More transplant centers are offering liver transplantation as a viable therapeutic option for patients with severe alcoholic hepatitis who do not respond to steroid treatment.

“Alcoholic hepatitis is a disease caused by drinking alcohol. Excessive alcohol consumption causes fat to build up in your liver cells, as well as inflammation and scarring of the liver,” stated Saroja Bangaru, MD, chief resident at the University of Texas, Dallas. “Severe alcoholic hepatitis has an extremely high mortality and steroids are really the mainstay of therapy. Some alcoholic hepatitis patients do not respond to steroids and a significant percentage of them will die within 3 months. For these patients, liver transplantation is a therapeutic option.”

Dr. Bangaru and her colleagues conducted a survey that gathered data from 45 transplant centers in the United States and found that an increasing number have changed this practice and now offer liver transplantation to patients with severe alcoholic hepatitis.

The survey revealed that 51.1% of the 45 clinics offered liver transplantation to patients who had not yet been sober for 6 months, and 47.8% of transplant centers reported performing at least one liver transplant for severe alcoholic hepatitis. Just over a third (34.8%) of these centers had conducted three to five liver transplants, while only 8.9% of clinics performed at least six transplants. It is of note that most clinics have transplanted livers in fewer than five patients with severe alcoholic hepatitis, Dr. Bangaru said at the annual Digestive Disease Week^®.

Patients experienced positive outcomes from these transplants, with almost 75% of surveyed clinics reporting 1-year survival rates of more than 90%, and 15% reporting 1-year survival rates of 80%-90%.

A factor that may have contributed to such positive outcomes was good patient selection based on liver transplant criteria for severe alcoholic hepatitis. More than 85% of center directors believed that liver transplant candidates should have a strong social support system, absence of severe psychiatric disorders, and a completed psychosocial evaluation, among other criteria.

Dr. Bangaru pointed out that the change in treating patients who have not abstained from alcohol is a break from traditional medical practice. “Historically, transplant centers would not consider a liver transplantation as an option unless a patient had abstained from drinking alcohol for 6 months. This rule was due to a concern that the patient would return to drinking after transplant as well as a perceived high risk that patients who continued drinking would miss medical appointments, fail to take their immunosuppressants and medications, and that this would lead to eventual graft failure.”

Another compounding issue was that patients were not counseled on their alcohol consumption habits, leading to further issues with transplantation. “Not infrequently, patients receive a diagnosis of severe alcoholic hepatitis during their initial visit and no one had previously told them to stop drinking. Since their presentation was preceded by active alcohol consumption, they would essentially be rendered ineligible for a transplant at that time,” she said.

Despite the history surrounding liver transplants in patients with severe alcoholic hepatitis, Dr. Bangaru hopes the shift in practice will improve the lives of more patients. “Because this practice of transplantation is being increasingly accepted and demonstrating positive outcomes, the hope is that more patients will be evaluated for transplantation and that transplant centers will improve their posttransplant support to ensure patients have great success after transplantation.”

Digestive Disease Week^® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).

[email protected]

More transplant centers are offering liver transplantation as a viable therapeutic option for patients with severe alcoholic hepatitis who do not respond to steroid treatment.

“Alcoholic hepatitis is a disease caused by drinking alcohol. Excessive alcohol consumption causes fat to build up in your liver cells, as well as inflammation and scarring of the liver,” stated Saroja Bangaru, MD, chief resident at the University of Texas, Dallas. “Severe alcoholic hepatitis has an extremely high mortality and steroids are really the mainstay of therapy. Some alcoholic hepatitis patients do not respond to steroids and a significant percentage of them will die within 3 months. For these patients, liver transplantation is a therapeutic option.”

Dr. Bangaru and her colleagues conducted a survey that gathered data from 45 transplant centers in the United States and found that an increasing number have changed this practice and now offer liver transplantation to patients with severe alcoholic hepatitis.

