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Don’t trust interface dermatitis to diagnose dermatomyositis
ORLANDO – (DM), according to David Fiorentino, MD, PhD, professor of dermatology, rheumatology, and immunology at Stanford (Calif.) University.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Interface dermatitis on skin biopsy is “felt to be almost required by many people to make the diagnosis,” but he and his associates found that it was not present in about a quarter of a cohort of patients with DM. “We don’t want a clinician” to rule out the diagnosis based on its absence on a biopsy, “when its actually quite possible that the patient could have disease,” Dr. Fiorentino said at the International Conference on Cutaneous Lupus Erythematosus.
In general, skin biopsies in DM are tricky. “All of us take them, but we don’t really know how to interpret the information that comes back ... because we don’t really know how often many of [the associated] findings are seen” in DM patients, he noted.
One of the main concerns is to rule out lupus, but interface dermatitis is found in many of its cutaneous forms, as well as in graft-versus-host disease and other diseases.
So what’s a clinician to do? Fortunately, direct immunofluorescence can help. A positive lupus band test helps rule out DM, and the membrane attack complex helps rule it in, both with a good degree of certainty. In a video interview, Dr. Fiorentino explained these tests and how to use them.
Dr. Fiorentino had no relevant disclosures.
aotto@mdedge.com
ORLANDO – (DM), according to David Fiorentino, MD, PhD, professor of dermatology, rheumatology, and immunology at Stanford (Calif.) University.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Interface dermatitis on skin biopsy is “felt to be almost required by many people to make the diagnosis,” but he and his associates found that it was not present in about a quarter of a cohort of patients with DM. “We don’t want a clinician” to rule out the diagnosis based on its absence on a biopsy, “when its actually quite possible that the patient could have disease,” Dr. Fiorentino said at the International Conference on Cutaneous Lupus Erythematosus.
In general, skin biopsies in DM are tricky. “All of us take them, but we don’t really know how to interpret the information that comes back ... because we don’t really know how often many of [the associated] findings are seen” in DM patients, he noted.
One of the main concerns is to rule out lupus, but interface dermatitis is found in many of its cutaneous forms, as well as in graft-versus-host disease and other diseases.
So what’s a clinician to do? Fortunately, direct immunofluorescence can help. A positive lupus band test helps rule out DM, and the membrane attack complex helps rule it in, both with a good degree of certainty. In a video interview, Dr. Fiorentino explained these tests and how to use them.
Dr. Fiorentino had no relevant disclosures.
aotto@mdedge.com
ORLANDO – (DM), according to David Fiorentino, MD, PhD, professor of dermatology, rheumatology, and immunology at Stanford (Calif.) University.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Interface dermatitis on skin biopsy is “felt to be almost required by many people to make the diagnosis,” but he and his associates found that it was not present in about a quarter of a cohort of patients with DM. “We don’t want a clinician” to rule out the diagnosis based on its absence on a biopsy, “when its actually quite possible that the patient could have disease,” Dr. Fiorentino said at the International Conference on Cutaneous Lupus Erythematosus.
In general, skin biopsies in DM are tricky. “All of us take them, but we don’t really know how to interpret the information that comes back ... because we don’t really know how often many of [the associated] findings are seen” in DM patients, he noted.
One of the main concerns is to rule out lupus, but interface dermatitis is found in many of its cutaneous forms, as well as in graft-versus-host disease and other diseases.
So what’s a clinician to do? Fortunately, direct immunofluorescence can help. A positive lupus band test helps rule out DM, and the membrane attack complex helps rule it in, both with a good degree of certainty. In a video interview, Dr. Fiorentino explained these tests and how to use them.
Dr. Fiorentino had no relevant disclosures.
aotto@mdedge.com
REPORTING FROM ICCLE 2018
Antibiotic stewardship in sepsis
ORLANDO – When is it rational to consider de-escalating, or even stopping, antibiotics for septic patients, and how will patients’ future health be affected by antibiotic use during critical illnesses?
According to Jennifer Hanrahan, DO, of Case Western Reserve University, Cleveland, locating the tipping point between optimal care for the individual patient in sepsis, and the importance of antibiotic stewardship is a balancing act. It’s a process guided by laboratory findings, by knowledge of local pathogens and patterns of antimicrobial resistance, and also by clinical judgment, she said at the annual meeting of the Society of Hospital Medicine.
By all means, begin antibiotics for patients with sepsis, Dr. Hanrahan, also medical director of infection prevention at MetroHealth Medical Center, Cleveland, told attendees at a pre-course at HM18. “Prompt initiation of antibiotics for sepsis is critical, and appropriate use of antibiotics decreases mortality.” However, she noted, de-escalation of antibiotics also decreases mortality.
“What is antibiotic stewardship? Most of us think of this as the microbial stewardship police calling to ask you, ‘Why are you using this antibiotic?’’ she said. “It’s really the right antibiotic, for the right diagnosis, for the appropriate duration.”
Of course, Dr. Hanrahan said, any medication is associated with potential adverse events, and antibiotics are no different. “Almost one-third of antibiotics given are either unnecessary or inappropriate,” she said.
Antimicrobial resistance is a very serious public health threat, Dr. Hanrahan affirmed. “Antibiotic use is the most important modifiable factor related to development of antibiotic resistance. With regard to multidrug resistant [MDR] gram negatives, we are running out of antibiotics” to treat these organisms, she said, noting that “Many antibiotics to treat MDRs are “astronomically expensive – and that’s a really big problem.”
It’s important to remember that, when antibiotics are prescribed, “You’re affecting the microbiome not just of that patient, but of those around them,” as resistance factors are potentially spread from one individual’s microbiome to their friends, family, and other contacts, Dr. Hanrahan said.
The later risk of sepsis has also shown to be elevated for individuals who have received high-risk antibiotics such as fluoroquinolones, third- and fourth-generation cephalosporins, beta-lactamase inhibitor formulations, vancomycin, and carbapenems – many of which are also used to treat sepsis. All of these antibiotics kill anaerobic bacteria, Dr. Hanrahan said, and “when you kill anaerobes you do a lot of bad things to people.”
Identifying the pathogens
There are already many frightening players in the antibiotic-resistant landscape. Among them are carbapenem-resistant Enterobacteriaceae, increasingly common in health care settings. Unfortunately, with methicillin-resistant Staphylococcus aureus (MRSA), “we’ve lost the battle,” Dr. Hanrahan said.
Acinetobacter is another increasing threat, she said, as is Candida auris, which has caused large outbreaks in Europe. Because it’s resistant to azole antifungals, once C. auris comes to U.S. hospitals, “You’re going to have a really big problem,” she said. Finally, multidrug resistant and extremely drug resistant Pseudomonas species are being encountered with increasing frequency.
And, of course, Clostridium difficile infections continue to ravage older populations. “One in 11 people aged 65 or older will die from C. diff infections,” said Dr. Hanrahan.
For all of these bacteria, she said, “I can’t tell you what antibiotics to use because you have to know what the organisms are in your hospital.” A good resource for tracking local resistance patterns is the information provided by the Centers for Disease Control and Prevention, including interactive maps showing health care–associated infections, as well as HealthMap ResistanceOpen, which maps antibiotic resistance alerts across the United States. The CDC also offers training on antibiotic stewardship; Dr. Hanrahan said the several hours she spent completing the training were well spent.
After a broad-spectrum antibiotic is initiated for sepsis, Dr. Hanrahan said that the next infectious disease–related steps should focus on identifying pathogens so antimicrobial therapy can be tailored or scaled back appropriately. In many cases, this will mean obtaining blood cultures – ideally, two sets from two separate sites. It’s no longer thought necessary to separate the blood draws by 20 minutes, or to try to time the draw during a febrile episode, she said.
What is important is to make sure that you’re not treating contamination or colonization – “Treat only clinically significant infections,” Dr. Hanrahan said. A common red herring, especially among elderly individuals coming from assisted living or in patients with indwelling urinary catheters, is a positive urine culture in the absence of signs or symptoms of urinary tract infection. Think twice about whether this truly represents a source of infection, she said. “Don’t treat asymptomatic bacteriuria.”
In order to avoid “chasing contamination,” do not obtain the blood culture samples from a venipuncture site. “Contamination is twice as likely when drawing from a venipuncture site,” Dr. Hanrahan noted. “When possible you should avoid this.”
It’s also important to remember that 10% of fever in hospitalized individuals is from a noninfectious source. “Take a careful history, and do a physical exam to help distinguish infections from other causes of fever,” said Dr. Hanrahan.
Additional investigations to consider in highly immunocompromised patients might include both mycobacterial and fungal cultures, although these studies are otherwise generally low yield. And, she said, “Don’t send catheter-tip cultures – it’s pointless, and it really doesn’t add much information.”
Good clinical judgment still goes a long way toward guiding therapy. “If a patient is stable and it’s not clear whether an antibiotic is needed, consider waiting and re-evaluating later,” Dr. Hanrahan said.
Generally, duration of treatment should also be clinically based. “Stop antibiotics as soon as possible, and remove catheters as soon as possible,” Dr. Hanrahan said, adding that few infections really warrant treatment for a fixed amount of time. These include meningitis, endocarditis, tuberculosis, and many cases of osteomyelitis.
Similarly, when a patient who had been ill now looks well, feels well, and is stable or improving, there’s usually no need for repeat blood cultures, Dr. Hanrahan said. Still, a cautious balance is where most clinicians will wind up.
“I learned a long time ago that I have to do the things that let me go home and sleep at night,” she concluded.
Dr. Hanrahan reported having been a consultant for Gilead, Astellas, and Cempra.
ORLANDO – When is it rational to consider de-escalating, or even stopping, antibiotics for septic patients, and how will patients’ future health be affected by antibiotic use during critical illnesses?
According to Jennifer Hanrahan, DO, of Case Western Reserve University, Cleveland, locating the tipping point between optimal care for the individual patient in sepsis, and the importance of antibiotic stewardship is a balancing act. It’s a process guided by laboratory findings, by knowledge of local pathogens and patterns of antimicrobial resistance, and also by clinical judgment, she said at the annual meeting of the Society of Hospital Medicine.
By all means, begin antibiotics for patients with sepsis, Dr. Hanrahan, also medical director of infection prevention at MetroHealth Medical Center, Cleveland, told attendees at a pre-course at HM18. “Prompt initiation of antibiotics for sepsis is critical, and appropriate use of antibiotics decreases mortality.” However, she noted, de-escalation of antibiotics also decreases mortality.
“What is antibiotic stewardship? Most of us think of this as the microbial stewardship police calling to ask you, ‘Why are you using this antibiotic?’’ she said. “It’s really the right antibiotic, for the right diagnosis, for the appropriate duration.”
Of course, Dr. Hanrahan said, any medication is associated with potential adverse events, and antibiotics are no different. “Almost one-third of antibiotics given are either unnecessary or inappropriate,” she said.
Antimicrobial resistance is a very serious public health threat, Dr. Hanrahan affirmed. “Antibiotic use is the most important modifiable factor related to development of antibiotic resistance. With regard to multidrug resistant [MDR] gram negatives, we are running out of antibiotics” to treat these organisms, she said, noting that “Many antibiotics to treat MDRs are “astronomically expensive – and that’s a really big problem.”
It’s important to remember that, when antibiotics are prescribed, “You’re affecting the microbiome not just of that patient, but of those around them,” as resistance factors are potentially spread from one individual’s microbiome to their friends, family, and other contacts, Dr. Hanrahan said.
The later risk of sepsis has also shown to be elevated for individuals who have received high-risk antibiotics such as fluoroquinolones, third- and fourth-generation cephalosporins, beta-lactamase inhibitor formulations, vancomycin, and carbapenems – many of which are also used to treat sepsis. All of these antibiotics kill anaerobic bacteria, Dr. Hanrahan said, and “when you kill anaerobes you do a lot of bad things to people.”
Identifying the pathogens
There are already many frightening players in the antibiotic-resistant landscape. Among them are carbapenem-resistant Enterobacteriaceae, increasingly common in health care settings. Unfortunately, with methicillin-resistant Staphylococcus aureus (MRSA), “we’ve lost the battle,” Dr. Hanrahan said.
Acinetobacter is another increasing threat, she said, as is Candida auris, which has caused large outbreaks in Europe. Because it’s resistant to azole antifungals, once C. auris comes to U.S. hospitals, “You’re going to have a really big problem,” she said. Finally, multidrug resistant and extremely drug resistant Pseudomonas species are being encountered with increasing frequency.
And, of course, Clostridium difficile infections continue to ravage older populations. “One in 11 people aged 65 or older will die from C. diff infections,” said Dr. Hanrahan.
For all of these bacteria, she said, “I can’t tell you what antibiotics to use because you have to know what the organisms are in your hospital.” A good resource for tracking local resistance patterns is the information provided by the Centers for Disease Control and Prevention, including interactive maps showing health care–associated infections, as well as HealthMap ResistanceOpen, which maps antibiotic resistance alerts across the United States. The CDC also offers training on antibiotic stewardship; Dr. Hanrahan said the several hours she spent completing the training were well spent.
After a broad-spectrum antibiotic is initiated for sepsis, Dr. Hanrahan said that the next infectious disease–related steps should focus on identifying pathogens so antimicrobial therapy can be tailored or scaled back appropriately. In many cases, this will mean obtaining blood cultures – ideally, two sets from two separate sites. It’s no longer thought necessary to separate the blood draws by 20 minutes, or to try to time the draw during a febrile episode, she said.
What is important is to make sure that you’re not treating contamination or colonization – “Treat only clinically significant infections,” Dr. Hanrahan said. A common red herring, especially among elderly individuals coming from assisted living or in patients with indwelling urinary catheters, is a positive urine culture in the absence of signs or symptoms of urinary tract infection. Think twice about whether this truly represents a source of infection, she said. “Don’t treat asymptomatic bacteriuria.”
In order to avoid “chasing contamination,” do not obtain the blood culture samples from a venipuncture site. “Contamination is twice as likely when drawing from a venipuncture site,” Dr. Hanrahan noted. “When possible you should avoid this.”
It’s also important to remember that 10% of fever in hospitalized individuals is from a noninfectious source. “Take a careful history, and do a physical exam to help distinguish infections from other causes of fever,” said Dr. Hanrahan.
Additional investigations to consider in highly immunocompromised patients might include both mycobacterial and fungal cultures, although these studies are otherwise generally low yield. And, she said, “Don’t send catheter-tip cultures – it’s pointless, and it really doesn’t add much information.”
Good clinical judgment still goes a long way toward guiding therapy. “If a patient is stable and it’s not clear whether an antibiotic is needed, consider waiting and re-evaluating later,” Dr. Hanrahan said.
Generally, duration of treatment should also be clinically based. “Stop antibiotics as soon as possible, and remove catheters as soon as possible,” Dr. Hanrahan said, adding that few infections really warrant treatment for a fixed amount of time. These include meningitis, endocarditis, tuberculosis, and many cases of osteomyelitis.
Similarly, when a patient who had been ill now looks well, feels well, and is stable or improving, there’s usually no need for repeat blood cultures, Dr. Hanrahan said. Still, a cautious balance is where most clinicians will wind up.
“I learned a long time ago that I have to do the things that let me go home and sleep at night,” she concluded.
Dr. Hanrahan reported having been a consultant for Gilead, Astellas, and Cempra.
ORLANDO – When is it rational to consider de-escalating, or even stopping, antibiotics for septic patients, and how will patients’ future health be affected by antibiotic use during critical illnesses?
According to Jennifer Hanrahan, DO, of Case Western Reserve University, Cleveland, locating the tipping point between optimal care for the individual patient in sepsis, and the importance of antibiotic stewardship is a balancing act. It’s a process guided by laboratory findings, by knowledge of local pathogens and patterns of antimicrobial resistance, and also by clinical judgment, she said at the annual meeting of the Society of Hospital Medicine.
By all means, begin antibiotics for patients with sepsis, Dr. Hanrahan, also medical director of infection prevention at MetroHealth Medical Center, Cleveland, told attendees at a pre-course at HM18. “Prompt initiation of antibiotics for sepsis is critical, and appropriate use of antibiotics decreases mortality.” However, she noted, de-escalation of antibiotics also decreases mortality.
“What is antibiotic stewardship? Most of us think of this as the microbial stewardship police calling to ask you, ‘Why are you using this antibiotic?’’ she said. “It’s really the right antibiotic, for the right diagnosis, for the appropriate duration.”
Of course, Dr. Hanrahan said, any medication is associated with potential adverse events, and antibiotics are no different. “Almost one-third of antibiotics given are either unnecessary or inappropriate,” she said.
Antimicrobial resistance is a very serious public health threat, Dr. Hanrahan affirmed. “Antibiotic use is the most important modifiable factor related to development of antibiotic resistance. With regard to multidrug resistant [MDR] gram negatives, we are running out of antibiotics” to treat these organisms, she said, noting that “Many antibiotics to treat MDRs are “astronomically expensive – and that’s a really big problem.”
It’s important to remember that, when antibiotics are prescribed, “You’re affecting the microbiome not just of that patient, but of those around them,” as resistance factors are potentially spread from one individual’s microbiome to their friends, family, and other contacts, Dr. Hanrahan said.
The later risk of sepsis has also shown to be elevated for individuals who have received high-risk antibiotics such as fluoroquinolones, third- and fourth-generation cephalosporins, beta-lactamase inhibitor formulations, vancomycin, and carbapenems – many of which are also used to treat sepsis. All of these antibiotics kill anaerobic bacteria, Dr. Hanrahan said, and “when you kill anaerobes you do a lot of bad things to people.”
Identifying the pathogens
There are already many frightening players in the antibiotic-resistant landscape. Among them are carbapenem-resistant Enterobacteriaceae, increasingly common in health care settings. Unfortunately, with methicillin-resistant Staphylococcus aureus (MRSA), “we’ve lost the battle,” Dr. Hanrahan said.
Acinetobacter is another increasing threat, she said, as is Candida auris, which has caused large outbreaks in Europe. Because it’s resistant to azole antifungals, once C. auris comes to U.S. hospitals, “You’re going to have a really big problem,” she said. Finally, multidrug resistant and extremely drug resistant Pseudomonas species are being encountered with increasing frequency.
