do not have laboratory evidence of possible Zika virus infection, including those who tested negative with currently available technology, should be considered in this group,” said Dr. Adebanjo and colleagues.
The CDC do not recommend further Zika evaluation for these infants unless additional testing confirms maternal infection. For older infants, parents and clinicians should decide together whether further evaluations would be helpful. “If findings consistent with congenital Zika syndrome are identified at any time, referrals to the appropriate specialists should be made, and subsequent evaluation should follow recommendations for infants with clinical findings consistent with congenital Zika syndrome,” said the authors.
The CDC also reiterated their special recommendations for infants who had a prenatal diagnosis of Zika infection. For now, these recommendations remain unchanged, although “as more data become available, understanding of the diagnostic role of prenatal ultrasound and amniocentesis … will improve, and guidance will be updated.”
The optimal timing for a Zika diagnostic ultrasound is uncertain. The CDC recommend that serial ultrasounds be performed every three to four weeks for women with laboratory-confirmed prenatal Zika exposure. Women with possible exposure need only routine ultrasound screenings.
While Zika RNA has been identified in amniotic fluid, there is no consensus on the value of amniocentesis as a prenatal diagnostic tool. Investigations of serial amniocentesis suggest that viral shedding into the amniotic fluid might be transient. If amniocentesis is performed for other reasons, Zika nucleic acid testing can be incorporated.
A shared decision-making process about screening is key, said Dr. Adebanjo and colleagues. “For example, serial ultrasound examinations might be inconvenient, unpleasant, and expensive, and might prompt unnecessary interventions; amniocentesis carries additional known risks such as fetal loss. These potential harms of prenatal screening for congenital Zika syndrome might outweigh the clinical benefits for some patients; therefore, these decisions should be individualized.”
—Michele G. Sullivan
Suggested Reading
Adebanjo T, Godfred-Cato S, Viens L, et al. Update: Interim guidance for the diagnosis, evaluation, and management of infants with possible congenital Zika virus infection - United States, October 2017. MMWR Morb Mortal Wkly Rep. 2017;66(41):1089-1099.
Infants with possible prenatal exposure to Zika who test positive for the virus should receive an in-depth ophthalmologic exam, intensified hearing testing, and a thorough neurologic evaluation with brain imaging within one month of birth, according to new interim guidance from the Centers for Disease Control and Prevention (CDC).
The new clinical management guidelines, published in the October 20 issue of Morbidity and Mortality Weekly Report, supersede the CDC guidance issued in August 2016. The update was the product of a forum on the diagnosis, evaluation, and management of Zika in infants that the centers convened with the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists. Practicing clinicians and federal agency representatives reviewed the evolving body of knowledge on how best to care for these infants. Since Zika emerged as a public health concern, clinicians have reported postnatal onset of some symptoms, including eye abnormalities, incident microcephaly in infants with a normal head circumference at birth, EEG abnormalities, and diaphragmatic paralysis.
Infants With Clinical Findings Consistent With Zika Syndrome
Infants with clinical findings consistent with congenital Zika syndrome who are born to mothers with possible Zika virus exposure in pregnancy should be tested for Zika virus with serum and urine tests. If those tests are negative, and there is no other apparent cause of the symptoms, they should have a CSF sample tested for Zika RNA and IgM Zika antibodies.
By one month, these infants should undergo a head ultrasound and a detailed ophthalmologic exam. The eye exam should pick up any anomalies of the anterior and posterior eye, including microphthalmia, coloboma, intraocular calcifications, optic nerve hypoplasia and atrophy, and macular scarring with focal pigmentary retinal mottling.
By one month, these infants also should undergo auditory brainstem response (ABR) audiometry, especially if the initial newborn hearing screen was done by otoacoustic emissions alone. Zika syndrome can include sensorineural hearing loss, although late-onset hearing loss has not been seen. Therefore, the follow-up ABR previously recommended at four to six months is no longer deemed necessary.
A comprehensive neurologic exam also is recommended. Seizures are sometimes part of Zika syndrome, but infants can also have subclinical EEG abnormalities. Advanced neuroimaging can identify obvious and subtle brain abnormalities, such as cortical thinning, corpus callosum abnormalities, calcifications at the junction of white and gray matter, and ventricular enlargement.
As infants grow, clinicians should be alert for signs of increased intracranial pressure that could signal postnatal hydrocephalus. Diaphragmatic paralysis also has been seen; it manifests as respiratory distress. Dysphagia that interferes with feeding can develop as well.