The survey revealed that 51.1% of the 45 clinics offered liver transplantation to patients who had not yet been sober for 6 months, and 47.8% of transplant centers reported performing at least one liver transplant for severe alcoholic hepatitis. Just over a third (34.8%) of these centers had conducted three to five liver transplants, while only 8.9% of clinics performed at least six transplants. It is of note that most clinics have transplanted livers in fewer than five patients with severe alcoholic hepatitis, Dr. Bangaru said at the annual Digestive Disease Week^®.

Patients experienced positive outcomes from these transplants, with almost 75% of surveyed clinics reporting 1-year survival rates of more than 90%, and 15% reporting 1-year survival rates of 80%-90%.

A factor that may have contributed to such positive outcomes was good patient selection based on liver transplant criteria for severe alcoholic hepatitis. More than 85% of center directors believed that liver transplant candidates should have a strong social support system, absence of severe psychiatric disorders, and a completed psychosocial evaluation, among other criteria.

Dr. Bangaru pointed out that the change in treating patients who have not abstained from alcohol is a break from traditional medical practice. “Historically, transplant centers would not consider a liver transplantation as an option unless a patient had abstained from drinking alcohol for 6 months. This rule was due to a concern that the patient would return to drinking after transplant as well as a perceived high risk that patients who continued drinking would miss medical appointments, fail to take their immunosuppressants and medications, and that this would lead to eventual graft failure.”

Another compounding issue was that patients were not counseled on their alcohol consumption habits, leading to further issues with transplantation. “Not infrequently, patients receive a diagnosis of severe alcoholic hepatitis during their initial visit and no one had previously told them to stop drinking. Since their presentation was preceded by active alcohol consumption, they would essentially be rendered ineligible for a transplant at that time,” she said.

Despite the history surrounding liver transplants in patients with severe alcoholic hepatitis, Dr. Bangaru hopes the shift in practice will improve the lives of more patients. “Because this practice of transplantation is being increasingly accepted and demonstrating positive outcomes, the hope is that more patients will be evaluated for transplantation and that transplant centers will improve their posttransplant support to ensure patients have great success after transplantation.”

Digestive Disease Week^® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).

[email protected]

More transplant centers are offering liver transplantation as a viable therapeutic option for patients with severe alcoholic hepatitis who do not respond to steroid treatment.

“Alcoholic hepatitis is a disease caused by drinking alcohol. Excessive alcohol consumption causes fat to build up in your liver cells, as well as inflammation and scarring of the liver,” stated Saroja Bangaru, MD, chief resident at the University of Texas, Dallas. “Severe alcoholic hepatitis has an extremely high mortality and steroids are really the mainstay of therapy. Some alcoholic hepatitis patients do not respond to steroids and a significant percentage of them will die within 3 months. For these patients, liver transplantation is a therapeutic option.”

Dr. Bangaru and her colleagues conducted a survey that gathered data from 45 transplant centers in the United States and found that an increasing number have changed this practice and now offer liver transplantation to patients with severe alcoholic hepatitis.

The survey revealed that 51.1% of the 45 clinics offered liver transplantation to patients who had not yet been sober for 6 months, and 47.8% of transplant centers reported performing at least one liver transplant for severe alcoholic hepatitis. Just over a third (34.8%) of these centers had conducted three to five liver transplants, while only 8.9% of clinics performed at least six transplants. It is of note that most clinics have transplanted livers in fewer than five patients with severe alcoholic hepatitis, Dr. Bangaru said at the annual Digestive Disease Week^®.

Patients experienced positive outcomes from these transplants, with almost 75% of surveyed clinics reporting 1-year survival rates of more than 90%, and 15% reporting 1-year survival rates of 80%-90%.

A factor that may have contributed to such positive outcomes was good patient selection based on liver transplant criteria for severe alcoholic hepatitis. More than 85% of center directors believed that liver transplant candidates should have a strong social support system, absence of severe psychiatric disorders, and a completed psychosocial evaluation, among other criteria.

Dr. Bangaru pointed out that the change in treating patients who have not abstained from alcohol is a break from traditional medical practice. “Historically, transplant centers would not consider a liver transplantation as an option unless a patient had abstained from drinking alcohol for 6 months. This rule was due to a concern that the patient would return to drinking after transplant as well as a perceived high risk that patients who continued drinking would miss medical appointments, fail to take their immunosuppressants and medications, and that this would lead to eventual graft failure.”