And, of course, Clostridium difficile infections continue to ravage older populations. “One in 11 people aged 65 or older will die from C. diff infections,” said Dr. Hanrahan.
For all of these bacteria, she said, “I can’t tell you what antibiotics to use because you have to know what the organisms are in your hospital.” A good resource for tracking local resistance patterns is the information provided by the Centers for Disease Control and Prevention, including interactive maps showing health care–associated infections, as well as HealthMap ResistanceOpen, which maps antibiotic resistance alerts across the United States. The CDC also offers training on antibiotic stewardship; Dr. Hanrahan said the several hours she spent completing the training were well spent.
After a broad-spectrum antibiotic is initiated for sepsis, Dr. Hanrahan said that the next infectious disease–related steps should focus on identifying pathogens so antimicrobial therapy can be tailored or scaled back appropriately. In many cases, this will mean obtaining blood cultures – ideally, two sets from two separate sites. It’s no longer thought necessary to separate the blood draws by 20 minutes, or to try to time the draw during a febrile episode, she said.
What is important is to make sure that you’re not treating contamination or colonization – “Treat only clinically significant infections,” Dr. Hanrahan said. A common red herring, especially among elderly individuals coming from assisted living or in patients with indwelling urinary catheters, is a positive urine culture in the absence of signs or symptoms of urinary tract infection. Think twice about whether this truly represents a source of infection, she said. “Don’t treat asymptomatic bacteriuria.”
In order to avoid “chasing contamination,” do not obtain the blood culture samples from a venipuncture site. “Contamination is twice as likely when drawing from a venipuncture site,” Dr. Hanrahan noted. “When possible you should avoid this.”
It’s also important to remember that 10% of fever in hospitalized individuals is from a noninfectious source. “Take a careful history, and do a physical exam to help distinguish infections from other causes of fever,” said Dr. Hanrahan.
Additional investigations to consider in highly immunocompromised patients might include both mycobacterial and fungal cultures, although these studies are otherwise generally low yield. And, she said, “Don’t send catheter-tip cultures – it’s pointless, and it really doesn’t add much information.”
Good clinical judgment still goes a long way toward guiding therapy. “If a patient is stable and it’s not clear whether an antibiotic is needed, consider waiting and re-evaluating later,” Dr. Hanrahan said.
Generally, duration of treatment should also be clinically based. “Stop antibiotics as soon as possible, and remove catheters as soon as possible,” Dr. Hanrahan said, adding that few infections really warrant treatment for a fixed amount of time. These include meningitis, endocarditis, tuberculosis, and many cases of osteomyelitis.
Similarly, when a patient who had been ill now looks well, feels well, and is stable or improving, there’s usually no need for repeat blood cultures, Dr. Hanrahan said. Still, a cautious balance is where most clinicians will wind up.
“I learned a long time ago that I have to do the things that let me go home and sleep at night,” she concluded.
Dr. Hanrahan reported having been a consultant for Gilead, Astellas, and Cempra.
REPORTING FROM HM18
Brief stress management training helps teens with mental health complaints
TORONTO – A brief stress management intervention left a lasting effect on adolescents referred for mental health–related complaints, significantly reducing perceived distress, and heart rate variability. The majority of recipients expressed interest in additional training at follow-up.
Elizabeth B. Mason, MD, and her colleagues from Rainbow Babies and Children’s Hospital in Cleveland, reported in a poster presentation at the Pediatric Academic Societies annual meeting.
The vast majority of participants (96.5%) were African American, mean age was 16 years, and 36% were male. Cutoff criteria for generalized anxiety on the SCARED was met by 35 (41%) participants, and 23 (27%) participants scored positive for depression on the PHQ-A.
Following completion of preintervention questionnaires, 50 of 86 (58%) participants received psychoeducation from an adolescent medicine fellow or a pediatric psychologist on the effect stress has on the body, training in diaphragmatic breathing and progressive muscle relaxation, and no-cost/low-cost exercise options. Study participants also engaged in a peripheral biofeedback program called Unyte that has been shown to improve heart rate variability. The remaining 36 participants received no training and served as controls.
Those in the intervention group had significantly lower SUDS scores postintervention than did the control group. Heart rate variability coherence rates also decreased significantly postintervention in those who received the intervention, compared with controls.
When reached by phone 1 week after the session, 92% of participants said they found the intervention helpful and felt more relaxed, and 44% expressed interest in additional relaxation training.
The investigators concluded that “the results of this study suggest that a brief stress management intervention in an urban adolescent medicine clinic is effective at decreasing subjective distress and improving heart rate variability coherence rates. Future studies should include a control group and longer-term follow-up.”
TORONTO – A brief stress management intervention left a lasting effect on adolescents referred for mental health–related complaints, significantly reducing perceived distress, and heart rate variability. The majority of recipients expressed interest in additional training at follow-up.
Elizabeth B. Mason, MD, and her colleagues from Rainbow Babies and Children’s Hospital in Cleveland, reported in a poster presentation at the Pediatric Academic Societies annual meeting.
The vast majority of participants (96.5%) were African American, mean age was 16 years, and 36% were male. Cutoff criteria for generalized anxiety on the SCARED was met by 35 (41%) participants, and 23 (27%) participants scored positive for depression on the PHQ-A.
Following completion of preintervention questionnaires, 50 of 86 (58%) participants received psychoeducation from an adolescent medicine fellow or a pediatric psychologist on the effect stress has on the body, training in diaphragmatic breathing and progressive muscle relaxation, and no-cost/low-cost exercise options. Study participants also engaged in a peripheral biofeedback program called Unyte that has been shown to improve heart rate variability. The remaining 36 participants received no training and served as controls.
Those in the intervention group had significantly lower SUDS scores postintervention than did the control group. Heart rate variability coherence rates also decreased significantly postintervention in those who received the intervention, compared with controls.
When reached by phone 1 week after the session, 92% of participants said they found the intervention helpful and felt more relaxed, and 44% expressed interest in additional relaxation training.
The investigators concluded that “the results of this study suggest that a brief stress management intervention in an urban adolescent medicine clinic is effective at decreasing subjective distress and improving heart rate variability coherence rates. Future studies should include a control group and longer-term follow-up.”
TORONTO – A brief stress management intervention left a lasting effect on adolescents referred for mental health–related complaints, significantly reducing perceived distress, and heart rate variability. The majority of recipients expressed interest in additional training at follow-up.
Elizabeth B. Mason, MD, and her colleagues from Rainbow Babies and Children’s Hospital in Cleveland, reported in a poster presentation at the Pediatric Academic Societies annual meeting.
The vast majority of participants (96.5%) were African American, mean age was 16 years, and 36% were male. Cutoff criteria for generalized anxiety on the SCARED was met by 35 (41%) participants, and 23 (27%) participants scored positive for depression on the PHQ-A.
Following completion of preintervention questionnaires, 50 of 86 (58%) participants received psychoeducation from an adolescent medicine fellow or a pediatric psychologist on the effect stress has on the body, training in diaphragmatic breathing and progressive muscle relaxation, and no-cost/low-cost exercise options. Study participants also engaged in a peripheral biofeedback program called Unyte that has been shown to improve heart rate variability. The remaining 36 participants received no training and served as controls.
Those in the intervention group had significantly lower SUDS scores postintervention than did the control group. Heart rate variability coherence rates also decreased significantly postintervention in those who received the intervention, compared with controls.
When reached by phone 1 week after the session, 92% of participants said they found the intervention helpful and felt more relaxed, and 44% expressed interest in additional relaxation training.
The investigators concluded that “the results of this study suggest that a brief stress management intervention in an urban adolescent medicine clinic is effective at decreasing subjective distress and improving heart rate variability coherence rates. Future studies should include a control group and longer-term follow-up.”
REPORTING FROM PAS 2018
Key clinical point: A brief stress management intervention had a lasting effect on adolescents referred for mental health–related complaints.
Major finding: Nearly all participants found the intervention helpful and felt more relaxed and 44% were interested in additional training.
Study details: A randomized trial including 86 adolescents (mean age, 16 years) referred for anxiety, somatic complaints, or difficulty managing mood.
Disclosures: The investigators reported no conflict of interest.
FDA Commissioner Comments on Signing of the Right to Try Act
SILVER SPRING, MD—On May 30, 2018, President Donald Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Right to Try Act). This new law amends the Federal Food, Drug, and Cosmetic Act to establish a new pathway aimed at increasing access to unapproved, investigational treatments for patients diagnosed with life-threatening diseases or conditions who have exhausted
“For patients with serious or immediately life-threatening diseases, the FDA remains committed to enhancing access to promising investigational medicines for those unable to access products through clinical trials,” said Dr. Gottlieb. “This is the mission of our expanded access program. The agency is dedicated to these purposes, and it has been for more than three decades.”
“We’ve taken many steps to improve our process through which patients can access promising investigational drugs,” said Dr. Gottlieb. “We understand that treatment decisions for those facing terminal illnesses are best made by patients and families, with the support of their treating physicians. When appropriate, those suffering from a terminal illness who’ve exhausted available options should be able to access promising treatments being studied in clinical trials, or products under active review by the FDA. The agency is faithfully committed to these goals, to protecting patients, and to making sure they’re able to make informed decisions.”
“We stand ready to implement this legislation in a way that achieves Congress’ intent to promote access and protect patients. The FDA is dedicated to achieving the goals that Congress set forth in this legislation, so that patients facing terminal conditions have an additional avenue to access promising investigational medicines.”
“The decisions we reach related to products that can serve as an effective treatment for a terminal illness, or that can arrest a devastating and debilitating condition, are among the most important and carefully considered judgments that we make,” said Dr. Gottlieb. “We recognize the important balance between making sure patients have the assurances Congress intends, while enabling timely access to promising treatments in these devastating circumstances. And we’ll implement this new law consistent with these longstanding values.”
SILVER SPRING, MD—On May 30, 2018, President Donald Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Right to Try Act). This new law amends the Federal Food, Drug, and Cosmetic Act to establish a new pathway aimed at increasing access to unapproved, investigational treatments for patients diagnosed with life-threatening diseases or conditions who have exhausted
“For patients with serious or immediately life-threatening diseases, the FDA remains committed to enhancing access to promising investigational medicines for those unable to access products through clinical trials,” said Dr. Gottlieb. “This is the mission of our expanded access program. The agency is dedicated to these purposes, and it has been for more than three decades.”
“We’ve taken many steps to improve our process through which patients can access promising investigational drugs,” said Dr. Gottlieb. “We understand that treatment decisions for those facing terminal illnesses are best made by patients and families, with the support of their treating physicians. When appropriate, those suffering from a terminal illness who’ve exhausted available options should be able to access promising treatments being studied in clinical trials, or products under active review by the FDA. The agency is faithfully committed to these goals, to protecting patients, and to making sure they’re able to make informed decisions.”
“We stand ready to implement this legislation in a way that achieves Congress’ intent to promote access and protect patients. The FDA is dedicated to achieving the goals that Congress set forth in this legislation, so that patients facing terminal conditions have an additional avenue to access promising investigational medicines.”
“The decisions we reach related to products that can serve as an effective treatment for a terminal illness, or that can arrest a devastating and debilitating condition, are among the most important and carefully considered judgments that we make,” said Dr. Gottlieb. “We recognize the important balance between making sure patients have the assurances Congress intends, while enabling timely access to promising treatments in these devastating circumstances. And we’ll implement this new law consistent with these longstanding values.”
SILVER SPRING, MD—On May 30, 2018, President Donald Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Right to Try Act). This new law amends the Federal Food, Drug, and Cosmetic Act to establish a new pathway aimed at increasing access to unapproved, investigational treatments for patients diagnosed with life-threatening diseases or conditions who have exhausted
“For patients with serious or immediately life-threatening diseases, the FDA remains committed to enhancing access to promising investigational medicines for those unable to access products through clinical trials,” said Dr. Gottlieb. “This is the mission of our expanded access program. The agency is dedicated to these purposes, and it has been for more than three decades.”
“We’ve taken many steps to improve our process through which patients can access promising investigational drugs,” said Dr. Gottlieb. “We understand that treatment decisions for those facing terminal illnesses are best made by patients and families, with the support of their treating physicians. When appropriate, those suffering from a terminal illness who’ve exhausted available options should be able to access promising treatments being studied in clinical trials, or products under active review by the FDA. The agency is faithfully committed to these goals, to protecting patients, and to making sure they’re able to make informed decisions.”
“We stand ready to implement this legislation in a way that achieves Congress’ intent to promote access and protect patients. The FDA is dedicated to achieving the goals that Congress set forth in this legislation, so that patients facing terminal conditions have an additional avenue to access promising investigational medicines.”
“The decisions we reach related to products that can serve as an effective treatment for a terminal illness, or that can arrest a devastating and debilitating condition, are among the most important and carefully considered judgments that we make,” said Dr. Gottlieb. “We recognize the important balance between making sure patients have the assurances Congress intends, while enabling timely access to promising treatments in these devastating circumstances. And we’ll implement this new law consistent with these longstanding values.”
A methylene blue dye pill sheds light on hard-to-see polyps
A methylene blue dye pill increases the adenoma detection rate in patients undergoing colonoscopy screenings.
“An oral, delayed-release, methylene blue tablet taken during the standard bowel preparation for colonoscopy has the potential to increase the adenoma detection rate and could assist in the early detection and prevention of colorectal cancer,” according to Michael B. Wallace, MD, professor of medicine and director of digestive disease research at the Mayo Clinic in Jacksonville, Fla.
“The number of polyps that providers find during a screening colonoscopy and remove is referred to as the adenoma detection rate. This is the most widely accepted national benchmark on quality for screening colonoscopy,” Dr. Wallace said in a media briefing in advance of the annual Digestive Disease Week®.
Dr. Wallace pointed out that missed adenomas tend to go on and develop into cancer.
“The ones that are most frequently missed are typically called ‘flat’ or ‘subtle’ polyps, making them very difficult to identify,” he said. “If they cannot be identified, they cannot be removed.”
The study involved more than 1,200 patients scheduled for colonoscopies at 20 centers around the world. Patients were randomly assigned to receive a full dose of the methylene blue dye, a half dose, or placebo. Patients receiving a half dose were not included in the statistical analysis, but served the purpose of not allowing doctors to know which patients were in the study group. Dr. Wallace noted that the nature of this study made it impossible to perform a truly double-blind study because the blue dye is visible during colonoscopy.
For the patients who took the full dose of methylene blue, the adenoma detection rate increased by nearly 9%, compared with the placebo group, with detection rates of 56.29% and 47.81%, respectively.
“While 9% may not actually seem like a large number, it is actually very clinically significant,” Dr. Wallace said. For every 1% increase in the absolute adenoma detection rate, there was a corresponding 3% decline in the incidence of colorectal cancer and a 5% decline in colorectal cancer deaths.
While the results of this study are overwhelmingly positive, Dr. Wallace pointed out that utilizing blue dye to increase adenoma detection rate is not a new concept, with a number of clinical trials showing its benefit.
Apart from improving adenoma detection rates, the tablet formulation of methylene blue dye no longer requires on-site mixing by providers. This was a limiting factor because the dye itself is difficult to mix and hard to obtain for many health care centers around the world. The mixed solution was also not as effective because it was sprayed during colonoscopies. Dr. Wallace asserted that spraying through the colonoscope could be imprecise, time consuming, and localized. For these reasons, this technique was never widely adopted. The primary advantage of the tablet formulation is that it releases the dye in the colon at or near the time of the colonoscopy.
Dr. Wallace emphasized that there is no substitute for good colonoscopy practice and that methylene blue is just another tool to help improve the practice.
“The oral, delayed-release methylene blue provides gastroenterologists with a new and supplemental method to improve their adenoma detection rate on top of what is otherwise a high-quality examination.
A methylene blue dye pill increases the adenoma detection rate in patients undergoing colonoscopy screenings.
“An oral, delayed-release, methylene blue tablet taken during the standard bowel preparation for colonoscopy has the potential to increase the adenoma detection rate and could assist in the early detection and prevention of colorectal cancer,” according to Michael B. Wallace, MD, professor of medicine and director of digestive disease research at the Mayo Clinic in Jacksonville, Fla.
“The number of polyps that providers find during a screening colonoscopy and remove is referred to as the adenoma detection rate. This is the most widely accepted national benchmark on quality for screening colonoscopy,” Dr. Wallace said in a media briefing in advance of the annual Digestive Disease Week®.
Dr. Wallace pointed out that missed adenomas tend to go on and develop into cancer.
“The ones that are most frequently missed are typically called ‘flat’ or ‘subtle’ polyps, making them very difficult to identify,” he said. “If they cannot be identified, they cannot be removed.”
The study involved more than 1,200 patients scheduled for colonoscopies at 20 centers around the world. Patients were randomly assigned to receive a full dose of the methylene blue dye, a half dose, or placebo. Patients receiving a half dose were not included in the statistical analysis, but served the purpose of not allowing doctors to know which patients were in the study group. Dr. Wallace noted that the nature of this study made it impossible to perform a truly double-blind study because the blue dye is visible during colonoscopy.
For the patients who took the full dose of methylene blue, the adenoma detection rate increased by nearly 9%, compared with the placebo group, with detection rates of 56.29% and 47.81%, respectively.
“While 9% may not actually seem like a large number, it is actually very clinically significant,” Dr. Wallace said. For every 1% increase in the absolute adenoma detection rate, there was a corresponding 3% decline in the incidence of colorectal cancer and a 5% decline in colorectal cancer deaths.
While the results of this study are overwhelmingly positive, Dr. Wallace pointed out that utilizing blue dye to increase adenoma detection rate is not a new concept, with a number of clinical trials showing its benefit.
Apart from improving adenoma detection rates, the tablet formulation of methylene blue dye no longer requires on-site mixing by providers. This was a limiting factor because the dye itself is difficult to mix and hard to obtain for many health care centers around the world. The mixed solution was also not as effective because it was sprayed during colonoscopies. Dr. Wallace asserted that spraying through the colonoscope could be imprecise, time consuming, and localized. For these reasons, this technique was never widely adopted. The primary advantage of the tablet formulation is that it releases the dye in the colon at or near the time of the colonoscopy.
Dr. Wallace emphasized that there is no substitute for good colonoscopy practice and that methylene blue is just another tool to help improve the practice.