“The follow-up care of [these infants] requires a multidisciplinary team and an established medical home to facilitate the coordination of care and ensure that abnormal findings are addressed,” said Dr. Adebanjo and colleagues.
Asymptomatic Infants of Mothers With Possible Infection
Infants without clinical findings born to mothers with laboratory evidence of possible Zika virus infection during pregnancy should have the same early head ultrasound, hearing, and eye exams as those with clinical findings. All of these infants also should be tested for Zika virus just as those with clinical findings should be.
If tests are positive, these infants should have all the investigations and follow-up recommended for babies with clinical findings. If laboratory testing is negative, and clinical findings are normal, Zika infection is highly unlikely, and the infants can receive routine care. Clinicians and parents should be on the lookout, however, for new symptoms that might suggest postnatal Zika syndrome.
Asymptomatic Infants Whose Mothers Had Unconfirmed Zika Exposure
Infants without clinical findings consistent with congenital Zika syndrome born to mothers with possible Zika virus exposure in pregnancy, but without laboratory evidence of possible Zika virus infection during pregnancy, constitute a large group. Some women, for example, are never tested during pregnancy, and others have false negative test results. “Because the latter issues are not easily discerned, all mothers with possible exposure to Zika virus during pregnancy who do not have laboratory evidence of possible Zika virus infection, including those who tested negative with currently available technology, should be considered in this group,” said Dr. Adebanjo and colleagues.
The CDC do not recommend further Zika evaluation for these infants unless additional testing confirms maternal infection. For older infants, parents and clinicians should decide together whether further evaluations would be helpful. “If findings consistent with congenital Zika syndrome are identified at any time, referrals to the appropriate specialists should be made, and subsequent evaluation should follow recommendations for infants with clinical findings consistent with congenital Zika syndrome,” said the authors.
The CDC also reiterated their special recommendations for infants who had a prenatal diagnosis of Zika infection. For now, these recommendations remain unchanged, although “as more data become available, understanding of the diagnostic role of prenatal ultrasound and amniocentesis … will improve, and guidance will be updated.”
The optimal timing for a Zika diagnostic ultrasound is uncertain. The CDC recommend that serial ultrasounds be performed every three to four weeks for women with laboratory-confirmed prenatal Zika exposure. Women with possible exposure need only routine ultrasound screenings.
While Zika RNA has been identified in amniotic fluid, there is no consensus on the value of amniocentesis as a prenatal diagnostic tool. Investigations of serial amniocentesis suggest that viral shedding into the amniotic fluid might be transient. If amniocentesis is performed for other reasons, Zika nucleic acid testing can be incorporated.
A shared decision-making process about screening is key, said Dr. Adebanjo and colleagues. “For example, serial ultrasound examinations might be inconvenient, unpleasant, and expensive, and might prompt unnecessary interventions; amniocentesis carries additional known risks such as fetal loss. These potential harms of prenatal screening for congenital Zika syndrome might outweigh the clinical benefits for some patients; therefore, these decisions should be individualized.”
—Michele G. Sullivan
Suggested Reading
Adebanjo T, Godfred-Cato S, Viens L, et al. Update: Interim guidance for the diagnosis, evaluation, and management of infants with possible congenital Zika virus infection - United States, October 2017. MMWR Morb Mortal Wkly Rep. 2017;66(41):1089-1099.
Radiofrequency ablation improves stent patency in malignant biliary strictures
In patients with malignant biliary strictures, radiofrequency ablation may improve stent patency and prolong survival, according to results of a recent meta-analysis.
Radiofrequency ablation was also safe and well tolerated. The report appears in Gastrointestinal Endoscopy (2017. doi: 10.1016/j.gie.2017.10.029).
Although the data to date are limited and mostly observational, radiofrequency ablation “may be a promising adjuvant therapy in patients with malignant biliary obstruction who otherwise have dismal outcomes with current standard of therapy,” wrote Aijaz Ahmed Sofi, MD, of the department of gastroenterology, Arizona Center for Digestive Health, Gilbert, and coauthors.
Use of radiofrequency ablation is thought to improve the patency of biliary stents placed as a palliative measure in patients with unresectable malignant biliary strictures. However, several studies evaluating this and other endpoints have produced “variable results,” the authors said in the report.
In a comprehensive literature search, Dr. Sofi and colleagues identified nine studies including 505 patients. Only one of the studies was randomized and controlled, and results from it were preliminary, they noted.
Combined results showed a 50.6-day pooled weighted mean difference in stent patency (95% confidence interval, 32.83-68.48) in favor of radiofrequency ablation, according to reported data. In addition, there was a significant difference in survival favoring use of radiofrequency ablation (hazard ratio, 1.395; 95% confidence interval, 1.145-1.7; P less than .001).