Another compounding issue was that patients were not counseled on their alcohol consumption habits, leading to further issues with transplantation. “Not infrequently, patients receive a diagnosis of severe alcoholic hepatitis during their initial visit and no one had previously told them to stop drinking. Since their presentation was preceded by active alcohol consumption, they would essentially be rendered ineligible for a transplant at that time,” she said.

Despite the history surrounding liver transplants in patients with severe alcoholic hepatitis, Dr. Bangaru hopes the shift in practice will improve the lives of more patients. “Because this practice of transplantation is being increasingly accepted and demonstrating positive outcomes, the hope is that more patients will be evaluated for transplantation and that transplant centers will improve their posttransplant support to ensure patients have great success after transplantation.”

Digestive Disease Week^® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).

[email protected]

ORLANDO – Progression from cutaneous to systemic lupus happens far more quickly than is commonly reported in the literature, according to an investigation from Brigham and Women’s Hospital, Boston.

Most studies have emphasized mean time to progression, which is generally said to be about 8 years. The problem is that the range is broad, anywhere from a few months to 30 or more years, so “the outliers influence the mean, and therefore, may not provide a fully accurate representation of the interval in which [most] patients progress” from discoid lupus erythematosus (DLE) to systemic lupus erythematosus (SLE), lead investigator Scott Elman, MD, said at the International Conference on Cutaneous Lupus Erythematosus.

“As clinicians seeing DLE patients, the primary question we are asking ourselves is how frequently we should be monitoring for signs and symptoms of systemic lupus,” he said. Relying on mean time instead of median time might give a false sense of security – and even delay checking for arthritis, nephritis, and other manifestations. There’s no current standard of practice about when monitoring should occur, but “I certainly think that closer monitoring of new patients with a diagnosis of DLE, especially in their first couple of years,” is a good idea, he noted, adding that for most patients, “it seems that if it’s going to happen, it’s going to happen sooner” rather than later. At Brigham and Women’s, newly diagnosed patients are generally brought back every 3-6 months for lab tests and a thorough review of symptoms, Dr. Elman said.

The next step is to identify risk factors for early progression. The study did not find any significant differences in lab values, medication exposures, or disease manifestations between early and late progressors, perhaps because of the small sample size. The work continues.

There was no external funding for the work. Dr. Elman had no disclosures.

[email protected]

ORLANDO – Progression from cutaneous to systemic lupus happens far more quickly than is commonly reported in the literature, according to an investigation from Brigham and Women’s Hospital, Boston.

Most studies have emphasized mean time to progression, which is generally said to be about 8 years. The problem is that the range is broad, anywhere from a few months to 30 or more years, so “the outliers influence the mean, and therefore, may not provide a fully accurate representation of the interval in which [most] patients progress” from discoid lupus erythematosus (DLE) to systemic lupus erythematosus (SLE), lead investigator Scott Elman, MD, said at the International Conference on Cutaneous Lupus Erythematosus.

“As clinicians seeing DLE patients, the primary question we are asking ourselves is how frequently we should be monitoring for signs and symptoms of systemic lupus,” he said. Relying on mean time instead of median time might give a false sense of security – and even delay checking for arthritis, nephritis, and other manifestations. There’s no current standard of practice about when monitoring should occur, but “I certainly think that closer monitoring of new patients with a diagnosis of DLE, especially in their first couple of years,” is a good idea, he noted, adding that for most patients, “it seems that if it’s going to happen, it’s going to happen sooner” rather than later. At Brigham and Women’s, newly diagnosed patients are generally brought back every 3-6 months for lab tests and a thorough review of symptoms, Dr. Elman said.

The next step is to identify risk factors for early progression. The study did not find any significant differences in lab values, medication exposures, or disease manifestations between early and late progressors, perhaps because of the small sample size. The work continues.

There was no external funding for the work. Dr. Elman had no disclosures.