“The oral, delayed-release methylene blue provides gastroenterologists with a new and supplemental method to improve their adenoma detection rate on top of what is otherwise a high-quality examination.
A methylene blue dye pill increases the adenoma detection rate in patients undergoing colonoscopy screenings.
“An oral, delayed-release, methylene blue tablet taken during the standard bowel preparation for colonoscopy has the potential to increase the adenoma detection rate and could assist in the early detection and prevention of colorectal cancer,” according to Michael B. Wallace, MD, professor of medicine and director of digestive disease research at the Mayo Clinic in Jacksonville, Fla.
“The number of polyps that providers find during a screening colonoscopy and remove is referred to as the adenoma detection rate. This is the most widely accepted national benchmark on quality for screening colonoscopy,” Dr. Wallace said in a media briefing in advance of the annual Digestive Disease Week®.
Dr. Wallace pointed out that missed adenomas tend to go on and develop into cancer.
“The ones that are most frequently missed are typically called ‘flat’ or ‘subtle’ polyps, making them very difficult to identify,” he said. “If they cannot be identified, they cannot be removed.”
The study involved more than 1,200 patients scheduled for colonoscopies at 20 centers around the world. Patients were randomly assigned to receive a full dose of the methylene blue dye, a half dose, or placebo. Patients receiving a half dose were not included in the statistical analysis, but served the purpose of not allowing doctors to know which patients were in the study group. Dr. Wallace noted that the nature of this study made it impossible to perform a truly double-blind study because the blue dye is visible during colonoscopy.
For the patients who took the full dose of methylene blue, the adenoma detection rate increased by nearly 9%, compared with the placebo group, with detection rates of 56.29% and 47.81%, respectively.
“While 9% may not actually seem like a large number, it is actually very clinically significant,” Dr. Wallace said. For every 1% increase in the absolute adenoma detection rate, there was a corresponding 3% decline in the incidence of colorectal cancer and a 5% decline in colorectal cancer deaths.
While the results of this study are overwhelmingly positive, Dr. Wallace pointed out that utilizing blue dye to increase adenoma detection rate is not a new concept, with a number of clinical trials showing its benefit.
Apart from improving adenoma detection rates, the tablet formulation of methylene blue dye no longer requires on-site mixing by providers. This was a limiting factor because the dye itself is difficult to mix and hard to obtain for many health care centers around the world. The mixed solution was also not as effective because it was sprayed during colonoscopies. Dr. Wallace asserted that spraying through the colonoscope could be imprecise, time consuming, and localized. For these reasons, this technique was never widely adopted. The primary advantage of the tablet formulation is that it releases the dye in the colon at or near the time of the colonoscopy.
Dr. Wallace emphasized that there is no substitute for good colonoscopy practice and that methylene blue is just another tool to help improve the practice.
“The oral, delayed-release methylene blue provides gastroenterologists with a new and supplemental method to improve their adenoma detection rate on top of what is otherwise a high-quality examination.
Colonic diverticulosis not linked to mucosal inflammation, GI symptoms
Colonic diverticulosis was not associated with mucosal inflammation or gastrointestinal symptoms in a single-center, prospective study of adults undergoing their first screening colonoscopy.
After adjustment for age, sex, and body mass index, there were no significant links between diverticulosis and tumor necrosis factor, CD4+ cells, CD8+ cells, CD57+ cells, irritable bowel syndrome, or chronic abdominal pain, reported Anne F. Peery, MD, with her associates at the University of North Carolina at Chapel Hill. “Our findings strongly question the rationale for treating symptomatic uncomplicated diverticular disease with mesalamine,” they wrote in the June issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2017.05.051).
Colonic diverticula affect more than half of individuals in the United States over the age of 60 years, according to the results of past studies. “Although colonic diverticulosis can be complicated by the overt inflammation of acute diverticulitis, there is some thought that colonic diverticulosis is associated with low-grade mucosal inflammation,” the researchers said. “Moreover, this low-grade diverticular inflammation is believed to contribute to chronic gastrointestinal symptoms.” However, no rigorous prospective study had tested these assertions.
Accordingly, the researchers evaluated prospective data from 619 outpatients aged 30 years and older who underwent screening colonoscopies for the first time during 2013-2015. These patients had consented to participate in a study of risk factors for colonic diverticulosis. Most were white (76%) or black (21%), and most were aged 50-59 years.
A total of 255 individuals had diverticula while 364 controls did not. Patients with diverticula tended to be older and were more often male (47% vs. 41% of controls) and overweight or obese (72% vs. 62%). After adjustment for age, sex, and body mass index, there was no evidence linking diverticulosis with tumor necrosis factor alpha expression (odds ratio, 0.9; 95% confidence interval, 0.6-1.2), CD4+ cells (OR, 1.2; 95% CI, 0.9-1.6), CD8+ cells (OR, 1.0; 95% CI, 0.7-1.3), or CD57+ cells (OR, 0.8; 95% CI, 0.6-1.1).
Among 42 patients who met Rome III criteria for irritable bowel syndrome, 11 had diverticulosis. Diverticulosis in IBS was not associated with changes in expression of the mucosal inflammatory markers interleukin-6, interleukin-10, tumor necrosis factor, CD4, CD8, or mast cell tryptase, said the researchers. A total of 63 patients had chronic abdominal pain, of whom 22 also had diverticulosis. There were no significant differences in mucosal inflammatory markers between symptomatic patients with diverticula and those without. Adjusted analysis found no association between number of diverticula and chronic abdominal pain (OR, 0.7; 95% CI, 0.4-1.2) or IBS (OR, 0.5; 95% CI, 0.3-1.1).
The number of patients with IBS in this study was small, and the researchers did not ascertain IBS symptom severity, they noted. “Although we studied several immune markers and cytokines, there are other potential markers that may be associated with chronic inflammation,” they added. “Multianalyte profiling could be used to assess an array of cytokines, and markers for macrophages (CD68), global T cells (CD3), and B cells (CD19). Whether there is utility in further studies given our negative results is debatable.”
The National Institutes of Health provided funding. The investigators reported having no conflicts of interest.
SOURCE: Peery AF et al. Clin Gastroenterol Hepatol. 2017 Jun 8. doi: 10.1016/j.cgh.2017.05.051.
Colonic diverticulosis was not associated with mucosal inflammation or gastrointestinal symptoms in a single-center, prospective study of adults undergoing their first screening colonoscopy.
After adjustment for age, sex, and body mass index, there were no significant links between diverticulosis and tumor necrosis factor, CD4+ cells, CD8+ cells, CD57+ cells, irritable bowel syndrome, or chronic abdominal pain, reported Anne F. Peery, MD, with her associates at the University of North Carolina at Chapel Hill. “Our findings strongly question the rationale for treating symptomatic uncomplicated diverticular disease with mesalamine,” they wrote in the June issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2017.05.051).
Colonic diverticula affect more than half of individuals in the United States over the age of 60 years, according to the results of past studies. “Although colonic diverticulosis can be complicated by the overt inflammation of acute diverticulitis, there is some thought that colonic diverticulosis is associated with low-grade mucosal inflammation,” the researchers said. “Moreover, this low-grade diverticular inflammation is believed to contribute to chronic gastrointestinal symptoms.” However, no rigorous prospective study had tested these assertions.
Accordingly, the researchers evaluated prospective data from 619 outpatients aged 30 years and older who underwent screening colonoscopies for the first time during 2013-2015. These patients had consented to participate in a study of risk factors for colonic diverticulosis. Most were white (76%) or black (21%), and most were aged 50-59 years.
A total of 255 individuals had diverticula while 364 controls did not. Patients with diverticula tended to be older and were more often male (47% vs. 41% of controls) and overweight or obese (72% vs. 62%). After adjustment for age, sex, and body mass index, there was no evidence linking diverticulosis with tumor necrosis factor alpha expression (odds ratio, 0.9; 95% confidence interval, 0.6-1.2), CD4+ cells (OR, 1.2; 95% CI, 0.9-1.6), CD8+ cells (OR, 1.0; 95% CI, 0.7-1.3), or CD57+ cells (OR, 0.8; 95% CI, 0.6-1.1).
Among 42 patients who met Rome III criteria for irritable bowel syndrome, 11 had diverticulosis. Diverticulosis in IBS was not associated with changes in expression of the mucosal inflammatory markers interleukin-6, interleukin-10, tumor necrosis factor, CD4, CD8, or mast cell tryptase, said the researchers. A total of 63 patients had chronic abdominal pain, of whom 22 also had diverticulosis. There were no significant differences in mucosal inflammatory markers between symptomatic patients with diverticula and those without. Adjusted analysis found no association between number of diverticula and chronic abdominal pain (OR, 0.7; 95% CI, 0.4-1.2) or IBS (OR, 0.5; 95% CI, 0.3-1.1).
The number of patients with IBS in this study was small, and the researchers did not ascertain IBS symptom severity, they noted. “Although we studied several immune markers and cytokines, there are other potential markers that may be associated with chronic inflammation,” they added. “Multianalyte profiling could be used to assess an array of cytokines, and markers for macrophages (CD68), global T cells (CD3), and B cells (CD19). Whether there is utility in further studies given our negative results is debatable.”
The National Institutes of Health provided funding. The investigators reported having no conflicts of interest.
SOURCE: Peery AF et al. Clin Gastroenterol Hepatol. 2017 Jun 8. doi: 10.1016/j.cgh.2017.05.051.
Colonic diverticulosis was not associated with mucosal inflammation or gastrointestinal symptoms in a single-center, prospective study of adults undergoing their first screening colonoscopy.
After adjustment for age, sex, and body mass index, there were no significant links between diverticulosis and tumor necrosis factor, CD4+ cells, CD8+ cells, CD57+ cells, irritable bowel syndrome, or chronic abdominal pain, reported Anne F. Peery, MD, with her associates at the University of North Carolina at Chapel Hill. “Our findings strongly question the rationale for treating symptomatic uncomplicated diverticular disease with mesalamine,” they wrote in the June issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2017.05.051).
Colonic diverticula affect more than half of individuals in the United States over the age of 60 years, according to the results of past studies. “Although colonic diverticulosis can be complicated by the overt inflammation of acute diverticulitis, there is some thought that colonic diverticulosis is associated with low-grade mucosal inflammation,” the researchers said. “Moreover, this low-grade diverticular inflammation is believed to contribute to chronic gastrointestinal symptoms.” However, no rigorous prospective study had tested these assertions.
Accordingly, the researchers evaluated prospective data from 619 outpatients aged 30 years and older who underwent screening colonoscopies for the first time during 2013-2015. These patients had consented to participate in a study of risk factors for colonic diverticulosis. Most were white (76%) or black (21%), and most were aged 50-59 years.
A total of 255 individuals had diverticula while 364 controls did not. Patients with diverticula tended to be older and were more often male (47% vs. 41% of controls) and overweight or obese (72% vs. 62%). After adjustment for age, sex, and body mass index, there was no evidence linking diverticulosis with tumor necrosis factor alpha expression (odds ratio, 0.9; 95% confidence interval, 0.6-1.2), CD4+ cells (OR, 1.2; 95% CI, 0.9-1.6), CD8+ cells (OR, 1.0; 95% CI, 0.7-1.3), or CD57+ cells (OR, 0.8; 95% CI, 0.6-1.1).
Among 42 patients who met Rome III criteria for irritable bowel syndrome, 11 had diverticulosis. Diverticulosis in IBS was not associated with changes in expression of the mucosal inflammatory markers interleukin-6, interleukin-10, tumor necrosis factor, CD4, CD8, or mast cell tryptase, said the researchers. A total of 63 patients had chronic abdominal pain, of whom 22 also had diverticulosis. There were no significant differences in mucosal inflammatory markers between symptomatic patients with diverticula and those without. Adjusted analysis found no association between number of diverticula and chronic abdominal pain (OR, 0.7; 95% CI, 0.4-1.2) or IBS (OR, 0.5; 95% CI, 0.3-1.1).
The number of patients with IBS in this study was small, and the researchers did not ascertain IBS symptom severity, they noted. “Although we studied several immune markers and cytokines, there are other potential markers that may be associated with chronic inflammation,” they added. “Multianalyte profiling could be used to assess an array of cytokines, and markers for macrophages (CD68), global T cells (CD3), and B cells (CD19). Whether there is utility in further studies given our negative results is debatable.”
The National Institutes of Health provided funding. The investigators reported having no conflicts of interest.
SOURCE: Peery AF et al. Clin Gastroenterol Hepatol. 2017 Jun 8. doi: 10.1016/j.cgh.2017.05.051.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Key clinical point: Colonic diverticula were not associated with mucosal inflammation or chronic gastrointestinal symptoms.
Major finding: After adjustment for possible confounders, there were no significant associations between diverticulosis and tumor necrosis factor, CD4+ cells, CD8+ cells, CD57+ cells, irritable bowel syndrome, or chronic abdominal pain.
Study details: Single-center prospective study of 619 patients undergoing screening colonoscopies.
Disclosures: The National Institutes of Health provided funding. The investigators reported having no conflicts of interest.
Source: Peery AF et al. Clin Gastroenterol Hepatol. 2017 Jun 8. doi: 10.1016/j.cgh.2017.05.051
Lessons from a daunting malpractice event
CASE Failure to perform cesarean delivery1–4
A 19-year-old woman (G1P0) received prenatal care at a federally funded health center. Her pregnancy was normal without complications. She presented to the hospital after spontaneous rupture of membranes (SROM). The on-call ObGyn employed by the clinic was offsite when the mother was admitted.
The mother signed a standard consent form for vaginal and cesarean deliveries and any other surgical procedure required during the course of giving birth.
The ObGyn ordered low-dose oxytocin to augment labor in light of her SROM. Oxytocin was started at 9:46
Upon delivery, the infant was flaccid and not breathing. His Apgar scores were 2, 3, and 6 at 1, 5, and 10 minutes, respectively, and the cord pH was 7. The neonatal intensive care (NICU) team provided aggressive resuscitation.
At the time of trial, the 18-month-old boy was being fed through a percutaneous endoscopic gastrostomy tube and had a tracheostomy that required periodic suctioning. The child was not able to stand, crawl, or support himself, and will require 24-hour nursing care for the rest of his life.
LAWSUIT. The parents filed a lawsuit in federal court for damages under the Federal Tort Claims Act (see “Notes about this case,”). The mother claimed that she had requested a cesarean delivery early in labor when FHR tracings showed fetal distress, and again prior to vacuum extraction; the ObGyn refused both times.
The ObGyn claimed that when he noted a category III tracing, he recommended cesarean delivery, but the patient refused. He recorded the refusal in the chart some time later, after he had noted the neonate’s appearance.
The parents’ expert testified that restarting oxytocin and using vacuum extraction multiple times were dangerous and gross deviations from acceptable practice. Prolonged and repetitive use of the vacuum extractor caused a large subgaleal hematoma that decreased blood flow to the fetal brain, resulting in irreversible central nervous system (CNS) damage secondary to hypoxic ischemic encephalopathy. An emergency cesarean delivery should have been performed at the first sign of fetal distress.
The defense expert pointed out that the ObGyn discussed the need for cesarean delivery with the patient when fetal distress occurred and that the ObGyn was bedside and monitoring the fetus and the mother. Although the mother consented to a cesarean delivery at time of admission, she refused to allow the procedure.
The labor and delivery (L&D) nurse corroborated the mother’s story that a cesarean delivery was not offered by the ObGyn, and when the patient asked for a cesarean delivery, he refused. The nurse stated that the note added to the records by the ObGyn about the mother’s refusal was a lie. If the mother had refused a cesarean, the nurse would have documented the refusal by completing a Refusal of Treatment form that would have been faxed to the risk manager. No such form was required because nothing was ever offered that the mother refused.
The nurse also testified that during the course of the latter part of labor, the ObGyn left the room several times to assist other patients, deliver another baby, and make an 8-minute phone call to his stockbroker. She reported that the ObGyn was out of the room when delivery occurred.
WHAT’S THE VERDICT?
Read about the verdict and medical considerations.
WHAT’S THE VERDICT?
The medical care and the federal-court bench trial held in front of a judge (not a jury) occurred in Florida. The verdict suggests that the ObGyn breached the standard of care by not offering or proceeding with a cesarean delivery and this management resulted in the child’s injuries. The court awarded damages in the amount of $33,813,495.91, including $29,413,495.91 for the infant; $3,300,000.00 for the plaintiff; and $1,100,000.00 for her spouse.4
Medical considerations
Refusal of medical care
Although it appears that in this case the patient did not actually refuse medical care (cesarean delivery), the case does raise the question of refusal. Refusal of medical care has been addressed by the American College of Obstetricians and Gynecologists (ACOG) predicated upon care that supports maternal and fetal wellbeing.5 There may be a fine balance between safeguarding the pregnant woman’s autonomy and optimization of fetal wellbeing. “Forced compliance,” on the other hand, is the alternative to respecting refusal of treatment. Ethical issues come into play: patient rights; respect for autonomy; violations of bodily integrity; power differentials; and gender equality.5 The use of coercion is “not only ethically impermissible but also medically inadvisable secondary to the realities of prognostic uncertainty and the limitations of medical knowledge.”5 There is an obligation to elicit the patient’s reasoning and lived experience. Perhaps most importantly, as clinicians working to achieve a resolution, consideration of the following is appropriate5:
- reliability and validity of evidence-based medicine
- severity of the prospective outcome
- degree of risk or burden placed on the patient
- patient understanding of the gravity of the situation and risks
- degree of urgency.
Much of this boils down to the obligation to discuss “risks and benefits of treatment, alternatives and consequences of refusing treatment.”6
Complications from vacuum-assisted vaginal delivery
Ghidini and associates, in a multicenter retrospective study, evaluated complications relating to vacuum-assisted delivery. They listed major primary outcomes of subgaleal hemorrhage, skull fracture, and intracranial bleeding, and minor primary outcomes of cephalohematoma, scalp laceration, and extensive skin abrasions. Secondary outcomes included a 5-minute Apgar score of <7, umbilical artery pH of <7.10, shoulder dystocia, and NICU admission.7
A retrospective study from Sweden assessing all vacuum deliveries over a 2-year period compared the use of the Kiwi OmniCup (Clinical Innovations) to use of the Malmström metal cup (Medela). No statistical differences in maternal or neonatal outcomes as well as failure rates were noted. However, the duration of the procedure was longer and the requirement for fundal pressure was higher with the Malmström device.8
Subgaleal hemorrhage. Ghidini and colleagues reported a heightened incidence of head injury related to the duration of vacuum application and birth weight.7 Specifically, vacuum delivery devices increase the risk of subgaleal hemorrhage. Blood can accumulate between the scalp’s epicranial aponeurosis and the periosteum and potentially can extend forward to the orbital margins, backward to the nuchal ridge, and laterally to the temporal fascia. As much as 260 mL of blood can get into this subaponeurotic space in term babies.9 Up to one-quarter of babies who require NICU admission for this condition die.10 This injury seldom occurs with forceps.