While there was no difference between groups in risk of cholangitis, pancreatitis, hemobilia, and acute cholecystitis, abdominal pain after the procedure was more frequent in the radiofrequency ablation group (31% vs. 20%, P = .003).
This is the first systematic review and meta-analysis evaluating radiofrequency ablation as an adjuvant therapy in patients who receive biliary stents for malignant biliary obstruction, according to the investigators.
Despite the findings, Dr. Sofi and colleagues were careful to emphasize the limitations of the analysis, writing that it provides “very low quality evidence” in favor of radiofrequency ablation therapy for management of malignant biliary strictures.
“The results of currently ongoing controlled studies examining the role of RFA [radiofrequency ablation] in malignant biliary obstruction are keenly awaited,” they wrote.
Dr. Sofi and colleagues reported no potential conflicts of interest associated with the study.
In patients with malignant biliary strictures, radiofrequency ablation may improve stent patency and prolong survival, according to results of a recent meta-analysis.
Radiofrequency ablation was also safe and well tolerated. The report appears in Gastrointestinal Endoscopy (2017. doi: 10.1016/j.gie.2017.10.029).
Although the data to date are limited and mostly observational, radiofrequency ablation “may be a promising adjuvant therapy in patients with malignant biliary obstruction who otherwise have dismal outcomes with current standard of therapy,” wrote Aijaz Ahmed Sofi, MD, of the department of gastroenterology, Arizona Center for Digestive Health, Gilbert, and coauthors.
Use of radiofrequency ablation is thought to improve the patency of biliary stents placed as a palliative measure in patients with unresectable malignant biliary strictures. However, several studies evaluating this and other endpoints have produced “variable results,” the authors said in the report.
In a comprehensive literature search, Dr. Sofi and colleagues identified nine studies including 505 patients. Only one of the studies was randomized and controlled, and results from it were preliminary, they noted.
Combined results showed a 50.6-day pooled weighted mean difference in stent patency (95% confidence interval, 32.83-68.48) in favor of radiofrequency ablation, according to reported data. In addition, there was a significant difference in survival favoring use of radiofrequency ablation (hazard ratio, 1.395; 95% confidence interval, 1.145-1.7; P less than .001).
While there was no difference between groups in risk of cholangitis, pancreatitis, hemobilia, and acute cholecystitis, abdominal pain after the procedure was more frequent in the radiofrequency ablation group (31% vs. 20%, P = .003).
This is the first systematic review and meta-analysis evaluating radiofrequency ablation as an adjuvant therapy in patients who receive biliary stents for malignant biliary obstruction, according to the investigators.
Despite the findings, Dr. Sofi and colleagues were careful to emphasize the limitations of the analysis, writing that it provides “very low quality evidence” in favor of radiofrequency ablation therapy for management of malignant biliary strictures.
“The results of currently ongoing controlled studies examining the role of RFA [radiofrequency ablation] in malignant biliary obstruction are keenly awaited,” they wrote.
Dr. Sofi and colleagues reported no potential conflicts of interest associated with the study.
In patients with malignant biliary strictures, radiofrequency ablation may improve stent patency and prolong survival, according to results of a recent meta-analysis.
Radiofrequency ablation was also safe and well tolerated. The report appears in Gastrointestinal Endoscopy (2017. doi: 10.1016/j.gie.2017.10.029).
Although the data to date are limited and mostly observational, radiofrequency ablation “may be a promising adjuvant therapy in patients with malignant biliary obstruction who otherwise have dismal outcomes with current standard of therapy,” wrote Aijaz Ahmed Sofi, MD, of the department of gastroenterology, Arizona Center for Digestive Health, Gilbert, and coauthors.
Use of radiofrequency ablation is thought to improve the patency of biliary stents placed as a palliative measure in patients with unresectable malignant biliary strictures. However, several studies evaluating this and other endpoints have produced “variable results,” the authors said in the report.
In a comprehensive literature search, Dr. Sofi and colleagues identified nine studies including 505 patients. Only one of the studies was randomized and controlled, and results from it were preliminary, they noted.
Combined results showed a 50.6-day pooled weighted mean difference in stent patency (95% confidence interval, 32.83-68.48) in favor of radiofrequency ablation, according to reported data. In addition, there was a significant difference in survival favoring use of radiofrequency ablation (hazard ratio, 1.395; 95% confidence interval, 1.145-1.7; P less than .001).