[email protected]

ORLANDO – Progression from cutaneous to systemic lupus happens far more quickly than is commonly reported in the literature, according to an investigation from Brigham and Women’s Hospital, Boston.

Most studies have emphasized mean time to progression, which is generally said to be about 8 years. The problem is that the range is broad, anywhere from a few months to 30 or more years, so “the outliers influence the mean, and therefore, may not provide a fully accurate representation of the interval in which [most] patients progress” from discoid lupus erythematosus (DLE) to systemic lupus erythematosus (SLE), lead investigator Scott Elman, MD, said at the International Conference on Cutaneous Lupus Erythematosus.

“As clinicians seeing DLE patients, the primary question we are asking ourselves is how frequently we should be monitoring for signs and symptoms of systemic lupus,” he said. Relying on mean time instead of median time might give a false sense of security – and even delay checking for arthritis, nephritis, and other manifestations. There’s no current standard of practice about when monitoring should occur, but “I certainly think that closer monitoring of new patients with a diagnosis of DLE, especially in their first couple of years,” is a good idea, he noted, adding that for most patients, “it seems that if it’s going to happen, it’s going to happen sooner” rather than later. At Brigham and Women’s, newly diagnosed patients are generally brought back every 3-6 months for lab tests and a thorough review of symptoms, Dr. Elman said.

The next step is to identify risk factors for early progression. The study did not find any significant differences in lab values, medication exposures, or disease manifestations between early and late progressors, perhaps because of the small sample size. The work continues.

There was no external funding for the work. Dr. Elman had no disclosures.

[email protected]

To the Editor:

A 34-year-old woman presented with a generalized pustular eruption with subjective fevers, chills, night sweats, and light-headedness. Ten days prior to admission she developed a generalized erythematous and pruritic rash; she had started pantoprazole for reflux 4 days prior to the rash. On admission, skin examination revealed facial edema and diffuse erythema covering 80% of the total body surface area with multiple 1- to 4-mm pustules coalescing into lakes of pus on the trunk as well as bilateral upper and lower arms and legs sparing the palms and soles. Desquamation and serous drainage with crust were observed on the skin of the head, upper trunk, and thighs (Figure 1). Vital signs were notable for hypotension. Laboratory tests on admission were remarkable for leukocytosis (white blood cell count: 22.5×10³/μL [reference range, 4.5–11×10³/μL]) with absolute eosinophilia but no neutrophilia. C-reactive protein (CRP) was elevated (237.9 mg/L [reference range, 5.0–9.9 mg/L]). Renal and hepatic functions were normal. Blood cultures grew methicillin-sensitive Staphylococcus aureus (MSSA). Further infectious disease workup for viral and fungal pathogens was negative.

Skin biopsy from the left thigh revealed subcorneal, pustular, acute spongiotic dermatitis with marked intraepidermal spongiosis and papillary edema; exocytosis of eosinophils; and single cell necrosis of keratinocytes (Figure 2). These findings were consistent with acute generalized exanthematous pustulosis (AGEP). Pantoprazole was discontinued, and cardiovascular support and antibiotic therapy for MSSA bacteremia were initiated. Respiratory, kidney, and liver functions remained normal throughout the 11-day hospitalization, and the pustular dermatitis, MSSA bacteremia, and cardiovascular symptoms resolved within 10 days.

Acute generalized exanthematous pustulosis is an uncommon, self-limited, generalized sterile pustular eruption notable for the usual absence of systemic symptoms and extracutaneous organ involvement. Hotz et al¹ found that mean peripheral neutrophil counts (mean, 21.5×10³/μL) and CRP levels (mean, 241.6 mg/L) were notably elevated in patients with systemic (ie, hepatic, pulmonary, renal, bone marrow) involvement. In our patient, only the CRP approached the elevated value reported by Hotz et al.¹ However, the patient exhibited only cardiovascular instability in the context of secondary bacteremia and no other systemic symptoms. The combination of highly elevated neutrophilia and CRP may be a better marker for AGEP-precipitated extracutaneous organ involvement.