Shoulder dystocia. In a meta-analysisfrom Italy, the vacuum extractor was associated with increased risk of shoulder dystocia compared with spontaneous vaginal delivery.11
Intrapartum hypoxia. In 2003, the ACOG Task Force on Neonatal Encephalopathy and Cerebral Palsy defined an acute intrapartum hypoxic event (TABLE).12
Cerebral palsy (CP) is defined as “a chronic neuromuscular disability characterized by aberrant control of movement or posture appearing early in life and not the result of recognized progressive disease.”13,14
The Collaborative Perinatal Project concluded that birth trauma plays a minimal role in development of CP.15 Arrested labor, use of oxytocin, or prolonged labor did not play a role. CP can develop following significant cerebral or posterior fossa hemorrhage in term infants.16
Perinatal asphyxia is a poor and imprecise term and use of the expression should be abandoned. Overall, 90% of children with CP do not have birth asphyxia as the underlying etiology.14
Prognostic assessment can be made, in part, by using the Sarnat classification system (classification scale for hypoxic-ischemic encephalopathy of the newborn) or an electroencephalogram to stratify the severity of neonatal encephalopathy.12 Such tests are not stand-alone but a segment of assessment. At this point “a better understanding of the processes leading to neonatal encephalopathy and associated outcomes” appear to be required to understand and associate outcomes.12 “More accurate and reliable tools (are required) for prognostic forecasting.”12
Hypoxic-ischemic encephalopathy involves multisystem organ failure including renal, hepatic, hematologic, cardiac, gastrointestinal, and metabolic abnormalities. There is no correlation between the degree of CNS injury and level of other organ abnormalities.12
Differential diagnosis
When events such as those described in this case occur, develop a differential diagnosis by considering the following12:
- uterine rupture
- severe placental abruption
- umbilical cord prolapse
- amniotic fluid embolus
- maternal cardiovascular collapse
- fetal exsanguination.
Read about the legal considerations.
Legal considerations
Although ObGyns are among the specialties most likely to experience malpractice claims,17 a verdict of more than $33 million is unusual.18 Despite the failure of adequate care, and the enormous damages, the ObGyn involved probably will not be responsible for paying the verdict (see “Notes about this case”). The case presents a number of important lessons and reminders for anyone practicing obstetrics.
A procedural comment
The case in this article arose under the Federal Tort Claims Act (FTCA).1 Most government entities have sovereign immunity, meaning that they can be sued only with their consent. In the FTCA, the federal government consented to being sued for the acts of its employees. This right has a number of limitations and some technical procedures, but at its core, it permits the United States to be sued as though it was a private individual.2 Private individuals can be sued for the acts of the agents (including employees).
Although the FTCA is a federal law, and these cases are tried in federal court, the substantive law of the state applies. This case occurred in Florida, so Florida tort law, defenses, and limitation on claims applied here also. Had the events occurred in Iowa, Iowa law would have applied.
In FTCA cases, the United States is the defendant (generally it is the government, not the employee who is the defendant).3 In this case, the ObGyn was employed by a federal government entity to provide delivery services. As a result, the United States was the primary defendant, had the obligation to defend the suit, and will almost certainly be obligated to pay the verdict.
The case facts
Although this description is based on an actual case, the facts were taken from the opinion of the trial court, legal summaries and press reports and not from the full case documents.4-7 We could not independently assess the accuracy of the facts, but for the purpose of this discussion, we have assumed the facts to be correct. The government has apparently filed an appeal in the Eleventh Circuit.
References
- Federal Tort Claims Act. Vol 28 U.S.C. Pt.VI Ch.171 and 28 U.S.C. § 1346(b).
- About the Federal Tort Claims Act (FTCA). Health Resources & Services Administration: Health Center Program. https://bphc.hrsa.gov/ftca/about/index.html. Accessed May 16, 2018.
- Dowell MA, Scott CD. Federally Qualified Health Center Federal Tort Claims Act Insurance Coverage. Health Law. 2015;5:31-43.
- Chang D. Miami doctor's call to broker during baby's delivery leads to $33.8 million judgment. Miami Herald. http://www.miamiherald.com/news/health-care/article147506019.html. Published April 28, 2017. Accessed January 11, 2018.
- Teller SE. $33.8 Million judgment reached in malpractice lawsuit. Legal Reader. https://www.legalreader.com/33-8-million-judgment-reached/. Published May 2017. Accessed May 16, 2018.
- Laska L. Medical Malpractice: Verdicts, Settlements, & Experts. 2017;33(11):17-18.
- Dixon v. U.S. Civil Action No. 15-23502-Civ-Scola. LEAGLE.com. https://www.leagle.com/decision/infdco20170501s18. Published April 28, 2017. Accessed May 8, 2018.
Very large verdict
The extraordinary size of this verdict ($33 million without any punitive damages) is a reminder that in obstetrics, mistakes can have catastrophic consequences and very high costs.19 This fact is reflected in malpractice insurance rates.
A substantial amount of this case’s award will provide around-the-clock care for the child. This verdict was not the result of a runaway jury—it was a judge’s decision. It is also noteworthy to report that a small percentage of physicians (1%) appear responsible for a significant number (about one-third) of paid claims.20
Although the size of the verdict is unusual, the case is a fairly straightforward negligence tort. The judge found that the ObGyn had breached the duty of care for his patient. The actions that fell below the standard of care included restarting the oxytocin, using the Kiwi vacuum device 3 times, and failing to perform a cesarean delivery in light of obvious fetal distress. That negligence caused injury to the infant (and his parents).21 The judge determined that the 4 elements of negligence were present: 1) duty of care, 2) breach of that duty, 3) injury, and 4) a causal link between the breach of duty and the injury. The failure to adhere to good practice standards practically defines breach of duty.22
Multitasking
One important lesson is that multitasking, absence, and inattention can look terrible when things go wrong. Known as “hindsight bias,” the awareness that there was a disastrous result makes it easier to attribute the outcome to small mistakes that otherwise might seem trivial. This ObGyn was in and out of the room during a difficult labor. Perhaps that was understandable if it were unavoidable because of another delivery, but being absent frequently and not present for the delivery now looks very significant.23 And, of course, the 8-minute phone call to the stockbroker shines as a heartless, self-centered act of inattention.
Manipulating the record
Another lesson of this case: Do not manipulate the record. The ObGyn recorded that the patient had refused the cesarean delivery he recommended. Had that been the truth, it would have substantially improved his case. But apparently it was not the truth. Although there was circumstantial evidence (the charting of the patient’s refusal only after the newborn’s condition was obvious, failure to complete appropriate hospital forms), the most damning evidence was the direct testimony of the L&D nurse. She reported that, contrary to what the ObGyn put in the chart, the patient requested a cesarean delivery. In truth, it was the ObGyn who had refused.
A physician who is dishonest with charting—making false statements or going back or “correcting” a chart later—loses credibility and the presumption of acting in good faith. That is disastrous for the physician.24
A hidden lesson
Another lesson, more human than legal, is that it matters how patients are treated when things go wrong. According to press reports, the parents felt that the ObGyn had not recognized that he had made any errors, did not apologize, and had even blamed the mother for the outcome. It does not require graduate work in psychology to expect that this approach would make the parents angry enough to pursue legal action. True regret, respect, and apologies are not panaceas, but they are important.25 Who gets sued and why is a key question that is part of a larger risk management plan. In this case, the magnitude of the injuries made a suit very likely, which is not the case with all bad outcomes.26 Honest communication with patients in the face of bad results remains the goal.27
Pulling it all together
Clinicians must always remain cognizant that the patient comes first and of the importance of working as a team with nursing staff and other allied health professionals. Excellent communication and support staff interaction in good times and bad can make a difference in patient outcomes and, indeed, in medical malpractice verdicts.
Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.
- Chang D. Miami doctor’s call to broker during baby’s delivery leads to $33.8 million judgment. Miami Herald. http://www.miamiherald.com/news/health-care/article147506019.html. Published April 28, 2017. Accessed May 16, 2018.
- Teller SE. $33.8 Million judgment reached in malpractice lawsuit. Legal Reader. https://www.legalreader.com/33-8-million-judgment-reached/. Published May 2017. Accessed May 16, 2018.
- Laska L. Medical Malpractice: Verdicts, Settlements, & Experts. 2017;33(11):17−18.
- Dixon v. U.S. Civil Action No. 15-23502-Civ-Scola. LEAGLE.com. https://www.leagle.com/decision/infdco20170501s18. Published April 28, 2017. Accessed May 8, 2018.
- American College of Obstetricians and Gynecologists Committee on Ethics. Committee Opinion No. 664: Refusal of medically recommended treatment during pregnancy. Obstet Gynecol. 2016;126(6):e175−e182.
- American College of Obstetricians and Gynecologists. Professional liability and risk management an essential guide for obstetrician-gynecologist. 3rd ed. Washington, DC: 2014.
- Ghidini A, Stewart D, Pezzullo J, Locatelli A. Neonatal complications in vacuum-assisted vaginal delivery: are they associated with number of pulls, cup detachments, and duration of vacuum application? Arch Gynecol Obstet. 2017;295(1):67−73.
- Turkmen S. Maternal and neonatal outcomes in vacuum-assisted delivery with the Kiwi OmniCup and Malmstrom metal cup. J Obstet Gynaecol Res. 2015;41(2):207−213.
- Davis DJ. Neonatal subgaleal hemorrhage: diagnosis and management. CMAJ. 2001;164(10):1452−1453.
- Chadwick LM, Pemberton PJ, Kurinczuk JJ. Neonatal subgaleal haematoma: associated risk factors, complications and outcome. J Paediatr Child Health. 1996;32(3):228−232.
- Dall’Asta A, Ghi T, Pedrazzi G, Frusca T. Does vacuum delivery carry a higher risk of shoulder dystocia? Review and metanalysis of the literature. Eur J Obstet Gynecol Reprod Biol. 2016;201:62−68.
- American College of Obstetricians and Gynecologists Task Force on Neonatal Encephalopathy. Neonatal Encephalopathy and Neurologic Outcomes. 2nd ed. Washington, DC: 2014.
- Nelson K, Ellenberg J. Apgar scores as predictors of chronic neurologic disability. Pediatrics. 1981;68:36−44.
- ACOG Technical Bulletin No. 163: Fetal and neonatal neurologic injury. Int J. Gynaecol Obstet. 1993;41(1):97−101.
- Nelson K, Ellenberg J. Antecedents of cerebral palsy. I. Univariate analysis of risks. Am J Dis Child. 1985;139(10):1031−1038.
- Fenichel GM, Webster D, Wong WK. Intracranial hemorrhage in the term newborn. Arch Neurol. 1984;41(1):30−34.
- Peckham C. Medscape Malpractice Report 2015: Why Ob/Gyns Get Sued. Medscape. https://www.medscape.com/features/slideshow/malpractice-report-2015/obgyn#page=1. Published January 2016. Accessed May 16, 2018.
- Bixenstine PJ, Shore AD, Mehtsun WT, Ibrahim AM, Freischlag JA, Makary MA. Catastrophic medical malpractice payouts in the United States. J Healthc Qual. 2014;36(4):43−53.
- Santos P, Ritter GA, Hefele JL, Hendrich A, McCoy CK. Decreasing intrapartum malpractice: Targeting the most injurious neonatal adverse events. J Healthc Risk Manag. 2015;34(4):20−27.
- Studdert DM, Bismark MM, Mello MM, Singh H, Spittal MJ. Prevalence and characteristics of physicians prone to malpractice claims. N Engl J Med. 2016;374(4):354−362.
- Levine AS. Legal 101: Tort law and medical malpractice for physicians. Contemp OBGYN. http://www.contem poraryobgyn.net/obstetrics-gynecology-womens-health/legal-101-tort-law-and-medical-malpractice-physicians. Published July 17, 2015. Accessed May 8, 2018.
- Smith SR, Sanfilippo JS. Applied Business Law. In: Sanfilippo JS, Bieber EJ, Javitch DG, Siegrist RB, eds. MBA for Healthcare. New York, NY: Oxford University Press; 2016:91−126.
- Glaser LM, Alvi FA, Milad MP. Trends in malpractice claims for obstetric and gynecologic procedures, 2005 through 2014. Am J Obstet Gynecol. 2017;217(3):340.e1–e6.
- Seegert L. Malpractice pitfalls: 5 strategies to reduce lawsuit threats. Medical Econ. http://www.medicaleconomics.com/medical-economics-blog/5-strategies-reduce-malpractice-lawsuit-threats. Published November 10, 2016. Accessed May 8, 2018.
- Peckham C. Malpractice and medicine: who gets sued and why? Medscape. http://www.medscape.com/viewarticle/855229. Published December 8, 2015. Accessed May 16, 2018.
- McMichael B. The failure of ‘sorry’: an empirical evaluation of apology laws, health care, and medical malpractice. Social Science Research Network. https://papers.ssrn.com/abstract=3020352. Published August 16, 2017. Accessed May 16, 2018.
- Carranza L, Lyerly AD, Lipira L, Prouty CD, Loren D, Gallagher TH. Delivering the truth: challenges and opportunities for error disclosure in obstetrics. Obstet Gynecol. 2014;123(3):656−659.
In this quarterly column, these medical and legal experts and educators present a case-based discussion and provide clear teaching points and takeaways for your practice.
Dr. Sanfilippo is Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, and Director, Reproductive Endocrinology and Infertility, at Magee-Womens Hospital, Pittsburgh, Pennsylvania. He also serves on the
Mr. Smith is Professor Emeritus and Dean Emeritus at California Western School of Law, San Diego, California.
The authors report no financial relationships relevant to this article.
In this quarterly column, these medical and legal experts and educators present a case-based discussion and provide clear teaching points and takeaways for your practice.
Dr. Sanfilippo is Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, and Director, Reproductive Endocrinology and Infertility, at Magee-Womens Hospital, Pittsburgh, Pennsylvania. He also serves on the
Mr. Smith is Professor Emeritus and Dean Emeritus at California Western School of Law, San Diego, California.
The authors report no financial relationships relevant to this article.
In this quarterly column, these medical and legal experts and educators present a case-based discussion and provide clear teaching points and takeaways for your practice.
Dr. Sanfilippo is Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, and Director, Reproductive Endocrinology and Infertility, at Magee-Womens Hospital, Pittsburgh, Pennsylvania. He also serves on the
Mr. Smith is Professor Emeritus and Dean Emeritus at California Western School of Law, San Diego, California.
The authors report no financial relationships relevant to this article.
CASE Failure to perform cesarean delivery1–4
A 19-year-old woman (G1P0) received prenatal care at a federally funded health center. Her pregnancy was normal without complications. She presented to the hospital after spontaneous rupture of membranes (SROM). The on-call ObGyn employed by the clinic was offsite when the mother was admitted.
The mother signed a standard consent form for vaginal and cesarean deliveries and any other surgical procedure required during the course of giving birth.
The ObGyn ordered low-dose oxytocin to augment labor in light of her SROM. Oxytocin was started at 9:46
Upon delivery, the infant was flaccid and not breathing. His Apgar scores were 2, 3, and 6 at 1, 5, and 10 minutes, respectively, and the cord pH was 7. The neonatal intensive care (NICU) team provided aggressive resuscitation.
At the time of trial, the 18-month-old boy was being fed through a percutaneous endoscopic gastrostomy tube and had a tracheostomy that required periodic suctioning. The child was not able to stand, crawl, or support himself, and will require 24-hour nursing care for the rest of his life.
LAWSUIT. The parents filed a lawsuit in federal court for damages under the Federal Tort Claims Act (see “Notes about this case,”). The mother claimed that she had requested a cesarean delivery early in labor when FHR tracings showed fetal distress, and again prior to vacuum extraction; the ObGyn refused both times.
The ObGyn claimed that when he noted a category III tracing, he recommended cesarean delivery, but the patient refused. He recorded the refusal in the chart some time later, after he had noted the neonate’s appearance.
The parents’ expert testified that restarting oxytocin and using vacuum extraction multiple times were dangerous and gross deviations from acceptable practice. Prolonged and repetitive use of the vacuum extractor caused a large subgaleal hematoma that decreased blood flow to the fetal brain, resulting in irreversible central nervous system (CNS) damage secondary to hypoxic ischemic encephalopathy. An emergency cesarean delivery should have been performed at the first sign of fetal distress.
The defense expert pointed out that the ObGyn discussed the need for cesarean delivery with the patient when fetal distress occurred and that the ObGyn was bedside and monitoring the fetus and the mother. Although the mother consented to a cesarean delivery at time of admission, she refused to allow the procedure.
The labor and delivery (L&D) nurse corroborated the mother’s story that a cesarean delivery was not offered by the ObGyn, and when the patient asked for a cesarean delivery, he refused. The nurse stated that the note added to the records by the ObGyn about the mother’s refusal was a lie. If the mother had refused a cesarean, the nurse would have documented the refusal by completing a Refusal of Treatment form that would have been faxed to the risk manager. No such form was required because nothing was ever offered that the mother refused.
The nurse also testified that during the course of the latter part of labor, the ObGyn left the room several times to assist other patients, deliver another baby, and make an 8-minute phone call to his stockbroker. She reported that the ObGyn was out of the room when delivery occurred.
WHAT’S THE VERDICT?
Read about the verdict and medical considerations.
WHAT’S THE VERDICT?