While there was no difference between groups in risk of cholangitis, pancreatitis, hemobilia, and acute cholecystitis, abdominal pain after the procedure was more frequent in the radiofrequency ablation group (31% vs. 20%, P = .003).
This is the first systematic review and meta-analysis evaluating radiofrequency ablation as an adjuvant therapy in patients who receive biliary stents for malignant biliary obstruction, according to the investigators.
Despite the findings, Dr. Sofi and colleagues were careful to emphasize the limitations of the analysis, writing that it provides “very low quality evidence” in favor of radiofrequency ablation therapy for management of malignant biliary strictures.
“The results of currently ongoing controlled studies examining the role of RFA [radiofrequency ablation] in malignant biliary obstruction are keenly awaited,” they wrote.
Dr. Sofi and colleagues reported no potential conflicts of interest associated with the study.
FROM GASTROINTESTINAL ENDOSCOPY
Key clinical point: Although data to date are limited and mostly observational, radiofrequency ablation appears to improve stent patency and may prolong survival in patients with malignant biliary strictures.
Major finding: There was a significant difference in survival (P less than .001) and 50.6-day pooled weighted mean difference in stent patency (95% CI, 32.83-68.48) in favor of radiofrequency ablation.
Data source: A meta-analysis of 505 patients from nine studies that were identified through a comprehensive literature search.
Disclosures: There was no funding source for the study. The authors reported no potential conflicts of interest.
Observing BP measurement made no difference in SPRINT
ANAHEIM, CALIF. – More than half of the BP measurements of patients in the SPRINT trial were at least partially attended by clinic staff, but those efforts made no difference in outcomes, according to a survey presented by SPRINT investigators at the American Heart Association scientific sessions.
“It really didn’t matter” whether measurements were observed or not; blood pressure control and outcomes – fewer deaths and cardiovascular events when hypertension was treated to below 120 mm Hg instead of below 140 mm Hg – were largely the same either way, said the survey’s lead investigator Karen C. Johnson, MD, professor of women’s health and preventive medicine at the University of Tennessee in Memphis.
What did matter were the other measures SPRINT [Systolic Blood Pressure Intervention Trial] took to ensure accurate blood pressure measurement, including patients resting for 5 minutes; three automated readings taken afterward then averaged; proper cuff size; feet flat on the floor while patients sat; arms at proper level, and no talking, texting, or filling out forms during the reading, Dr. Johnson said (N Engl J Med. 2015 Nov 26;373[22]:2103-16).
“If you do [those things], then it doesn’t matter if somebody is in the room or not; you can treat to the levels we are talking about,” said William Cushman, MD, professor of medicine and physiology at the university, and also a SPRINT investigator.
Although the SPRINT researchers hadn’t addressed the issue before the AHA meeting, it’s been widely thought, and even reported in some places, that blood pressures in the trial were unattended. The misperception has led to anxiety about how to apply SPRINT to everyday practice, since few clinics are set up to have patients sit alone for 5 or 10 minutes for a blood pressure.
To address the concern, the SPRINT team surveyed study sites after the trial ended. It turned out that 4,082 subjects were at sites where patients were usually left alone for both the 5-minute rest period and the three BP readings, and 2,247 were at sites where staff usually attended both; 1,746 were at sites that left patients alone for the rest period only; and 570 were at sites where patients were alone only for the BP readings.
Observation had no impact on blood pressure. In the intensive arm, participants achieved and maintained an average systolic BP of about 120 mm Hg in all four groups. In the standard treatment arm, that average was about 135 mm Hg in all four groups. “When we look at the number of medications used, they were very similar in all four blood pressure groups,” with intensive treatment patients taking an average of one extra drug, Dr. Johnson said.
Intensive treatment, versus standard treatment, reduced cardiovascular events to a similar extent in patients who were alone for the entire blood pressure reading (by 38%) and those who were accompanied throughout (by 36%). For reasons that are not clear, intensive treatment did not significantly reduce risk among subjects who were observed during rest or observed for blood pressure readings. Both groups had lower Framingham 10-year cardiovascular disease risk scores, which may have been a confounder.
Meanwhile, the rate of adverse events and total mortality – lower with intensive treatment – did not vary by observation, Dr. Johnson said.
The survey excluded 716 subjects at 14 study sites who could not be classified into one of the four BP observation categories.
SPRINT was sponsored by the National Institutes of Health. Doctors Johnson and Cushman didn’t have any disclosures.
ANAHEIM, CALIF. – More than half of the BP measurements of patients in the SPRINT trial were at least partially attended by clinic staff, but those efforts made no difference in outcomes, according to a survey presented by SPRINT investigators at the American Heart Association scientific sessions.