Although infectious pathogens such as Epstein-Barr virus and cytomegalovirus have been implicated, the majority of AGEP cases are adverse reactions (ARs) to medications, such as β-lactam antibiotics. In our patient, the widely prescribed proton pump inhibitor (PPI) pantoprazole was the most likely cause. Acute generalized exanthematous pustulosis was reported in a patient taking another PPI, omeprazole.² However, PPIs are recognized to cause many cutaneous and other organ ARs, though prevalence of ARs is still low. In Thailand, Chularojanamontri et al³ reported 13.8 per 100,000 individuals developed a cutaneous AR to PPIs, and the ARs most frequently were attributed to omeprazole. They found that drug exanthems were the most common cutaneous ARs.³ However, more severe hypersensitivity reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and autoimmune eruptions such as cutaneous lupus erythematosus.^3,4 Other systemic reactions to PPIs include increased risks for urticaria, pneumonia, Clostridium difficile infections, and acute interstitial nephritis.^4,5

To the Editor:

A 34-year-old woman presented with a generalized pustular eruption with subjective fevers, chills, night sweats, and light-headedness. Ten days prior to admission she developed a generalized erythematous and pruritic rash; she had started pantoprazole for reflux 4 days prior to the rash. On admission, skin examination revealed facial edema and diffuse erythema covering 80% of the total body surface area with multiple 1- to 4-mm pustules coalescing into lakes of pus on the trunk as well as bilateral upper and lower arms and legs sparing the palms and soles. Desquamation and serous drainage with crust were observed on the skin of the head, upper trunk, and thighs (Figure 1). Vital signs were notable for hypotension. Laboratory tests on admission were remarkable for leukocytosis (white blood cell count: 22.5×10³/μL [reference range, 4.5–11×10³/μL]) with absolute eosinophilia but no neutrophilia. C-reactive protein (CRP) was elevated (237.9 mg/L [reference range, 5.0–9.9 mg/L]). Renal and hepatic functions were normal. Blood cultures grew methicillin-sensitive Staphylococcus aureus (MSSA). Further infectious disease workup for viral and fungal pathogens was negative.

Skin biopsy from the left thigh revealed subcorneal, pustular, acute spongiotic dermatitis with marked intraepidermal spongiosis and papillary edema; exocytosis of eosinophils; and single cell necrosis of keratinocytes (Figure 2). These findings were consistent with acute generalized exanthematous pustulosis (AGEP). Pantoprazole was discontinued, and cardiovascular support and antibiotic therapy for MSSA bacteremia were initiated. Respiratory, kidney, and liver functions remained normal throughout the 11-day hospitalization, and the pustular dermatitis, MSSA bacteremia, and cardiovascular symptoms resolved within 10 days.

Acute generalized exanthematous pustulosis is an uncommon, self-limited, generalized sterile pustular eruption notable for the usual absence of systemic symptoms and extracutaneous organ involvement. Hotz et al¹ found that mean peripheral neutrophil counts (mean, 21.5×10³/μL) and CRP levels (mean, 241.6 mg/L) were notably elevated in patients with systemic (ie, hepatic, pulmonary, renal, bone marrow) involvement. In our patient, only the CRP approached the elevated value reported by Hotz et al.¹ However, the patient exhibited only cardiovascular instability in the context of secondary bacteremia and no other systemic symptoms. The combination of highly elevated neutrophilia and CRP may be a better marker for AGEP-precipitated extracutaneous organ involvement.

Although infectious pathogens such as Epstein-Barr virus and cytomegalovirus have been implicated, the majority of AGEP cases are adverse reactions (ARs) to medications, such as β-lactam antibiotics. In our patient, the widely prescribed proton pump inhibitor (PPI) pantoprazole was the most likely cause. Acute generalized exanthematous pustulosis was reported in a patient taking another PPI, omeprazole.² However, PPIs are recognized to cause many cutaneous and other organ ARs, though prevalence of ARs is still low. In Thailand, Chularojanamontri et al³ reported 13.8 per 100,000 individuals developed a cutaneous AR to PPIs, and the ARs most frequently were attributed to omeprazole. They found that drug exanthems were the most common cutaneous ARs.³ However, more severe hypersensitivity reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and autoimmune eruptions such as cutaneous lupus erythematosus.^3,4 Other systemic reactions to PPIs include increased risks for urticaria, pneumonia, Clostridium difficile infections, and acute interstitial nephritis.^4,5