The medical care and the federal-court bench trial held in front of a judge (not a jury) occurred in Florida. The verdict suggests that the ObGyn breached the standard of care by not offering or proceeding with a cesarean delivery and this management resulted in the child’s injuries. The court awarded damages in the amount of $33,813,495.91, including $29,413,495.91 for the infant; $3,300,000.00 for the plaintiff; and $1,100,000.00 for her spouse.4
Medical considerations
Refusal of medical care
Although it appears that in this case the patient did not actually refuse medical care (cesarean delivery), the case does raise the question of refusal. Refusal of medical care has been addressed by the American College of Obstetricians and Gynecologists (ACOG) predicated upon care that supports maternal and fetal wellbeing.5 There may be a fine balance between safeguarding the pregnant woman’s autonomy and optimization of fetal wellbeing. “Forced compliance,” on the other hand, is the alternative to respecting refusal of treatment. Ethical issues come into play: patient rights; respect for autonomy; violations of bodily integrity; power differentials; and gender equality.5 The use of coercion is “not only ethically impermissible but also medically inadvisable secondary to the realities of prognostic uncertainty and the limitations of medical knowledge.”5 There is an obligation to elicit the patient’s reasoning and lived experience. Perhaps most importantly, as clinicians working to achieve a resolution, consideration of the following is appropriate5:
- reliability and validity of evidence-based medicine
- severity of the prospective outcome
- degree of risk or burden placed on the patient
- patient understanding of the gravity of the situation and risks
- degree of urgency.
Much of this boils down to the obligation to discuss “risks and benefits of treatment, alternatives and consequences of refusing treatment.”6
Complications from vacuum-assisted vaginal delivery
Ghidini and associates, in a multicenter retrospective study, evaluated complications relating to vacuum-assisted delivery. They listed major primary outcomes of subgaleal hemorrhage, skull fracture, and intracranial bleeding, and minor primary outcomes of cephalohematoma, scalp laceration, and extensive skin abrasions. Secondary outcomes included a 5-minute Apgar score of <7, umbilical artery pH of <7.10, shoulder dystocia, and NICU admission.7
A retrospective study from Sweden assessing all vacuum deliveries over a 2-year period compared the use of the Kiwi OmniCup (Clinical Innovations) to use of the Malmström metal cup (Medela). No statistical differences in maternal or neonatal outcomes as well as failure rates were noted. However, the duration of the procedure was longer and the requirement for fundal pressure was higher with the Malmström device.8
Subgaleal hemorrhage. Ghidini and colleagues reported a heightened incidence of head injury related to the duration of vacuum application and birth weight.7 Specifically, vacuum delivery devices increase the risk of subgaleal hemorrhage. Blood can accumulate between the scalp’s epicranial aponeurosis and the periosteum and potentially can extend forward to the orbital margins, backward to the nuchal ridge, and laterally to the temporal fascia. As much as 260 mL of blood can get into this subaponeurotic space in term babies.9 Up to one-quarter of babies who require NICU admission for this condition die.10 This injury seldom occurs with forceps.
Shoulder dystocia. In a meta-analysisfrom Italy, the vacuum extractor was associated with increased risk of shoulder dystocia compared with spontaneous vaginal delivery.11
Intrapartum hypoxia. In 2003, the ACOG Task Force on Neonatal Encephalopathy and Cerebral Palsy defined an acute intrapartum hypoxic event (TABLE).12
Cerebral palsy (CP) is defined as “a chronic neuromuscular disability characterized by aberrant control of movement or posture appearing early in life and not the result of recognized progressive disease.”13,14
The Collaborative Perinatal Project concluded that birth trauma plays a minimal role in development of CP.15 Arrested labor, use of oxytocin, or prolonged labor did not play a role. CP can develop following significant cerebral or posterior fossa hemorrhage in term infants.16
Perinatal asphyxia is a poor and imprecise term and use of the expression should be abandoned. Overall, 90% of children with CP do not have birth asphyxia as the underlying etiology.14
Prognostic assessment can be made, in part, by using the Sarnat classification system (classification scale for hypoxic-ischemic encephalopathy of the newborn) or an electroencephalogram to stratify the severity of neonatal encephalopathy.12 Such tests are not stand-alone but a segment of assessment. At this point “a better understanding of the processes leading to neonatal encephalopathy and associated outcomes” appear to be required to understand and associate outcomes.12 “More accurate and reliable tools (are required) for prognostic forecasting.”12
Hypoxic-ischemic encephalopathy involves multisystem organ failure including renal, hepatic, hematologic, cardiac, gastrointestinal, and metabolic abnormalities. There is no correlation between the degree of CNS injury and level of other organ abnormalities.12
Differential diagnosis
When events such as those described in this case occur, develop a differential diagnosis by considering the following12:
- uterine rupture
- severe placental abruption
- umbilical cord prolapse
- amniotic fluid embolus
- maternal cardiovascular collapse
- fetal exsanguination.
Read about the legal considerations.
Legal considerations
Although ObGyns are among the specialties most likely to experience malpractice claims,17 a verdict of more than $33 million is unusual.18 Despite the failure of adequate care, and the enormous damages, the ObGyn involved probably will not be responsible for paying the verdict (see “Notes about this case”). The case presents a number of important lessons and reminders for anyone practicing obstetrics.
A procedural comment
The case in this article arose under the Federal Tort Claims Act (FTCA).1 Most government entities have sovereign immunity, meaning that they can be sued only with their consent. In the FTCA, the federal government consented to being sued for the acts of its employees. This right has a number of limitations and some technical procedures, but at its core, it permits the United States to be sued as though it was a private individual.2 Private individuals can be sued for the acts of the agents (including employees).
Although the FTCA is a federal law, and these cases are tried in federal court, the substantive law of the state applies. This case occurred in Florida, so Florida tort law, defenses, and limitation on claims applied here also. Had the events occurred in Iowa, Iowa law would have applied.
In FTCA cases, the United States is the defendant (generally it is the government, not the employee who is the defendant).3 In this case, the ObGyn was employed by a federal government entity to provide delivery services. As a result, the United States was the primary defendant, had the obligation to defend the suit, and will almost certainly be obligated to pay the verdict.
The case facts
Although this description is based on an actual case, the facts were taken from the opinion of the trial court, legal summaries and press reports and not from the full case documents.4-7 We could not independently assess the accuracy of the facts, but for the purpose of this discussion, we have assumed the facts to be correct. The government has apparently filed an appeal in the Eleventh Circuit.
References
- Federal Tort Claims Act. Vol 28 U.S.C. Pt.VI Ch.171 and 28 U.S.C. § 1346(b).
- About the Federal Tort Claims Act (FTCA). Health Resources & Services Administration: Health Center Program. https://bphc.hrsa.gov/ftca/about/index.html. Accessed May 16, 2018.
- Dowell MA, Scott CD. Federally Qualified Health Center Federal Tort Claims Act Insurance Coverage. Health Law. 2015;5:31-43.
- Chang D. Miami doctor's call to broker during baby's delivery leads to $33.8 million judgment. Miami Herald. http://www.miamiherald.com/news/health-care/article147506019.html. Published April 28, 2017. Accessed January 11, 2018.
- Teller SE. $33.8 Million judgment reached in malpractice lawsuit. Legal Reader. https://www.legalreader.com/33-8-million-judgment-reached/. Published May 2017. Accessed May 16, 2018.
- Laska L. Medical Malpractice: Verdicts, Settlements, & Experts. 2017;33(11):17-18.
- Dixon v. U.S. Civil Action No. 15-23502-Civ-Scola. LEAGLE.com. https://www.leagle.com/decision/infdco20170501s18. Published April 28, 2017. Accessed May 8, 2018.
Very large verdict
The extraordinary size of this verdict ($33 million without any punitive damages) is a reminder that in obstetrics, mistakes can have catastrophic consequences and very high costs.19 This fact is reflected in malpractice insurance rates.
A substantial amount of this case’s award will provide around-the-clock care for the child. This verdict was not the result of a runaway jury—it was a judge’s decision. It is also noteworthy to report that a small percentage of physicians (1%) appear responsible for a significant number (about one-third) of paid claims.20
Although the size of the verdict is unusual, the case is a fairly straightforward negligence tort. The judge found that the ObGyn had breached the duty of care for his patient. The actions that fell below the standard of care included restarting the oxytocin, using the Kiwi vacuum device 3 times, and failing to perform a cesarean delivery in light of obvious fetal distress. That negligence caused injury to the infant (and his parents).21 The judge determined that the 4 elements of negligence were present: 1) duty of care, 2) breach of that duty, 3) injury, and 4) a causal link between the breach of duty and the injury. The failure to adhere to good practice standards practically defines breach of duty.22
Multitasking
One important lesson is that multitasking, absence, and inattention can look terrible when things go wrong. Known as “hindsight bias,” the awareness that there was a disastrous result makes it easier to attribute the outcome to small mistakes that otherwise might seem trivial. This ObGyn was in and out of the room during a difficult labor. Perhaps that was understandable if it were unavoidable because of another delivery, but being absent frequently and not present for the delivery now looks very significant.23 And, of course, the 8-minute phone call to the stockbroker shines as a heartless, self-centered act of inattention.
Manipulating the record
Another lesson of this case: Do not manipulate the record. The ObGyn recorded that the patient had refused the cesarean delivery he recommended. Had that been the truth, it would have substantially improved his case. But apparently it was not the truth. Although there was circumstantial evidence (the charting of the patient’s refusal only after the newborn’s condition was obvious, failure to complete appropriate hospital forms), the most damning evidence was the direct testimony of the L&D nurse. She reported that, contrary to what the ObGyn put in the chart, the patient requested a cesarean delivery. In truth, it was the ObGyn who had refused.
A physician who is dishonest with charting—making false statements or going back or “correcting” a chart later—loses credibility and the presumption of acting in good faith. That is disastrous for the physician.24
A hidden lesson
Another lesson, more human than legal, is that it matters how patients are treated when things go wrong. According to press reports, the parents felt that the ObGyn had not recognized that he had made any errors, did not apologize, and had even blamed the mother for the outcome. It does not require graduate work in psychology to expect that this approach would make the parents angry enough to pursue legal action. True regret, respect, and apologies are not panaceas, but they are important.25 Who gets sued and why is a key question that is part of a larger risk management plan. In this case, the magnitude of the injuries made a suit very likely, which is not the case with all bad outcomes.26 Honest communication with patients in the face of bad results remains the goal.27
Pulling it all together
Clinicians must always remain cognizant that the patient comes first and of the importance of working as a team with nursing staff and other allied health professionals. Excellent communication and support staff interaction in good times and bad can make a difference in patient outcomes and, indeed, in medical malpractice verdicts.
Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.
CASE Failure to perform cesarean delivery1–4
A 19-year-old woman (G1P0) received prenatal care at a federally funded health center. Her pregnancy was normal without complications. She presented to the hospital after spontaneous rupture of membranes (SROM). The on-call ObGyn employed by the clinic was offsite when the mother was admitted.
The mother signed a standard consent form for vaginal and cesarean deliveries and any other surgical procedure required during the course of giving birth.
The ObGyn ordered low-dose oxytocin to augment labor in light of her SROM. Oxytocin was started at 9:46
Upon delivery, the infant was flaccid and not breathing. His Apgar scores were 2, 3, and 6 at 1, 5, and 10 minutes, respectively, and the cord pH was 7. The neonatal intensive care (NICU) team provided aggressive resuscitation.
At the time of trial, the 18-month-old boy was being fed through a percutaneous endoscopic gastrostomy tube and had a tracheostomy that required periodic suctioning. The child was not able to stand, crawl, or support himself, and will require 24-hour nursing care for the rest of his life.
LAWSUIT. The parents filed a lawsuit in federal court for damages under the Federal Tort Claims Act (see “Notes about this case,”). The mother claimed that she had requested a cesarean delivery early in labor when FHR tracings showed fetal distress, and again prior to vacuum extraction; the ObGyn refused both times.
The ObGyn claimed that when he noted a category III tracing, he recommended cesarean delivery, but the patient refused. He recorded the refusal in the chart some time later, after he had noted the neonate’s appearance.
The parents’ expert testified that restarting oxytocin and using vacuum extraction multiple times were dangerous and gross deviations from acceptable practice. Prolonged and repetitive use of the vacuum extractor caused a large subgaleal hematoma that decreased blood flow to the fetal brain, resulting in irreversible central nervous system (CNS) damage secondary to hypoxic ischemic encephalopathy. An emergency cesarean delivery should have been performed at the first sign of fetal distress.
The defense expert pointed out that the ObGyn discussed the need for cesarean delivery with the patient when fetal distress occurred and that the ObGyn was bedside and monitoring the fetus and the mother. Although the mother consented to a cesarean delivery at time of admission, she refused to allow the procedure.
The labor and delivery (L&D) nurse corroborated the mother’s story that a cesarean delivery was not offered by the ObGyn, and when the patient asked for a cesarean delivery, he refused. The nurse stated that the note added to the records by the ObGyn about the mother’s refusal was a lie. If the mother had refused a cesarean, the nurse would have documented the refusal by completing a Refusal of Treatment form that would have been faxed to the risk manager. No such form was required because nothing was ever offered that the mother refused.
The nurse also testified that during the course of the latter part of labor, the ObGyn left the room several times to assist other patients, deliver another baby, and make an 8-minute phone call to his stockbroker. She reported that the ObGyn was out of the room when delivery occurred.
WHAT’S THE VERDICT?
Read about the verdict and medical considerations.
WHAT’S THE VERDICT?
The medical care and the federal-court bench trial held in front of a judge (not a jury) occurred in Florida. The verdict suggests that the ObGyn breached the standard of care by not offering or proceeding with a cesarean delivery and this management resulted in the child’s injuries. The court awarded damages in the amount of $33,813,495.91, including $29,413,495.91 for the infant; $3,300,000.00 for the plaintiff; and $1,100,000.00 for her spouse.4
Medical considerations
Refusal of medical care
Although it appears that in this case the patient did not actually refuse medical care (cesarean delivery), the case does raise the question of refusal. Refusal of medical care has been addressed by the American College of Obstetricians and Gynecologists (ACOG) predicated upon care that supports maternal and fetal wellbeing.5 There may be a fine balance between safeguarding the pregnant woman’s autonomy and optimization of fetal wellbeing. “Forced compliance,” on the other hand, is the alternative to respecting refusal of treatment. Ethical issues come into play: patient rights; respect for autonomy; violations of bodily integrity; power differentials; and gender equality.5 The use of coercion is “not only ethically impermissible but also medically inadvisable secondary to the realities of prognostic uncertainty and the limitations of medical knowledge.”5 There is an obligation to elicit the patient’s reasoning and lived experience. Perhaps most importantly, as clinicians working to achieve a resolution, consideration of the following is appropriate5:
- reliability and validity of evidence-based medicine
- severity of the prospective outcome
- degree of risk or burden placed on the patient
- patient understanding of the gravity of the situation and risks
- degree of urgency.
Much of this boils down to the obligation to discuss “risks and benefits of treatment, alternatives and consequences of refusing treatment.”6
Complications from vacuum-assisted vaginal delivery
Ghidini and associates, in a multicenter retrospective study, evaluated complications relating to vacuum-assisted delivery. They listed major primary outcomes of subgaleal hemorrhage, skull fracture, and intracranial bleeding, and minor primary outcomes of cephalohematoma, scalp laceration, and extensive skin abrasions. Secondary outcomes included a 5-minute Apgar score of <7, umbilical artery pH of <7.10, shoulder dystocia, and NICU admission.7
A retrospective study from Sweden assessing all vacuum deliveries over a 2-year period compared the use of the Kiwi OmniCup (Clinical Innovations) to use of the Malmström metal cup (Medela). No statistical differences in maternal or neonatal outcomes as well as failure rates were noted. However, the duration of the procedure was longer and the requirement for fundal pressure was higher with the Malmström device.8
Subgaleal hemorrhage. Ghidini and colleagues reported a heightened incidence of head injury related to the duration of vacuum application and birth weight.7 Specifically, vacuum delivery devices increase the risk of subgaleal hemorrhage. Blood can accumulate between the scalp’s epicranial aponeurosis and the periosteum and potentially can extend forward to the orbital margins, backward to the nuchal ridge, and laterally to the temporal fascia. As much as 260 mL of blood can get into this subaponeurotic space in term babies.9 Up to one-quarter of babies who require NICU admission for this condition die.10 This injury seldom occurs with forceps.
Shoulder dystocia. In a meta-analysisfrom Italy, the vacuum extractor was associated with increased risk of shoulder dystocia compared with spontaneous vaginal delivery.11
Intrapartum hypoxia. In 2003, the ACOG Task Force on Neonatal Encephalopathy and Cerebral Palsy defined an acute intrapartum hypoxic event (TABLE).12
Cerebral palsy (CP) is defined as “a chronic neuromuscular disability characterized by aberrant control of movement or posture appearing early in life and not the result of recognized progressive disease.”13,14
The Collaborative Perinatal Project concluded that birth trauma plays a minimal role in development of CP.15 Arrested labor, use of oxytocin, or prolonged labor did not play a role. CP can develop following significant cerebral or posterior fossa hemorrhage in term infants.16
Perinatal asphyxia is a poor and imprecise term and use of the expression should be abandoned. Overall, 90% of children with CP do not have birth asphyxia as the underlying etiology.14
Prognostic assessment can be made, in part, by using the Sarnat classification system (classification scale for hypoxic-ischemic encephalopathy of the newborn) or an electroencephalogram to stratify the severity of neonatal encephalopathy.12 Such tests are not stand-alone but a segment of assessment. At this point “a better understanding of the processes leading to neonatal encephalopathy and associated outcomes” appear to be required to understand and associate outcomes.12 “More accurate and reliable tools (are required) for prognostic forecasting.”12
Hypoxic-ischemic encephalopathy involves multisystem organ failure including renal, hepatic, hematologic, cardiac, gastrointestinal, and metabolic abnormalities. There is no correlation between the degree of CNS injury and level of other organ abnormalities.12
Differential diagnosis
When events such as those described in this case occur, develop a differential diagnosis by considering the following12:
- uterine rupture
- severe placental abruption
- umbilical cord prolapse
- amniotic fluid embolus
- maternal cardiovascular collapse
- fetal exsanguination.
Read about the legal considerations.