“It really didn’t matter” whether measurements were observed or not; blood pressure control and outcomes – fewer deaths and cardiovascular events when hypertension was treated to below 120 mm Hg instead of below 140 mm Hg – were largely the same either way, said the survey’s lead investigator Karen C. Johnson, MD, professor of women’s health and preventive medicine at the University of Tennessee in Memphis.
What did matter were the other measures SPRINT [Systolic Blood Pressure Intervention Trial] took to ensure accurate blood pressure measurement, including patients resting for 5 minutes; three automated readings taken afterward then averaged; proper cuff size; feet flat on the floor while patients sat; arms at proper level, and no talking, texting, or filling out forms during the reading, Dr. Johnson said (N Engl J Med. 2015 Nov 26;373[22]:2103-16).
“If you do [those things], then it doesn’t matter if somebody is in the room or not; you can treat to the levels we are talking about,” said William Cushman, MD, professor of medicine and physiology at the university, and also a SPRINT investigator.
Although the SPRINT researchers hadn’t addressed the issue before the AHA meeting, it’s been widely thought, and even reported in some places, that blood pressures in the trial were unattended. The misperception has led to anxiety about how to apply SPRINT to everyday practice, since few clinics are set up to have patients sit alone for 5 or 10 minutes for a blood pressure.
To address the concern, the SPRINT team surveyed study sites after the trial ended. It turned out that 4,082 subjects were at sites where patients were usually left alone for both the 5-minute rest period and the three BP readings, and 2,247 were at sites where staff usually attended both; 1,746 were at sites that left patients alone for the rest period only; and 570 were at sites where patients were alone only for the BP readings.
Observation had no impact on blood pressure. In the intensive arm, participants achieved and maintained an average systolic BP of about 120 mm Hg in all four groups. In the standard treatment arm, that average was about 135 mm Hg in all four groups. “When we look at the number of medications used, they were very similar in all four blood pressure groups,” with intensive treatment patients taking an average of one extra drug, Dr. Johnson said.
Intensive treatment, versus standard treatment, reduced cardiovascular events to a similar extent in patients who were alone for the entire blood pressure reading (by 38%) and those who were accompanied throughout (by 36%). For reasons that are not clear, intensive treatment did not significantly reduce risk among subjects who were observed during rest or observed for blood pressure readings. Both groups had lower Framingham 10-year cardiovascular disease risk scores, which may have been a confounder.
Meanwhile, the rate of adverse events and total mortality – lower with intensive treatment – did not vary by observation, Dr. Johnson said.
The survey excluded 716 subjects at 14 study sites who could not be classified into one of the four BP observation categories.
SPRINT was sponsored by the National Institutes of Health. Doctors Johnson and Cushman didn’t have any disclosures.
ANAHEIM, CALIF. – More than half of the BP measurements of patients in the SPRINT trial were at least partially attended by clinic staff, but those efforts made no difference in outcomes, according to a survey presented by SPRINT investigators at the American Heart Association scientific sessions.
“It really didn’t matter” whether measurements were observed or not; blood pressure control and outcomes – fewer deaths and cardiovascular events when hypertension was treated to below 120 mm Hg instead of below 140 mm Hg – were largely the same either way, said the survey’s lead investigator Karen C. Johnson, MD, professor of women’s health and preventive medicine at the University of Tennessee in Memphis.
What did matter were the other measures SPRINT [Systolic Blood Pressure Intervention Trial] took to ensure accurate blood pressure measurement, including patients resting for 5 minutes; three automated readings taken afterward then averaged; proper cuff size; feet flat on the floor while patients sat; arms at proper level, and no talking, texting, or filling out forms during the reading, Dr. Johnson said (N Engl J Med. 2015 Nov 26;373[22]:2103-16).
“If you do [those things], then it doesn’t matter if somebody is in the room or not; you can treat to the levels we are talking about,” said William Cushman, MD, professor of medicine and physiology at the university, and also a SPRINT investigator.
Although the SPRINT researchers hadn’t addressed the issue before the AHA meeting, it’s been widely thought, and even reported in some places, that blood pressures in the trial were unattended. The misperception has led to anxiety about how to apply SPRINT to everyday practice, since few clinics are set up to have patients sit alone for 5 or 10 minutes for a blood pressure.
To address the concern, the SPRINT team surveyed study sites after the trial ended. It turned out that 4,082 subjects were at sites where patients were usually left alone for both the 5-minute rest period and the three BP readings, and 2,247 were at sites where staff usually attended both; 1,746 were at sites that left patients alone for the rest period only; and 570 were at sites where patients were alone only for the BP readings.