To the Editor:

A 34-year-old woman presented with a generalized pustular eruption with subjective fevers, chills, night sweats, and light-headedness. Ten days prior to admission she developed a generalized erythematous and pruritic rash; she had started pantoprazole for reflux 4 days prior to the rash. On admission, skin examination revealed facial edema and diffuse erythema covering 80% of the total body surface area with multiple 1- to 4-mm pustules coalescing into lakes of pus on the trunk as well as bilateral upper and lower arms and legs sparing the palms and soles. Desquamation and serous drainage with crust were observed on the skin of the head, upper trunk, and thighs (Figure 1). Vital signs were notable for hypotension. Laboratory tests on admission were remarkable for leukocytosis (white blood cell count: 22.5×10³/μL [reference range, 4.5–11×10³/μL]) with absolute eosinophilia but no neutrophilia. C-reactive protein (CRP) was elevated (237.9 mg/L [reference range, 5.0–9.9 mg/L]). Renal and hepatic functions were normal. Blood cultures grew methicillin-sensitive Staphylococcus aureus (MSSA). Further infectious disease workup for viral and fungal pathogens was negative.

Skin biopsy from the left thigh revealed subcorneal, pustular, acute spongiotic dermatitis with marked intraepidermal spongiosis and papillary edema; exocytosis of eosinophils; and single cell necrosis of keratinocytes (Figure 2). These findings were consistent with acute generalized exanthematous pustulosis (AGEP). Pantoprazole was discontinued, and cardiovascular support and antibiotic therapy for MSSA bacteremia were initiated. Respiratory, kidney, and liver functions remained normal throughout the 11-day hospitalization, and the pustular dermatitis, MSSA bacteremia, and cardiovascular symptoms resolved within 10 days.

Acute generalized exanthematous pustulosis is an uncommon, self-limited, generalized sterile pustular eruption notable for the usual absence of systemic symptoms and extracutaneous organ involvement. Hotz et al¹ found that mean peripheral neutrophil counts (mean, 21.5×10³/μL) and CRP levels (mean, 241.6 mg/L) were notably elevated in patients with systemic (ie, hepatic, pulmonary, renal, bone marrow) involvement. In our patient, only the CRP approached the elevated value reported by Hotz et al.¹ However, the patient exhibited only cardiovascular instability in the context of secondary bacteremia and no other systemic symptoms. The combination of highly elevated neutrophilia and CRP may be a better marker for AGEP-precipitated extracutaneous organ involvement.

Although infectious pathogens such as Epstein-Barr virus and cytomegalovirus have been implicated, the majority of AGEP cases are adverse reactions (ARs) to medications, such as β-lactam antibiotics. In our patient, the widely prescribed proton pump inhibitor (PPI) pantoprazole was the most likely cause. Acute generalized exanthematous pustulosis was reported in a patient taking another PPI, omeprazole.² However, PPIs are recognized to cause many cutaneous and other organ ARs, though prevalence of ARs is still low. In Thailand, Chularojanamontri et al³ reported 13.8 per 100,000 individuals developed a cutaneous AR to PPIs, and the ARs most frequently were attributed to omeprazole. They found that drug exanthems were the most common cutaneous ARs.³ However, more severe hypersensitivity reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and autoimmune eruptions such as cutaneous lupus erythematosus.^3,4 Other systemic reactions to PPIs include increased risks for urticaria, pneumonia, Clostridium difficile infections, and acute interstitial nephritis.^4,5

ORLANDO – Dermatologists and rheumatologists are mistaken if they think interface dermatitis is the sine qua non biopsy finding of dermatomyositis (DM), according to David Fiorentino, MD, PhD, professor of dermatology, rheumatology, and immunology at Stanford (Calif.) University.

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.