Legal considerations
Although ObGyns are among the specialties most likely to experience malpractice claims,17 a verdict of more than $33 million is unusual.18 Despite the failure of adequate care, and the enormous damages, the ObGyn involved probably will not be responsible for paying the verdict (see “Notes about this case”). The case presents a number of important lessons and reminders for anyone practicing obstetrics.
A procedural comment
The case in this article arose under the Federal Tort Claims Act (FTCA).1 Most government entities have sovereign immunity, meaning that they can be sued only with their consent. In the FTCA, the federal government consented to being sued for the acts of its employees. This right has a number of limitations and some technical procedures, but at its core, it permits the United States to be sued as though it was a private individual.2 Private individuals can be sued for the acts of the agents (including employees).
Although the FTCA is a federal law, and these cases are tried in federal court, the substantive law of the state applies. This case occurred in Florida, so Florida tort law, defenses, and limitation on claims applied here also. Had the events occurred in Iowa, Iowa law would have applied.
In FTCA cases, the United States is the defendant (generally it is the government, not the employee who is the defendant).3 In this case, the ObGyn was employed by a federal government entity to provide delivery services. As a result, the United States was the primary defendant, had the obligation to defend the suit, and will almost certainly be obligated to pay the verdict.
The case facts
Although this description is based on an actual case, the facts were taken from the opinion of the trial court, legal summaries and press reports and not from the full case documents.4-7 We could not independently assess the accuracy of the facts, but for the purpose of this discussion, we have assumed the facts to be correct. The government has apparently filed an appeal in the Eleventh Circuit.
References
- Federal Tort Claims Act. Vol 28 U.S.C. Pt.VI Ch.171 and 28 U.S.C. § 1346(b).
- About the Federal Tort Claims Act (FTCA). Health Resources & Services Administration: Health Center Program. https://bphc.hrsa.gov/ftca/about/index.html. Accessed May 16, 2018.
- Dowell MA, Scott CD. Federally Qualified Health Center Federal Tort Claims Act Insurance Coverage. Health Law. 2015;5:31-43.
- Chang D. Miami doctor's call to broker during baby's delivery leads to $33.8 million judgment. Miami Herald. http://www.miamiherald.com/news/health-care/article147506019.html. Published April 28, 2017. Accessed January 11, 2018.
- Teller SE. $33.8 Million judgment reached in malpractice lawsuit. Legal Reader. https://www.legalreader.com/33-8-million-judgment-reached/. Published May 2017. Accessed May 16, 2018.
- Laska L. Medical Malpractice: Verdicts, Settlements, & Experts. 2017;33(11):17-18.
- Dixon v. U.S. Civil Action No. 15-23502-Civ-Scola. LEAGLE.com. https://www.leagle.com/decision/infdco20170501s18. Published April 28, 2017. Accessed May 8, 2018.
Very large verdict
The extraordinary size of this verdict ($33 million without any punitive damages) is a reminder that in obstetrics, mistakes can have catastrophic consequences and very high costs.19 This fact is reflected in malpractice insurance rates.
A substantial amount of this case’s award will provide around-the-clock care for the child. This verdict was not the result of a runaway jury—it was a judge’s decision. It is also noteworthy to report that a small percentage of physicians (1%) appear responsible for a significant number (about one-third) of paid claims.20
Although the size of the verdict is unusual, the case is a fairly straightforward negligence tort. The judge found that the ObGyn had breached the duty of care for his patient. The actions that fell below the standard of care included restarting the oxytocin, using the Kiwi vacuum device 3 times, and failing to perform a cesarean delivery in light of obvious fetal distress. That negligence caused injury to the infant (and his parents).21 The judge determined that the 4 elements of negligence were present: 1) duty of care, 2) breach of that duty, 3) injury, and 4) a causal link between the breach of duty and the injury. The failure to adhere to good practice standards practically defines breach of duty.22
Multitasking
One important lesson is that multitasking, absence, and inattention can look terrible when things go wrong. Known as “hindsight bias,” the awareness that there was a disastrous result makes it easier to attribute the outcome to small mistakes that otherwise might seem trivial. This ObGyn was in and out of the room during a difficult labor. Perhaps that was understandable if it were unavoidable because of another delivery, but being absent frequently and not present for the delivery now looks very significant.23 And, of course, the 8-minute phone call to the stockbroker shines as a heartless, self-centered act of inattention.
Manipulating the record
Another lesson of this case: Do not manipulate the record. The ObGyn recorded that the patient had refused the cesarean delivery he recommended. Had that been the truth, it would have substantially improved his case. But apparently it was not the truth. Although there was circumstantial evidence (the charting of the patient’s refusal only after the newborn’s condition was obvious, failure to complete appropriate hospital forms), the most damning evidence was the direct testimony of the L&D nurse. She reported that, contrary to what the ObGyn put in the chart, the patient requested a cesarean delivery. In truth, it was the ObGyn who had refused.
A physician who is dishonest with charting—making false statements or going back or “correcting” a chart later—loses credibility and the presumption of acting in good faith. That is disastrous for the physician.24
A hidden lesson
Another lesson, more human than legal, is that it matters how patients are treated when things go wrong. According to press reports, the parents felt that the ObGyn had not recognized that he had made any errors, did not apologize, and had even blamed the mother for the outcome. It does not require graduate work in psychology to expect that this approach would make the parents angry enough to pursue legal action. True regret, respect, and apologies are not panaceas, but they are important.25 Who gets sued and why is a key question that is part of a larger risk management plan. In this case, the magnitude of the injuries made a suit very likely, which is not the case with all bad outcomes.26 Honest communication with patients in the face of bad results remains the goal.27
Pulling it all together
Clinicians must always remain cognizant that the patient comes first and of the importance of working as a team with nursing staff and other allied health professionals. Excellent communication and support staff interaction in good times and bad can make a difference in patient outcomes and, indeed, in medical malpractice verdicts.
Share your thoughts! Send your Letter to the Editor to rbarbieri@mdedge.com. Please include your name and the city and state in which you practice.
- Chang D. Miami doctor’s call to broker during baby’s delivery leads to $33.8 million judgment. Miami Herald. http://www.miamiherald.com/news/health-care/article147506019.html. Published April 28, 2017. Accessed May 16, 2018.
- Teller SE. $33.8 Million judgment reached in malpractice lawsuit. Legal Reader. https://www.legalreader.com/33-8-million-judgment-reached/. Published May 2017. Accessed May 16, 2018.
- Laska L. Medical Malpractice: Verdicts, Settlements, & Experts. 2017;33(11):17−18.
- Dixon v. U.S. Civil Action No. 15-23502-Civ-Scola. LEAGLE.com. https://www.leagle.com/decision/infdco20170501s18. Published April 28, 2017. Accessed May 8, 2018.
- American College of Obstetricians and Gynecologists Committee on Ethics. Committee Opinion No. 664: Refusal of medically recommended treatment during pregnancy. Obstet Gynecol. 2016;126(6):e175−e182.
- American College of Obstetricians and Gynecologists. Professional liability and risk management an essential guide for obstetrician-gynecologist. 3rd ed. Washington, DC: 2014.
- Ghidini A, Stewart D, Pezzullo J, Locatelli A. Neonatal complications in vacuum-assisted vaginal delivery: are they associated with number of pulls, cup detachments, and duration of vacuum application? Arch Gynecol Obstet. 2017;295(1):67−73.
- Turkmen S. Maternal and neonatal outcomes in vacuum-assisted delivery with the Kiwi OmniCup and Malmstrom metal cup. J Obstet Gynaecol Res. 2015;41(2):207−213.
- Davis DJ. Neonatal subgaleal hemorrhage: diagnosis and management. CMAJ. 2001;164(10):1452−1453.
- Chadwick LM, Pemberton PJ, Kurinczuk JJ. Neonatal subgaleal haematoma: associated risk factors, complications and outcome. J Paediatr Child Health. 1996;32(3):228−232.
- Dall’Asta A, Ghi T, Pedrazzi G, Frusca T. Does vacuum delivery carry a higher risk of shoulder dystocia? Review and metanalysis of the literature. Eur J Obstet Gynecol Reprod Biol. 2016;201:62−68.
- American College of Obstetricians and Gynecologists Task Force on Neonatal Encephalopathy. Neonatal Encephalopathy and Neurologic Outcomes. 2nd ed. Washington, DC: 2014.
- Nelson K, Ellenberg J. Apgar scores as predictors of chronic neurologic disability. Pediatrics. 1981;68:36−44.
- ACOG Technical Bulletin No. 163: Fetal and neonatal neurologic injury. Int J. Gynaecol Obstet. 1993;41(1):97−101.
- Nelson K, Ellenberg J. Antecedents of cerebral palsy. I. Univariate analysis of risks. Am J Dis Child. 1985;139(10):1031−1038.
- Fenichel GM, Webster D, Wong WK. Intracranial hemorrhage in the term newborn. Arch Neurol. 1984;41(1):30−34.
- Peckham C. Medscape Malpractice Report 2015: Why Ob/Gyns Get Sued. Medscape. https://www.medscape.com/features/slideshow/malpractice-report-2015/obgyn#page=1. Published January 2016. Accessed May 16, 2018.
- Bixenstine PJ, Shore AD, Mehtsun WT, Ibrahim AM, Freischlag JA, Makary MA. Catastrophic medical malpractice payouts in the United States. J Healthc Qual. 2014;36(4):43−53.
- Santos P, Ritter GA, Hefele JL, Hendrich A, McCoy CK. Decreasing intrapartum malpractice: Targeting the most injurious neonatal adverse events. J Healthc Risk Manag. 2015;34(4):20−27.
- Studdert DM, Bismark MM, Mello MM, Singh H, Spittal MJ. Prevalence and characteristics of physicians prone to malpractice claims. N Engl J Med. 2016;374(4):354−362.
- Levine AS. Legal 101: Tort law and medical malpractice for physicians. Contemp OBGYN. http://www.contem poraryobgyn.net/obstetrics-gynecology-womens-health/legal-101-tort-law-and-medical-malpractice-physicians. Published July 17, 2015. Accessed May 8, 2018.
- Smith SR, Sanfilippo JS. Applied Business Law. In: Sanfilippo JS, Bieber EJ, Javitch DG, Siegrist RB, eds. MBA for Healthcare. New York, NY: Oxford University Press; 2016:91−126.
- Glaser LM, Alvi FA, Milad MP. Trends in malpractice claims for obstetric and gynecologic procedures, 2005 through 2014. Am J Obstet Gynecol. 2017;217(3):340.e1–e6.
- Seegert L. Malpractice pitfalls: 5 strategies to reduce lawsuit threats. Medical Econ. http://www.medicaleconomics.com/medical-economics-blog/5-strategies-reduce-malpractice-lawsuit-threats. Published November 10, 2016. Accessed May 8, 2018.
- Peckham C. Malpractice and medicine: who gets sued and why? Medscape. http://www.medscape.com/viewarticle/855229. Published December 8, 2015. Accessed May 16, 2018.
- McMichael B. The failure of ‘sorry’: an empirical evaluation of apology laws, health care, and medical malpractice. Social Science Research Network. https://papers.ssrn.com/abstract=3020352. Published August 16, 2017. Accessed May 16, 2018.
- Carranza L, Lyerly AD, Lipira L, Prouty CD, Loren D, Gallagher TH. Delivering the truth: challenges and opportunities for error disclosure in obstetrics. Obstet Gynecol. 2014;123(3):656−659.
- Chang D. Miami doctor’s call to broker during baby’s delivery leads to $33.8 million judgment. Miami Herald. http://www.miamiherald.com/news/health-care/article147506019.html. Published April 28, 2017. Accessed May 16, 2018.
- Teller SE. $33.8 Million judgment reached in malpractice lawsuit. Legal Reader. https://www.legalreader.com/33-8-million-judgment-reached/. Published May 2017. Accessed May 16, 2018.
- Laska L. Medical Malpractice: Verdicts, Settlements, & Experts. 2017;33(11):17−18.
- Dixon v. U.S. Civil Action No. 15-23502-Civ-Scola. LEAGLE.com. https://www.leagle.com/decision/infdco20170501s18. Published April 28, 2017. Accessed May 8, 2018.
- American College of Obstetricians and Gynecologists Committee on Ethics. Committee Opinion No. 664: Refusal of medically recommended treatment during pregnancy. Obstet Gynecol. 2016;126(6):e175−e182.
- American College of Obstetricians and Gynecologists. Professional liability and risk management an essential guide for obstetrician-gynecologist. 3rd ed. Washington, DC: 2014.
- Ghidini A, Stewart D, Pezzullo J, Locatelli A. Neonatal complications in vacuum-assisted vaginal delivery: are they associated with number of pulls, cup detachments, and duration of vacuum application? Arch Gynecol Obstet. 2017;295(1):67−73.
- Turkmen S. Maternal and neonatal outcomes in vacuum-assisted delivery with the Kiwi OmniCup and Malmstrom metal cup. J Obstet Gynaecol Res. 2015;41(2):207−213.
- Davis DJ. Neonatal subgaleal hemorrhage: diagnosis and management. CMAJ. 2001;164(10):1452−1453.
- Chadwick LM, Pemberton PJ, Kurinczuk JJ. Neonatal subgaleal haematoma: associated risk factors, complications and outcome. J Paediatr Child Health. 1996;32(3):228−232.
- Dall’Asta A, Ghi T, Pedrazzi G, Frusca T. Does vacuum delivery carry a higher risk of shoulder dystocia? Review and metanalysis of the literature. Eur J Obstet Gynecol Reprod Biol. 2016;201:62−68.
- American College of Obstetricians and Gynecologists Task Force on Neonatal Encephalopathy. Neonatal Encephalopathy and Neurologic Outcomes. 2nd ed. Washington, DC: 2014.
- Nelson K, Ellenberg J. Apgar scores as predictors of chronic neurologic disability. Pediatrics. 1981;68:36−44.
- ACOG Technical Bulletin No. 163: Fetal and neonatal neurologic injury. Int J. Gynaecol Obstet. 1993;41(1):97−101.
- Nelson K, Ellenberg J. Antecedents of cerebral palsy. I. Univariate analysis of risks. Am J Dis Child. 1985;139(10):1031−1038.
- Fenichel GM, Webster D, Wong WK. Intracranial hemorrhage in the term newborn. Arch Neurol. 1984;41(1):30−34.
- Peckham C. Medscape Malpractice Report 2015: Why Ob/Gyns Get Sued. Medscape. https://www.medscape.com/features/slideshow/malpractice-report-2015/obgyn#page=1. Published January 2016. Accessed May 16, 2018.
- Bixenstine PJ, Shore AD, Mehtsun WT, Ibrahim AM, Freischlag JA, Makary MA. Catastrophic medical malpractice payouts in the United States. J Healthc Qual. 2014;36(4):43−53.
- Santos P, Ritter GA, Hefele JL, Hendrich A, McCoy CK. Decreasing intrapartum malpractice: Targeting the most injurious neonatal adverse events. J Healthc Risk Manag. 2015;34(4):20−27.
- Studdert DM, Bismark MM, Mello MM, Singh H, Spittal MJ. Prevalence and characteristics of physicians prone to malpractice claims. N Engl J Med. 2016;374(4):354−362.
- Levine AS. Legal 101: Tort law and medical malpractice for physicians. Contemp OBGYN. http://www.contem poraryobgyn.net/obstetrics-gynecology-womens-health/legal-101-tort-law-and-medical-malpractice-physicians. Published July 17, 2015. Accessed May 8, 2018.
- Smith SR, Sanfilippo JS. Applied Business Law. In: Sanfilippo JS, Bieber EJ, Javitch DG, Siegrist RB, eds. MBA for Healthcare. New York, NY: Oxford University Press; 2016:91−126.
- Glaser LM, Alvi FA, Milad MP. Trends in malpractice claims for obstetric and gynecologic procedures, 2005 through 2014. Am J Obstet Gynecol. 2017;217(3):340.e1–e6.
- Seegert L. Malpractice pitfalls: 5 strategies to reduce lawsuit threats. Medical Econ. http://www.medicaleconomics.com/medical-economics-blog/5-strategies-reduce-malpractice-lawsuit-threats. Published November 10, 2016. Accessed May 8, 2018.
- Peckham C. Malpractice and medicine: who gets sued and why? Medscape. http://www.medscape.com/viewarticle/855229. Published December 8, 2015. Accessed May 16, 2018.
- McMichael B. The failure of ‘sorry’: an empirical evaluation of apology laws, health care, and medical malpractice. Social Science Research Network. https://papers.ssrn.com/abstract=3020352. Published August 16, 2017. Accessed May 16, 2018.
- Carranza L, Lyerly AD, Lipira L, Prouty CD, Loren D, Gallagher TH. Delivering the truth: challenges and opportunities for error disclosure in obstetrics. Obstet Gynecol. 2014;123(3):656−659.
Interstitial Granulomatous Dermatitis and Palisaded Neutrophilic Granulomatous Dermatitis
To the Editor:
Palisaded neutrophilic granulomatous dermatitis (PNGD) is a rare disorder that often is associated with systemic disease. It has been shown to manifest in the presence of systemic lupus erythematosus; rheumatoid arthritis; Wegener granulomatosis; and other diseases, mainly autoimmune conditions. Interstitial granulomatous dermatitis (IGD) associated with arthritis was first described by Ackerman et al1 in 1993. In 1994, IGD was placed among the spectrum of PNGD by Chu et al.2 The disease entities included in the spectrum of PNGD of the immune complex disease are Churg-Strauss granuloma, cutaneous extravascular necrotizing granuloma, rheumatoid papules, superficial ulcerating rheumatoid necrobiosis, and IGD with arthritis.2 It has been suggested that IGD has a distinct clinical presentation with associated histopathology, while others suggest it still is part of the PNGD spectrum.2,3 We present 2 cases of granulomatous dermatitis and their findings related to IGD and PNGD.
A 58-year-old woman presented with recurrent painful lesions on the trunk, arms, and legs of 2 years’ duration. The lesions spontaneously resolved without scarring or hyperpigmentation but would recur in different areas on the trunk. She was diagnosed with rheumatoid arthritis following a recent autoimmune workup. At presentation, physical examination revealed tender erythematous edematous plaques on the bilateral upper back (Figure 1) and erythematous nodules on the bilateral upper arms. The patient previously had an antinuclear antibody titer of 1:320 with a speckled pattern. A repeat antinuclear antibody titer taken 1 year later was negative. Her rheumatoid factor initially was positive and remained positive upon repeat testing. Punch biopsies were performed for histologic evaluation of the lesions and immunofluorescence. Biopsies examined with hematoxylin and eosin stain revealed perivascular and interstitial mixed (lymphocytic, neutrophilic, eosinophilic) bottom-heavy inflammation with nuclear dust and basophilic degeneration of collagen (Figure 2). Immunofluorescence studies were negative. The patient deferred treatment.