Observation had no impact on blood pressure. In the intensive arm, participants achieved and maintained an average systolic BP of about 120 mm Hg in all four groups. In the standard treatment arm, that average was about 135 mm Hg in all four groups. “When we look at the number of medications used, they were very similar in all four blood pressure groups,” with intensive treatment patients taking an average of one extra drug, Dr. Johnson said.
Intensive treatment, versus standard treatment, reduced cardiovascular events to a similar extent in patients who were alone for the entire blood pressure reading (by 38%) and those who were accompanied throughout (by 36%). For reasons that are not clear, intensive treatment did not significantly reduce risk among subjects who were observed during rest or observed for blood pressure readings. Both groups had lower Framingham 10-year cardiovascular disease risk scores, which may have been a confounder.
Meanwhile, the rate of adverse events and total mortality – lower with intensive treatment – did not vary by observation, Dr. Johnson said.
The survey excluded 716 subjects at 14 study sites who could not be classified into one of the four BP observation categories.
SPRINT was sponsored by the National Institutes of Health. Doctors Johnson and Cushman didn’t have any disclosures.
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: Blood pressure and CV event reductions were similar in the 4,082 subjects at sites where patients were usually left alone for both the 5-minute rest period and the three BP readings, the 2,247 patients at sites where staff usually attended both, the 1,746 at sites that left patients alone for the rest period only, and the 570 at sites where patients were alone only for the BP readings.
Data source: A survey of SPRINT study sites.
Disclosures: SPRINT was sponsored by the National Institutes of Health. The presenter had no disclosures.
Intepirdine flops in phase 3 study of mild to moderate Alzheimer’s patients
BOSTON – An investigational Alzheimer’s drug intended to potentiate acetylcholine release didn’t pass muster in a global phase 3 study, despite a successful phase 2 trial.
Intepirdine on a background of stable-dose donepezil failed to confer any cognitive or functional benefit in patients with mild to moderate Alzheimer’s disease, Ilise Lombardo, PhD, said at the Clinical Trials on Alzheimer’s Disease conference.
Intepirdine blocks the 5-hydroxytryptamine receptor 6 and increases the release of acetylcholine, according to Dr. Lombardo. By giving it on a stable background of an acetylcholinesterase inhibitor, researchers hoped to improve cognition by increasing acetylcholine signaling between neurons. In a modestly successful phase 2b study reported out last summer, intepirdine did confer some cognitive and functional benefits.
The study was scheduled to be presented at the Alzheimer’s Association International Conference, but was pulled at the last minute when Axovant announced its initial public offering of stock shortly before the July meeting. However, Dr. Lombardo did review study 866 at CTAD. It randomized 269 patients with mild to moderate AD to placebo or intepirdine at 15 mg or 35 mg/day for 24 weeks. By 12 weeks, patients taking the 35-mg dose had declined 1.6 points less than those on placebo on the Alzheimer’s Disease Assessment Scale–cognitive subscale (ADAS-cog) and 1.94 points on the Alzheimer’s Disease Cooperative Study–Activities of Daily Living (ADCS-ADL). Both differences were statistically significant. The drug moved into a phase 3 study, dubbed MINDSET, at 35 mg.
MINDSET enrolled 1, 315 patients with mild to moderate Alzheimer’s disease and randomized them to placebo or 35 mg intepirdine for 24 weeks. All patients were on stable background donepezil. Again, the coprimary endpoints were the ADAS-cog and the ADCS-ADL at the end of the study. There were three secondary endpoints: the Clinician Interview-Based Impression of Change plus caregiver interview (CIBIC+), the Dependence Scale, and the Neuropsychiatric Inventory.
Patients were a mean of 70 years old with a mean Mini-Mental State Exam (MMSE) score of 18.5. The mean ADAS-cog score was 24 and the mean ADCS-ADL score, 58.
On the ADAS-cog, both groups exhibited a positive placebo response in the first 6 weeks, followed by a mean decline of 0.36 points. There was no statistically significant between-group difference. The story was much the same on the ADCS-ADL measure. Both groups had a brief placebo response, followed by a mean decline of 1.06 points. Again, the intepirdine and placebo groups declined similarly. There were no significant differences on either measure when the groups were broken down into patients with mild and moderate disease.
The CIBIC+ score was the only positive response among the secondary endpoints. Compared with those taking placebo, those taking intepirdine were more likely to be rated as minimally improved or unchanged.
The drug was safe however, with virtually no between-group difference in the occurrence of or the type of serious adverse events (about 6% in each group). Five patents died during the study; none of the deaths were related to the study drug.