[email protected]

ORLANDO – Dermatologists and rheumatologists are mistaken if they think interface dermatitis is the sine qua non biopsy finding of dermatomyositis (DM), according to David Fiorentino, MD, PhD, professor of dermatology, rheumatology, and immunology at Stanford (Calif.) University.

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.

[email protected]

ORLANDO – Dermatologists and rheumatologists are mistaken if they think interface dermatitis is the sine qua non biopsy finding of dermatomyositis (DM), according to David Fiorentino, MD, PhD, professor of dermatology, rheumatology, and immunology at Stanford (Calif.) University.

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.

[email protected]

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.

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.

“This model can be easily implemented in a primary health care clinic to better reach adolescents who are unable or unwilling to seek mental health care,” 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.

Steve Debenport/Getty Images

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.

“This model can be easily implemented in a primary health care clinic to better reach adolescents who are unable or unwilling to seek mental health care,” 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.

Steve Debenport/Getty Images

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.

“This model can be easily implemented in a primary health care clinic to better reach adolescents who are unable or unwilling to seek mental health care,” 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.

Steve Debenport/Getty Images

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 approved treatment options and who are unable to participate in a clinical trial. “Our implementation of the Right to Try Act will build on our long-standing efforts to help patients and families who are facing life-threatening diseases or conditions, in a way that seeks to protect their autonomy, their safety, and the safety of others following in their paths,” said FDA Commissioner Scott Gottlieb, MD.

“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 approved treatment options and who are unable to participate in a clinical trial. “Our implementation of the Right to Try Act will build on our long-standing efforts to help patients and families who are facing life-threatening diseases or conditions, in a way that seeks to protect their autonomy, their safety, and the safety of others following in their paths,” said FDA Commissioner Scott Gottlieb, MD.

“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 approved treatment options and who are unable to participate in a clinical trial. “Our implementation of the Right to Try Act will build on our long-standing efforts to help patients and families who are facing life-threatening diseases or conditions, in a way that seeks to protect their autonomy, their safety, and the safety of others following in their paths,” said FDA Commissioner Scott Gottlieb, MD.

“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 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.

[email protected]

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.

[email protected]

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.

[email protected]

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.

CASE Failure to perform cesarean delivery^1–4

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 am and labor was uneventful until 1:20 pm when fetal heart monitoring showed deceleration of the baby’s heart rate. At 1:30 pm, oxytocin was discontinued because the fetal heart rate was nonreassuring. When the ObGyn arrived at the patient’s bedside at 1:49 pm, he ordered the oxytocin to be restarted because of irregular contractions. Oxytocin was given from 1:50 pm until delivery at 3:21 pm. During delivery, the ObGyn applied a Kiwi vacuum 3 times. Despite evidence of fetal distress, the ObGyn left the room several times.

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.

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 [email protected]. Please include your name and the city and state in which you practice.

CASE Failure to perform cesarean delivery^1–4

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 am and labor was uneventful until 1:20 pm when fetal heart monitoring showed deceleration of the baby’s heart rate. At 1:30 pm, oxytocin was discontinued because the fetal heart rate was nonreassuring. When the ObGyn arrived at the patient’s bedside at 1:49 pm, he ordered the oxytocin to be restarted because of irregular contractions. Oxytocin was given from 1:50 pm until delivery at 3:21 pm. During delivery, the ObGyn applied a Kiwi vacuum 3 times. Despite evidence of fetal distress, the ObGyn left the room several times.

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.

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 [email protected]. Please include your name and the city and state in which you practice.

CASE Failure to perform cesarean delivery^1–4

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 am and labor was uneventful until 1:20 pm when fetal heart monitoring showed deceleration of the baby’s heart rate. At 1:30 pm, oxytocin was discontinued because the fetal heart rate was nonreassuring. When the ObGyn arrived at the patient’s bedside at 1:49 pm, he ordered the oxytocin to be restarted because of irregular contractions. Oxytocin was given from 1:50 pm until delivery at 3:21 pm. During delivery, the ObGyn applied a Kiwi vacuum 3 times. Despite evidence of fetal distress, the ObGyn left the room several times.

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.

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 [email protected]. Please include your name and the city and state in which you practice.