A 74-year-old man presented with a rash on the flank and back with associated pruritus and occasional pain of 2 months’ duration. His primary care physician prescribed a course of cephalexin, but the rash did not improve. Review of systems was positive for intermittent swelling of the hands, feet, and lips, and negative for arthritis. His medical history included 2 episodes of rheumatic fever, one complicated by pneumonia. His medications included finasteride, simvastatin, bisoprolol-hydrochlorothiazide, aspirin, tiotropium, vitamin D, and fish oil. At presentation, physical examination revealed tender violaceous plaques with induration and central clearing distributed on the left side of the back, left side of the flank, and left axilla. The lesion on the axilla measured 30.0×3.5 cm and the lesions on the left side of the back measured 30.0×9.0 cm. The rims of the lesions were elevated and consistent with the rope sign (Figure 3). A punch biopsy of the lesion on the left axilla showed perivascular and interstitial infiltrate of lymphocytes, neutrophils, histiocytes, and eosinophils. There was no evidence of fibrin deposition in the blood vessels. Small areas of necrobiotic collagen surrounded by multinucleated giant cells and lymphocytes were noted (Figure 4). The rash improved spontaneously at the time of suture removal. No treatment was initiated.
Granulomatous dermatitis in the presence of an autoimmune disorder can present as IGD or PNGD. Both forms of granulomatous dermatitis are rare conditions and considered to be part of the same clinicopathological spectrum. These conditions can be difficult to distinguish clinically but are histologically unique.
Interstitial granulomatous dermatitis and PNGD can have a variable clinical expression. Palisaded neutrophilic granulomatous dermatitis generally presents as flesh-colored to erythematous papules or plaques, most commonly located on the upper arms. The lesions may have a central umbilication with perforation and ulceration.4 Interstitial granulomatous dermatitis most commonly presents as erythematous plaques and papules. The lesions are symmetric and asymptomatic. They most commonly appear on the trunk, axillae, buttocks, thighs, and groin. Subcutaneous linear cords (the rope sign) is a characteristic associated with IGD.3,5 However, the rope sign also has been reported in a patient with PNGD with systemic lupus,6 which further demonstrates the overlapping spectrum of clinical expression seen in these 2 forms of granulomatous dermatitis. Therefore, a diagnosis cannot be made by clinical expression alone; histologic findings are needed for confirmation.
When differentiating IGD and PNGD histologically, it is important to keep in mind that these features exist on a spectrum and depend on the age of the lesion. Deposition of the immune complex around the dermal blood vessel initiates the pathogenesis. Early lesions of PNGD show a neutrophilic infiltrate, focal leukocytoclastic vasculitis, and dense nuclear dust. Developed lesions show zones of basophilic degenerated collagen surrounded by palisades of histiocytes, neutrophils, and nuclear debris.2 The histologic pattern of IGD features smaller areas of palisading histiocytes surrounding foci of degenerated collagen. Neutrophils and eosinophils are seen among the degenerated collagen. There is no evidence of vasculitis and dermal mucin usually is absent.7
Palisaded neutrophilic granulomatous dermatitis has been reported to improve with systemic steroids and dapsone.8 Th
Some authors have disputed the spectrum that Chu et al2 had determined in their study and proposed IGD is a separate entity from the PNGD spectrum. Verneuil et al9 stated that the clinical presentations in Chu et al’s2 study (symmetric papules of the extremities) had not been reported in a patient with IGD. However, in a study of IGD by Peroni et al,3 7 of 12 patients presented with symmetrical papules of the extremities. We believe that the spectrum proposed by Chu et al2 still holds true.
These 2 reports demonstrate the diverse presentation of IGD and PNGD. It is important for dermatologists to keep in mind the PNGD spectrum when a patient presents with granulomatous dermatitis in the presence of an autoimmune disorder.
- Ackerman AB, Guo Y, Vitale P. Clues to diagnosis in dermatopathology. Am Society Clin Pathol. 1993;3:309-312.
- Chu P, Connolly MK, LeBoit PE. The histopathologic spectrum of palisaded neutrophilic and granulomatous dermatitis in patients with collagen vascular disease. Arch Dermatol. 1994;130:1278-1283.
- Peroni A, Colato C, Schena D, et al. Interstitial granulomatous dermatitis: a distinct entity with characteristic histological and clinical pattern. Br J Dermatol. 2012;166:775-783.
- Hantash BM, Chiang D, Kohler S, et al. Palisaded neutrophilic and granulomatous dermatitis associated with limited systemic sclerosis. J Am Acad Dermatol. 2008;58:661-664.
- Garcia-Rabasco A, Esteve-Martinez A, Zaragoza-Ninet V, et al. Interstitial granulomatous dermatitis in a patient with lupus erythematosus. Am J Dermatopathol. 2011;33:871-872.
- Gulati A, Paige D, Yaqoob M, et al. Palisaded neutrophilic granulomatous dermatitis associated with systemic lupus erythematosus presenting with the burning rope sign. J Am Acad Dermatol. 2009;61:711-714.
- Tomasini C, Pippione M. Interstitial granulomatous dermatitis with plaques. J Am Acad Dermatol. 2002;46:892-899.
- Fett N, Kovarik C, Bennett D. Palisaded neutrophilic granulomatous dermatitis without a definable underlying disorder treated with dapsone. J Am Acad Dermatol. 2011;65:E92-E93.
- Verneuil L, Dompmartin A, Comoz F, et al. Interstitial granulomatous dermatitis with cutaneous cords and arthritis: a disorder associated with autoantibodies. J Am Acad Dermatol. 2001;45:286-291.
To the Editor:
Palisaded neutrophilic granulomatous dermatitis (PNGD) is a rare disorder that often is associated with systemic disease. It has been shown to manifest in the presence of systemic lupus erythematosus; rheumatoid arthritis; Wegener granulomatosis; and other diseases, mainly autoimmune conditions. Interstitial granulomatous dermatitis (IGD) associated with arthritis was first described by Ackerman et al1 in 1993. In 1994, IGD was placed among the spectrum of PNGD by Chu et al.2 The disease entities included in the spectrum of PNGD of the immune complex disease are Churg-Strauss granuloma, cutaneous extravascular necrotizing granuloma, rheumatoid papules, superficial ulcerating rheumatoid necrobiosis, and IGD with arthritis.2 It has been suggested that IGD has a distinct clinical presentation with associated histopathology, while others suggest it still is part of the PNGD spectrum.2,3 We present 2 cases of granulomatous dermatitis and their findings related to IGD and PNGD.
A 58-year-old woman presented with recurrent painful lesions on the trunk, arms, and legs of 2 years’ duration. The lesions spontaneously resolved without scarring or hyperpigmentation but would recur in different areas on the trunk. She was diagnosed with rheumatoid arthritis following a recent autoimmune workup. At presentation, physical examination revealed tender erythematous edematous plaques on the bilateral upper back (Figure 1) and erythematous nodules on the bilateral upper arms. The patient previously had an antinuclear antibody titer of 1:320 with a speckled pattern. A repeat antinuclear antibody titer taken 1 year later was negative. Her rheumatoid factor initially was positive and remained positive upon repeat testing. Punch biopsies were performed for histologic evaluation of the lesions and immunofluorescence. Biopsies examined with hematoxylin and eosin stain revealed perivascular and interstitial mixed (lymphocytic, neutrophilic, eosinophilic) bottom-heavy inflammation with nuclear dust and basophilic degeneration of collagen (Figure 2). Immunofluorescence studies were negative. The patient deferred treatment.
A 74-year-old man presented with a rash on the flank and back with associated pruritus and occasional pain of 2 months’ duration. His primary care physician prescribed a course of cephalexin, but the rash did not improve. Review of systems was positive for intermittent swelling of the hands, feet, and lips, and negative for arthritis. His medical history included 2 episodes of rheumatic fever, one complicated by pneumonia. His medications included finasteride, simvastatin, bisoprolol-hydrochlorothiazide, aspirin, tiotropium, vitamin D, and fish oil. At presentation, physical examination revealed tender violaceous plaques with induration and central clearing distributed on the left side of the back, left side of the flank, and left axilla. The lesion on the axilla measured 30.0×3.5 cm and the lesions on the left side of the back measured 30.0×9.0 cm. The rims of the lesions were elevated and consistent with the rope sign (Figure 3). A punch biopsy of the lesion on the left axilla showed perivascular and interstitial infiltrate of lymphocytes, neutrophils, histiocytes, and eosinophils. There was no evidence of fibrin deposition in the blood vessels. Small areas of necrobiotic collagen surrounded by multinucleated giant cells and lymphocytes were noted (Figure 4). The rash improved spontaneously at the time of suture removal. No treatment was initiated.
Granulomatous dermatitis in the presence of an autoimmune disorder can present as IGD or PNGD. Both forms of granulomatous dermatitis are rare conditions and considered to be part of the same clinicopathological spectrum. These conditions can be difficult to distinguish clinically but are histologically unique.
Interstitial granulomatous dermatitis and PNGD can have a variable clinical expression. Palisaded neutrophilic granulomatous dermatitis generally presents as flesh-colored to erythematous papules or plaques, most commonly located on the upper arms. The lesions may have a central umbilication with perforation and ulceration.4 Interstitial granulomatous dermatitis most commonly presents as erythematous plaques and papules. The lesions are symmetric and asymptomatic. They most commonly appear on the trunk, axillae, buttocks, thighs, and groin. Subcutaneous linear cords (the rope sign) is a characteristic associated with IGD.3,5 However, the rope sign also has been reported in a patient with PNGD with systemic lupus,6 which further demonstrates the overlapping spectrum of clinical expression seen in these 2 forms of granulomatous dermatitis. Therefore, a diagnosis cannot be made by clinical expression alone; histologic findings are needed for confirmation.
When differentiating IGD and PNGD histologically, it is important to keep in mind that these features exist on a spectrum and depend on the age of the lesion. Deposition of the immune complex around the dermal blood vessel initiates the pathogenesis. Early lesions of PNGD show a neutrophilic infiltrate, focal leukocytoclastic vasculitis, and dense nuclear dust. Developed lesions show zones of basophilic degenerated collagen surrounded by palisades of histiocytes, neutrophils, and nuclear debris.2 The histologic pattern of IGD features smaller areas of palisading histiocytes surrounding foci of degenerated collagen. Neutrophils and eosinophils are seen among the degenerated collagen. There is no evidence of vasculitis and dermal mucin usually is absent.7
Palisaded neutrophilic granulomatous dermatitis has been reported to improve with systemic steroids and dapsone.8 Th
Some authors have disputed the spectrum that Chu et al2 had determined in their study and proposed IGD is a separate entity from the PNGD spectrum. Verneuil et al9 stated that the clinical presentations in Chu et al’s2 study (symmetric papules of the extremities) had not been reported in a patient with IGD. However, in a study of IGD by Peroni et al,3 7 of 12 patients presented with symmetrical papules of the extremities. We believe that the spectrum proposed by Chu et al2 still holds true.
These 2 reports demonstrate the diverse presentation of IGD and PNGD. It is important for dermatologists to keep in mind the PNGD spectrum when a patient presents with granulomatous dermatitis in the presence of an autoimmune disorder.
To the Editor:
Palisaded neutrophilic granulomatous dermatitis (PNGD) is a rare disorder that often is associated with systemic disease. It has been shown to manifest in the presence of systemic lupus erythematosus; rheumatoid arthritis; Wegener granulomatosis; and other diseases, mainly autoimmune conditions. Interstitial granulomatous dermatitis (IGD) associated with arthritis was first described by Ackerman et al1 in 1993. In 1994, IGD was placed among the spectrum of PNGD by Chu et al.2 The disease entities included in the spectrum of PNGD of the immune complex disease are Churg-Strauss granuloma, cutaneous extravascular necrotizing granuloma, rheumatoid papules, superficial ulcerating rheumatoid necrobiosis, and IGD with arthritis.2 It has been suggested that IGD has a distinct clinical presentation with associated histopathology, while others suggest it still is part of the PNGD spectrum.2,3 We present 2 cases of granulomatous dermatitis and their findings related to IGD and PNGD.
A 58-year-old woman presented with recurrent painful lesions on the trunk, arms, and legs of 2 years’ duration. The lesions spontaneously resolved without scarring or hyperpigmentation but would recur in different areas on the trunk. She was diagnosed with rheumatoid arthritis following a recent autoimmune workup. At presentation, physical examination revealed tender erythematous edematous plaques on the bilateral upper back (Figure 1) and erythematous nodules on the bilateral upper arms. The patient previously had an antinuclear antibody titer of 1:320 with a speckled pattern. A repeat antinuclear antibody titer taken 1 year later was negative. Her rheumatoid factor initially was positive and remained positive upon repeat testing. Punch biopsies were performed for histologic evaluation of the lesions and immunofluorescence. Biopsies examined with hematoxylin and eosin stain revealed perivascular and interstitial mixed (lymphocytic, neutrophilic, eosinophilic) bottom-heavy inflammation with nuclear dust and basophilic degeneration of collagen (Figure 2). Immunofluorescence studies were negative. The patient deferred treatment.
A 74-year-old man presented with a rash on the flank and back with associated pruritus and occasional pain of 2 months’ duration. His primary care physician prescribed a course of cephalexin, but the rash did not improve. Review of systems was positive for intermittent swelling of the hands, feet, and lips, and negative for arthritis. His medical history included 2 episodes of rheumatic fever, one complicated by pneumonia. His medications included finasteride, simvastatin, bisoprolol-hydrochlorothiazide, aspirin, tiotropium, vitamin D, and fish oil. At presentation, physical examination revealed tender violaceous plaques with induration and central clearing distributed on the left side of the back, left side of the flank, and left axilla. The lesion on the axilla measured 30.0×3.5 cm and the lesions on the left side of the back measured 30.0×9.0 cm. The rims of the lesions were elevated and consistent with the rope sign (Figure 3). A punch biopsy of the lesion on the left axilla showed perivascular and interstitial infiltrate of lymphocytes, neutrophils, histiocytes, and eosinophils. There was no evidence of fibrin deposition in the blood vessels. Small areas of necrobiotic collagen surrounded by multinucleated giant cells and lymphocytes were noted (Figure 4). The rash improved spontaneously at the time of suture removal. No treatment was initiated.
Granulomatous dermatitis in the presence of an autoimmune disorder can present as IGD or PNGD. Both forms of granulomatous dermatitis are rare conditions and considered to be part of the same clinicopathological spectrum. These conditions can be difficult to distinguish clinically but are histologically unique.
Interstitial granulomatous dermatitis and PNGD can have a variable clinical expression. Palisaded neutrophilic granulomatous dermatitis generally presents as flesh-colored to erythematous papules or plaques, most commonly located on the upper arms. The lesions may have a central umbilication with perforation and ulceration.4 Interstitial granulomatous dermatitis most commonly presents as erythematous plaques and papules. The lesions are symmetric and asymptomatic. They most commonly appear on the trunk, axillae, buttocks, thighs, and groin. Subcutaneous linear cords (the rope sign) is a characteristic associated with IGD.3,5 However, the rope sign also has been reported in a patient with PNGD with systemic lupus,6 which further demonstrates the overlapping spectrum of clinical expression seen in these 2 forms of granulomatous dermatitis. Therefore, a diagnosis cannot be made by clinical expression alone; histologic findings are needed for confirmation.
When differentiating IGD and PNGD histologically, it is important to keep in mind that these features exist on a spectrum and depend on the age of the lesion. Deposition of the immune complex around the dermal blood vessel initiates the pathogenesis. Early lesions of PNGD show a neutrophilic infiltrate, focal leukocytoclastic vasculitis, and dense nuclear dust. Developed lesions show zones of basophilic degenerated collagen surrounded by palisades of histiocytes, neutrophils, and nuclear debris.2 The histologic pattern of IGD features smaller areas of palisading histiocytes surrounding foci of degenerated collagen. Neutrophils and eosinophils are seen among the degenerated collagen. There is no evidence of vasculitis and dermal mucin usually is absent.7
Palisaded neutrophilic granulomatous dermatitis has been reported to improve with systemic steroids and dapsone.8 Th
Some authors have disputed the spectrum that Chu et al2 had determined in their study and proposed IGD is a separate entity from the PNGD spectrum. Verneuil et al9 stated that the clinical presentations in Chu et al’s2 study (symmetric papules of the extremities) had not been reported in a patient with IGD. However, in a study of IGD by Peroni et al,3 7 of 12 patients presented with symmetrical papules of the extremities. We believe that the spectrum proposed by Chu et al2 still holds true.
These 2 reports demonstrate the diverse presentation of IGD and PNGD. It is important for dermatologists to keep in mind the PNGD spectrum when a patient presents with granulomatous dermatitis in the presence of an autoimmune disorder.
- Ackerman AB, Guo Y, Vitale P. Clues to diagnosis in dermatopathology. Am Society Clin Pathol. 1993;3:309-312.
- Chu P, Connolly MK, LeBoit PE. The histopathologic spectrum of palisaded neutrophilic and granulomatous dermatitis in patients with collagen vascular disease. Arch Dermatol. 1994;130:1278-1283.
- Peroni A, Colato C, Schena D, et al. Interstitial granulomatous dermatitis: a distinct entity with characteristic histological and clinical pattern. Br J Dermatol. 2012;166:775-783.
- Hantash BM, Chiang D, Kohler S, et al. Palisaded neutrophilic and granulomatous dermatitis associated with limited systemic sclerosis. J Am Acad Dermatol. 2008;58:661-664.
- Garcia-Rabasco A, Esteve-Martinez A, Zaragoza-Ninet V, et al. Interstitial granulomatous dermatitis in a patient with lupus erythematosus. Am J Dermatopathol. 2011;33:871-872.