Although Axovant no longer lists intepirdine as a potential Alzheimer’s treatment, investigation continues in a phase 3 placebo-controlled study in patients with Lewy body dementia. HEADWAY is testing a 70-mg dose, Dr. Lombardo said.
“Enrollment is finished and we are looking forward to results,” in early 2018. Answering a question about why the company went with 35 mg instead of 70 mg in MINDSET, she said that Axovant wanted to recreate the success of study 866.
“Since we had statistical significance even at 12 weeks with 35 mg, that’s what we went with,” she said. However, reviewing the adverse events told investigators that “we were not even near the maximum tolerated dose” at 35 mg. “Certainly we are now faced with the question of whether there will be a better response with 70 mg, and we are looking forward to answering that question with HEADWAY.”
Dr. Lombardo is senior vice president for clinical research at Axovant Sciences.
msullivan@frontlinemedcom.com
On Twitter @alz_gal
BOSTON – An investigational Alzheimer’s drug intended to potentiate acetylcholine release didn’t pass muster in a global phase 3 study, despite a successful phase 2 trial.
Intepirdine on a background of stable-dose donepezil failed to confer any cognitive or functional benefit in patients with mild to moderate Alzheimer’s disease, Ilise Lombardo, PhD, said at the Clinical Trials on Alzheimer’s Disease conference.
Intepirdine blocks the 5-hydroxytryptamine receptor 6 and increases the release of acetylcholine, according to Dr. Lombardo. By giving it on a stable background of an acetylcholinesterase inhibitor, researchers hoped to improve cognition by increasing acetylcholine signaling between neurons. In a modestly successful phase 2b study reported out last summer, intepirdine did confer some cognitive and functional benefits.
The study was scheduled to be presented at the Alzheimer’s Association International Conference, but was pulled at the last minute when Axovant announced its initial public offering of stock shortly before the July meeting. However, Dr. Lombardo did review study 866 at CTAD. It randomized 269 patients with mild to moderate AD to placebo or intepirdine at 15 mg or 35 mg/day for 24 weeks. By 12 weeks, patients taking the 35-mg dose had declined 1.6 points less than those on placebo on the Alzheimer’s Disease Assessment Scale–cognitive subscale (ADAS-cog) and 1.94 points on the Alzheimer’s Disease Cooperative Study–Activities of Daily Living (ADCS-ADL). Both differences were statistically significant. The drug moved into a phase 3 study, dubbed MINDSET, at 35 mg.
MINDSET enrolled 1, 315 patients with mild to moderate Alzheimer’s disease and randomized them to placebo or 35 mg intepirdine for 24 weeks. All patients were on stable background donepezil. Again, the coprimary endpoints were the ADAS-cog and the ADCS-ADL at the end of the study. There were three secondary endpoints: the Clinician Interview-Based Impression of Change plus caregiver interview (CIBIC+), the Dependence Scale, and the Neuropsychiatric Inventory.
Patients were a mean of 70 years old with a mean Mini-Mental State Exam (MMSE) score of 18.5. The mean ADAS-cog score was 24 and the mean ADCS-ADL score, 58.
On the ADAS-cog, both groups exhibited a positive placebo response in the first 6 weeks, followed by a mean decline of 0.36 points. There was no statistically significant between-group difference. The story was much the same on the ADCS-ADL measure. Both groups had a brief placebo response, followed by a mean decline of 1.06 points. Again, the intepirdine and placebo groups declined similarly. There were no significant differences on either measure when the groups were broken down into patients with mild and moderate disease.
The CIBIC+ score was the only positive response among the secondary endpoints. Compared with those taking placebo, those taking intepirdine were more likely to be rated as minimally improved or unchanged.
The drug was safe however, with virtually no between-group difference in the occurrence of or the type of serious adverse events (about 6% in each group). Five patents died during the study; none of the deaths were related to the study drug.
Although Axovant no longer lists intepirdine as a potential Alzheimer’s treatment, investigation continues in a phase 3 placebo-controlled study in patients with Lewy body dementia. HEADWAY is testing a 70-mg dose, Dr. Lombardo said.
“Enrollment is finished and we are looking forward to results,” in early 2018. Answering a question about why the company went with 35 mg instead of 70 mg in MINDSET, she said that Axovant wanted to recreate the success of study 866.
“Since we had statistical significance even at 12 weeks with 35 mg, that’s what we went with,” she said. However, reviewing the adverse events told investigators that “we were not even near the maximum tolerated dose” at 35 mg. “Certainly we are now faced with the question of whether there will be a better response with 70 mg, and we are looking forward to answering that question with HEADWAY.”
Dr. Lombardo is senior vice president for clinical research at Axovant Sciences.
msullivan@frontlinemedcom.com
On Twitter @alz_gal
BOSTON – An investigational Alzheimer’s drug intended to potentiate acetylcholine release didn’t pass muster in a global phase 3 study, despite a successful phase 2 trial.
Intepirdine on a background of stable-dose donepezil failed to confer any cognitive or functional benefit in patients with mild to moderate Alzheimer’s disease, Ilise Lombardo, PhD, said at the Clinical Trials on Alzheimer’s Disease conference.
Intepirdine blocks the 5-hydroxytryptamine receptor 6 and increases the release of acetylcholine, according to Dr. Lombardo. By giving it on a stable background of an acetylcholinesterase inhibitor, researchers hoped to improve cognition by increasing acetylcholine signaling between neurons. In a modestly successful phase 2b study reported out last summer, intepirdine did confer some cognitive and functional benefits.
The study was scheduled to be presented at the Alzheimer’s Association International Conference, but was pulled at the last minute when Axovant announced its initial public offering of stock shortly before the July meeting. However, Dr. Lombardo did review study 866 at CTAD. It randomized 269 patients with mild to moderate AD to placebo or intepirdine at 15 mg or 35 mg/day for 24 weeks. By 12 weeks, patients taking the 35-mg dose had declined 1.6 points less than those on placebo on the Alzheimer’s Disease Assessment Scale–cognitive subscale (ADAS-cog) and 1.94 points on the Alzheimer’s Disease Cooperative Study–Activities of Daily Living (ADCS-ADL). Both differences were statistically significant. The drug moved into a phase 3 study, dubbed MINDSET, at 35 mg.
MINDSET enrolled 1, 315 patients with mild to moderate Alzheimer’s disease and randomized them to placebo or 35 mg intepirdine for 24 weeks. All patients were on stable background donepezil. Again, the coprimary endpoints were the ADAS-cog and the ADCS-ADL at the end of the study. There were three secondary endpoints: the Clinician Interview-Based Impression of Change plus caregiver interview (CIBIC+), the Dependence Scale, and the Neuropsychiatric Inventory.
Patients were a mean of 70 years old with a mean Mini-Mental State Exam (MMSE) score of 18.5. The mean ADAS-cog score was 24 and the mean ADCS-ADL score, 58.
On the ADAS-cog, both groups exhibited a positive placebo response in the first 6 weeks, followed by a mean decline of 0.36 points. There was no statistically significant between-group difference. The story was much the same on the ADCS-ADL measure. Both groups had a brief placebo response, followed by a mean decline of 1.06 points. Again, the intepirdine and placebo groups declined similarly. There were no significant differences on either measure when the groups were broken down into patients with mild and moderate disease.
The CIBIC+ score was the only positive response among the secondary endpoints. Compared with those taking placebo, those taking intepirdine were more likely to be rated as minimally improved or unchanged.
The drug was safe however, with virtually no between-group difference in the occurrence of or the type of serious adverse events (about 6% in each group). Five patents died during the study; none of the deaths were related to the study drug.
Although Axovant no longer lists intepirdine as a potential Alzheimer’s treatment, investigation continues in a phase 3 placebo-controlled study in patients with Lewy body dementia. HEADWAY is testing a 70-mg dose, Dr. Lombardo said.
“Enrollment is finished and we are looking forward to results,” in early 2018. Answering a question about why the company went with 35 mg instead of 70 mg in MINDSET, she said that Axovant wanted to recreate the success of study 866.
“Since we had statistical significance even at 12 weeks with 35 mg, that’s what we went with,” she said. However, reviewing the adverse events told investigators that “we were not even near the maximum tolerated dose” at 35 mg. “Certainly we are now faced with the question of whether there will be a better response with 70 mg, and we are looking forward to answering that question with HEADWAY.”
Dr. Lombardo is senior vice president for clinical research at Axovant Sciences.
msullivan@frontlinemedcom.com
On Twitter @alz_gal
AT CTAD
Key clinical point:
Major finding: On the ADAS-cog at 24 weeks, there was a mean decline of 0.36 points; on the ADCS-ADL, the mean decline was 1.06 points. There were no between-group differences, either overall or in the mild to moderate groups separately.
Data source: The placebo-controlled study randomized 1,315 patients to placebo or 35 mg daily intepirdine.
Disclosures: Dr. Lombardo is senior vice president for clinical research at Axovant Sciences, which is developing the drug.