- Gulati A, Paige D, Yaqoob M, et al. Palisaded neutrophilic granulomatous dermatitis associated with systemic lupus erythematosus presenting with the burning rope sign. J Am Acad Dermatol. 2009;61:711-714.
- Tomasini C, Pippione M. Interstitial granulomatous dermatitis with plaques. J Am Acad Dermatol. 2002;46:892-899.
- Fett N, Kovarik C, Bennett D. Palisaded neutrophilic granulomatous dermatitis without a definable underlying disorder treated with dapsone. J Am Acad Dermatol. 2011;65:E92-E93.
- Verneuil L, Dompmartin A, Comoz F, et al. Interstitial granulomatous dermatitis with cutaneous cords and arthritis: a disorder associated with autoantibodies. J Am Acad Dermatol. 2001;45:286-291.
- Ackerman AB, Guo Y, Vitale P. Clues to diagnosis in dermatopathology. Am Society Clin Pathol. 1993;3:309-312.
- Chu P, Connolly MK, LeBoit PE. The histopathologic spectrum of palisaded neutrophilic and granulomatous dermatitis in patients with collagen vascular disease. Arch Dermatol. 1994;130:1278-1283.
- Peroni A, Colato C, Schena D, et al. Interstitial granulomatous dermatitis: a distinct entity with characteristic histological and clinical pattern. Br J Dermatol. 2012;166:775-783.
- Hantash BM, Chiang D, Kohler S, et al. Palisaded neutrophilic and granulomatous dermatitis associated with limited systemic sclerosis. J Am Acad Dermatol. 2008;58:661-664.
- Garcia-Rabasco A, Esteve-Martinez A, Zaragoza-Ninet V, et al. Interstitial granulomatous dermatitis in a patient with lupus erythematosus. Am J Dermatopathol. 2011;33:871-872.
- Gulati A, Paige D, Yaqoob M, et al. Palisaded neutrophilic granulomatous dermatitis associated with systemic lupus erythematosus presenting with the burning rope sign. J Am Acad Dermatol. 2009;61:711-714.
- Tomasini C, Pippione M. Interstitial granulomatous dermatitis with plaques. J Am Acad Dermatol. 2002;46:892-899.
- Fett N, Kovarik C, Bennett D. Palisaded neutrophilic granulomatous dermatitis without a definable underlying disorder treated with dapsone. J Am Acad Dermatol. 2011;65:E92-E93.
- Verneuil L, Dompmartin A, Comoz F, et al. Interstitial granulomatous dermatitis with cutaneous cords and arthritis: a disorder associated with autoantibodies. J Am Acad Dermatol. 2001;45:286-291.
Practice Points
- The clinical features of interstitial granulomatous dermatitis and palisaded neutrophilic granulomatous dermatitis exist on a spectrum, and these is considerable overlap between the features of these 2 clinicopathologic entities.
- Interstitial granulomatous dermatitis and palisaded neutrophilic granulomatous dermatitis may respond to systemic steroids or treatment of the underlying systemic disease. Some cases spontaneously resolve.
Simple tool improves inpatient influenza vaccination rates
TORONTO –
“When we looked at the immunization status of children in New York City, we found that one of the vaccines most commonly missed was influenza vaccine, especially from 2011 through 2014,” one of the study authors, Anmol Goyal, MD, of SUNY Downstate Medical Center, Brooklyn, N.Y., said in an interview at the Pediatric Academic Societies meeting.
“Given this year’s epidemic of influenza and the increasing deaths, we decided to look back on interventions we had done in the past to see if any can be reimplemented to help improve the vaccination status for these children,” he said. “The national goal is 80%, but if we look at the recent trend, even though we have been able to improve vaccination status, it is still below the national goal.” For example, he said, according to New York Department of Health data, the 2012-2013 influenza vaccination rates in New York City were 65% among children 6 months to 5 years old, 47% among those 5-8 years old, and 31% among those 9-18 years old, which were well below the national goal.
In an effort to improve influenza vaccine access, lead author Stephan Kohlhoff, MD, a pediatric infectious disease specialist at the medical center, and his associates, implemented a simple vaccine screening tool to use in the inpatient setting as an opportunity to improve vaccination rates among children in New York City. It consisted of nursing staff assessing the patient’s influenza immunization status on admission and conducting source verification using the citywide immunization registry, or with vaccine cards brought by parents or guardians during admission. Influenza vaccine was administered as a standing order before discharge, unless refused by the parents or guardians. The study population comprised 602 patients between the ages of 6 months and 21 years who were admitted to the inpatient unit during 2 months of the influenza season (November and December) from 2011 to 2013.
Dr. Goyal, a second-year pediatric resident at the medical center, reported that the influenza vaccination status on admission was positive in only 31% of children in 2011, 30% in 2012, and 34% in 2013. The vaccine screening tool was implemented in 64% of admitted children in 2012 and 70% in 2013. Following implementation, the researchers observed a 5% increase in immunization rates in 2012 and an 11% increase in 2013, with an overall increase of 8% over 2 years (P less than .001). He was quick to point out that the influenza rate could have been improved by an additional 22% had 77% of patients not refused vaccination.
“Unfortunately, as our primary objective was to assess the utility of our screening tool in improving inpatient immunization status, we had very limited data points toward refusal of vaccine,” Dr. Goyal said. “Some of the reasons for refusal that were gathered during screening included preferred vaccination by their primary care provider after discharge. Or, maybe they don’t want the vaccine because they feel that the vaccine will make their kids sick. We don’t have enough data to point to any particular reason. This study provides information on acceptance rate of inpatient immunization, which may be useful for implementing additional educational initiatives to overcome potential barriers and help us reach our national goal.”
The researchers reported having no financial disclosures.
TORONTO –
“When we looked at the immunization status of children in New York City, we found that one of the vaccines most commonly missed was influenza vaccine, especially from 2011 through 2014,” one of the study authors, Anmol Goyal, MD, of SUNY Downstate Medical Center, Brooklyn, N.Y., said in an interview at the Pediatric Academic Societies meeting.
“Given this year’s epidemic of influenza and the increasing deaths, we decided to look back on interventions we had done in the past to see if any can be reimplemented to help improve the vaccination status for these children,” he said. “The national goal is 80%, but if we look at the recent trend, even though we have been able to improve vaccination status, it is still below the national goal.” For example, he said, according to New York Department of Health data, the 2012-2013 influenza vaccination rates in New York City were 65% among children 6 months to 5 years old, 47% among those 5-8 years old, and 31% among those 9-18 years old, which were well below the national goal.
In an effort to improve influenza vaccine access, lead author Stephan Kohlhoff, MD, a pediatric infectious disease specialist at the medical center, and his associates, implemented a simple vaccine screening tool to use in the inpatient setting as an opportunity to improve vaccination rates among children in New York City. It consisted of nursing staff assessing the patient’s influenza immunization status on admission and conducting source verification using the citywide immunization registry, or with vaccine cards brought by parents or guardians during admission. Influenza vaccine was administered as a standing order before discharge, unless refused by the parents or guardians. The study population comprised 602 patients between the ages of 6 months and 21 years who were admitted to the inpatient unit during 2 months of the influenza season (November and December) from 2011 to 2013.
Dr. Goyal, a second-year pediatric resident at the medical center, reported that the influenza vaccination status on admission was positive in only 31% of children in 2011, 30% in 2012, and 34% in 2013. The vaccine screening tool was implemented in 64% of admitted children in 2012 and 70% in 2013. Following implementation, the researchers observed a 5% increase in immunization rates in 2012 and an 11% increase in 2013, with an overall increase of 8% over 2 years (P less than .001). He was quick to point out that the influenza rate could have been improved by an additional 22% had 77% of patients not refused vaccination.
“Unfortunately, as our primary objective was to assess the utility of our screening tool in improving inpatient immunization status, we had very limited data points toward refusal of vaccine,” Dr. Goyal said. “Some of the reasons for refusal that were gathered during screening included preferred vaccination by their primary care provider after discharge. Or, maybe they don’t want the vaccine because they feel that the vaccine will make their kids sick. We don’t have enough data to point to any particular reason. This study provides information on acceptance rate of inpatient immunization, which may be useful for implementing additional educational initiatives to overcome potential barriers and help us reach our national goal.”
The researchers reported having no financial disclosures.
TORONTO –
“When we looked at the immunization status of children in New York City, we found that one of the vaccines most commonly missed was influenza vaccine, especially from 2011 through 2014,” one of the study authors, Anmol Goyal, MD, of SUNY Downstate Medical Center, Brooklyn, N.Y., said in an interview at the Pediatric Academic Societies meeting.
“Given this year’s epidemic of influenza and the increasing deaths, we decided to look back on interventions we had done in the past to see if any can be reimplemented to help improve the vaccination status for these children,” he said. “The national goal is 80%, but if we look at the recent trend, even though we have been able to improve vaccination status, it is still below the national goal.” For example, he said, according to New York Department of Health data, the 2012-2013 influenza vaccination rates in New York City were 65% among children 6 months to 5 years old, 47% among those 5-8 years old, and 31% among those 9-18 years old, which were well below the national goal.
In an effort to improve influenza vaccine access, lead author Stephan Kohlhoff, MD, a pediatric infectious disease specialist at the medical center, and his associates, implemented a simple vaccine screening tool to use in the inpatient setting as an opportunity to improve vaccination rates among children in New York City. It consisted of nursing staff assessing the patient’s influenza immunization status on admission and conducting source verification using the citywide immunization registry, or with vaccine cards brought by parents or guardians during admission. Influenza vaccine was administered as a standing order before discharge, unless refused by the parents or guardians. The study population comprised 602 patients between the ages of 6 months and 21 years who were admitted to the inpatient unit during 2 months of the influenza season (November and December) from 2011 to 2013.
Dr. Goyal, a second-year pediatric resident at the medical center, reported that the influenza vaccination status on admission was positive in only 31% of children in 2011, 30% in 2012, and 34% in 2013. The vaccine screening tool was implemented in 64% of admitted children in 2012 and 70% in 2013. Following implementation, the researchers observed a 5% increase in immunization rates in 2012 and an 11% increase in 2013, with an overall increase of 8% over 2 years (P less than .001). He was quick to point out that the influenza rate could have been improved by an additional 22% had 77% of patients not refused vaccination.
“Unfortunately, as our primary objective was to assess the utility of our screening tool in improving inpatient immunization status, we had very limited data points toward refusal of vaccine,” Dr. Goyal said. “Some of the reasons for refusal that were gathered during screening included preferred vaccination by their primary care provider after discharge. Or, maybe they don’t want the vaccine because they feel that the vaccine will make their kids sick. We don’t have enough data to point to any particular reason. This study provides information on acceptance rate of inpatient immunization, which may be useful for implementing additional educational initiatives to overcome potential barriers and help us reach our national goal.”
The researchers reported having no financial disclosures.
AT PAS 18
Key clinical point: The inpatient setting can be used to successfully improve influenza vaccine rates.
Major finding: Following implementation of a simple inpatient vaccine screening tool, a 5% increase in immunization rates occurred in 2012 and an 11% increase occurred in 2013.
Study details: A review of 602 patients between the ages of 6 months and 21 years who were admitted to the inpatient unit during 2 months of the influenza season (November and December) from 2011 to 2013.
Disclosures: The researchers reported having no financial disclosures.
Endocrinologists well positioned to be experts on changes in transgender care
according to Joshua D. Safer, MD, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York.
“It’s not that we have to be the experts on making diagnoses or other elements of transgender care, necessarily,” Dr. Safer said in an interview here at the annual scientific & clinical congress of the American Association of Clinical Endocrinologists.
In a meet-the-expert session at AACE, Dr. Safer talked about the “change in landscape” in transgender medical care that precipitated the Endocrine Society clinical practice guideline on endocrine treatment of gender-dysphoric/gender-incongruent individuals.
The new guidelines, published just this past fall, updated guidance published by the society back in 2009.
One big change for pediatrics in the new guidelines is the recognition that there may be “compelling reasons” to start cross-sex hormonal therapy prior to 16 years, the former age cut-off. Sixteen years is “very late if you’re thinking about it from a biological perspective,” said Dr. Safer, who was a coauthor of the new guidelines.
While there are only limited data on using gender-affirming hormones in younger adolescents, there are potential risks of waiting until age 16 years in some cases, according to the guidelines.
For example, an individual who reaches Tanner stage 2 at age 9-10 years might be at risk of bone health issues if puberty is suppressed for 6-7 years before initiating sex hormones. Other risks could include inappropriate height or emotional/social isolation if the adolescent has to wait until age 16 years for initiation of secondary sex characteristics. On the adult side, one of the biggest changes is removing the idea that a mental health professional is necessary to make the diagnosis. In truth, any knowledgeable clinician could make that diagnosis, according to Dr. Safer.
A transgender individual’s treatment team should include several providers, according to guidelines: a medical provider who is knowledgeable in transgender hormone therapy, a mental health provider who is knowledgeable in gender dysphoria/gender incongruence and transition-associated mental health concerns, plus a primary care provider who can provide care appropriate to transgender needs.
Nonbinary persons (that is, those not exclusively identifying as either male or female) might need some “special tailoring” of treatment within accepted safety guidelines, Dr. Safer noted. Endocrinologists should provide education regarding onset and time course of physical changes induced by sex hormones for transgender individuals undergoing treatment, the guidelines also recommend.
It’s very important for endocrinologists to be familiar with why the landscape has changed for transgender health care, Dr. Safer said at the meeting.
“It’s not that we’ve all decided to be more tolerant or something along those lines,” he said in the interview. “It’s that even those of us who have been very skeptical in the medical and scientific community have recognized that there is clearly a biological component to gender identity.”
according to Joshua D. Safer, MD, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York.
“It’s not that we have to be the experts on making diagnoses or other elements of transgender care, necessarily,” Dr. Safer said in an interview here at the annual scientific & clinical congress of the American Association of Clinical Endocrinologists.
In a meet-the-expert session at AACE, Dr. Safer talked about the “change in landscape” in transgender medical care that precipitated the Endocrine Society clinical practice guideline on endocrine treatment of gender-dysphoric/gender-incongruent individuals.
The new guidelines, published just this past fall, updated guidance published by the society back in 2009.
One big change for pediatrics in the new guidelines is the recognition that there may be “compelling reasons” to start cross-sex hormonal therapy prior to 16 years, the former age cut-off. Sixteen years is “very late if you’re thinking about it from a biological perspective,” said Dr. Safer, who was a coauthor of the new guidelines.
While there are only limited data on using gender-affirming hormones in younger adolescents, there are potential risks of waiting until age 16 years in some cases, according to the guidelines.
For example, an individual who reaches Tanner stage 2 at age 9-10 years might be at risk of bone health issues if puberty is suppressed for 6-7 years before initiating sex hormones. Other risks could include inappropriate height or emotional/social isolation if the adolescent has to wait until age 16 years for initiation of secondary sex characteristics. On the adult side, one of the biggest changes is removing the idea that a mental health professional is necessary to make the diagnosis. In truth, any knowledgeable clinician could make that diagnosis, according to Dr. Safer.
A transgender individual’s treatment team should include several providers, according to guidelines: a medical provider who is knowledgeable in transgender hormone therapy, a mental health provider who is knowledgeable in gender dysphoria/gender incongruence and transition-associated mental health concerns, plus a primary care provider who can provide care appropriate to transgender needs.
Nonbinary persons (that is, those not exclusively identifying as either male or female) might need some “special tailoring” of treatment within accepted safety guidelines, Dr. Safer noted. Endocrinologists should provide education regarding onset and time course of physical changes induced by sex hormones for transgender individuals undergoing treatment, the guidelines also recommend.
It’s very important for endocrinologists to be familiar with why the landscape has changed for transgender health care, Dr. Safer said at the meeting.
“It’s not that we’ve all decided to be more tolerant or something along those lines,” he said in the interview. “It’s that even those of us who have been very skeptical in the medical and scientific community have recognized that there is clearly a biological component to gender identity.”
according to Joshua D. Safer, MD, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York.
“It’s not that we have to be the experts on making diagnoses or other elements of transgender care, necessarily,” Dr. Safer said in an interview here at the annual scientific & clinical congress of the American Association of Clinical Endocrinologists.
In a meet-the-expert session at AACE, Dr. Safer talked about the “change in landscape” in transgender medical care that precipitated the Endocrine Society clinical practice guideline on endocrine treatment of gender-dysphoric/gender-incongruent individuals.
The new guidelines, published just this past fall, updated guidance published by the society back in 2009.
One big change for pediatrics in the new guidelines is the recognition that there may be “compelling reasons” to start cross-sex hormonal therapy prior to 16 years, the former age cut-off. Sixteen years is “very late if you’re thinking about it from a biological perspective,” said Dr. Safer, who was a coauthor of the new guidelines.
While there are only limited data on using gender-affirming hormones in younger adolescents, there are potential risks of waiting until age 16 years in some cases, according to the guidelines.
For example, an individual who reaches Tanner stage 2 at age 9-10 years might be at risk of bone health issues if puberty is suppressed for 6-7 years before initiating sex hormones. Other risks could include inappropriate height or emotional/social isolation if the adolescent has to wait until age 16 years for initiation of secondary sex characteristics. On the adult side, one of the biggest changes is removing the idea that a mental health professional is necessary to make the diagnosis. In truth, any knowledgeable clinician could make that diagnosis, according to Dr. Safer.
A transgender individual’s treatment team should include several providers, according to guidelines: a medical provider who is knowledgeable in transgender hormone therapy, a mental health provider who is knowledgeable in gender dysphoria/gender incongruence and transition-associated mental health concerns, plus a primary care provider who can provide care appropriate to transgender needs.
Nonbinary persons (that is, those not exclusively identifying as either male or female) might need some “special tailoring” of treatment within accepted safety guidelines, Dr. Safer noted. Endocrinologists should provide education regarding onset and time course of physical changes induced by sex hormones for transgender individuals undergoing treatment, the guidelines also recommend.
It’s very important for endocrinologists to be familiar with why the landscape has changed for transgender health care, Dr. Safer said at the meeting.
“It’s not that we’ve all decided to be more tolerant or something along those lines,” he said in the interview. “It’s that even those of us who have been very skeptical in the medical and scientific community have recognized that there is clearly a biological component to gender identity.”
REPORTING FROM AACE 2018