MRI-guided focused ultrasound thalamotomy can significantly mitigate the severity of hand tremors in patients suffering from essential tremor, the most common type of movement disorder, according to a new study published in the New England Journal of Medicine.

“The use of ultrasound energy for the creation of discrete intracranial lesions... has been of interest since the middle of the 20th century,” wrote the investigators, led by W. Jeffrey Elias, MD, of the University of Virginia, Charlottesville. “Prospective pilot trials of focused ultrasound thalamotomy with magnetic resonance imaging (MRI) guidance in patients with essential tremor have shown reductions in hand tremor, improvements in quality of life, and minimal procedural morbidity.”

Courtesy The Ohio State University Wexner Medical Center

The trial enrolled a total of 76 patients with a mean age of 71 years and mean disease duration of nearly 17 years; 68% were men and 75% were white. At a 3:1 ratio, they were randomized into one of two cohorts: one underwent thalamotomy and the other received a “sham” procedure. The subjects were unaware which they received for the first 3 months. The Clinical Rating Scale for Tremor (CRST) and the Quality of Life in Essential Tremor Questionnaire (QUEST) was used to determine the severity of tremors at baseline, and at follow-ups conducted at 1, 3, 6, and 12 months post-procedure (N Engl J Med. 2016;375[8]:730-9).

The trial’s primary outcome of between-group difference in the change in tremor score from baseline to 3 months significantly favored thalamotomy (8.5-point improvement, from 18.1 to 9.6) over the sham procedure (0.2-point improvement, from 16.0 to 15.8). The mean between-group difference in the change in score of 8.3 points at 3 months decreased slightly to 7.2 points at 12 months. The tremor score (range, 0-32) was derived from part A of the CRST (three items: resting, postural, and action or intention components of hand tremor), and part B of the CRST (five tasks involving handwriting, drawing, and pouring), in the hand contralateral to the thalamotomy.

Thalamotomy patients also reported 46% better quality of life on QUEST at 3 months, compared with 3% better among sham-procedure patients.

There were adverse events in the thalamotomy cohort. At the 3-month follow-up, 36% of subjects experienced gait disturbance, 38% experienced paresthesias or some kind of numbness. The rates of these adverse events dropped to 9% and 14%, respectively, at the 12-month follow-up.

“Deep-brain stimulation is currently the surgical standard for medication-refractory essential tremor [but] a control group of patients undergoing deep-brain stimulation was not included in this trial; the two technologies were not compared,” the authors noted, indicating that such comparison could potentially be the next step for this research.

This study was supported by InSightec, the Focused Ultrasound Foundation, and the Binational Industrial Research and Development Foundation. Dr. Elias disclosed receiving grant support from InSightec and the Focused Ultrasound Foundation. Other coauthors disclosed receiving similar support.

[email protected]

MRI-guided focused ultrasound thalamotomy can significantly mitigate the severity of hand tremors in patients suffering from essential tremor, the most common type of movement disorder, according to a new study published in the New England Journal of Medicine.

“The use of ultrasound energy for the creation of discrete intracranial lesions... has been of interest since the middle of the 20th century,” wrote the investigators, led by W. Jeffrey Elias, MD, of the University of Virginia, Charlottesville. “Prospective pilot trials of focused ultrasound thalamotomy with magnetic resonance imaging (MRI) guidance in patients with essential tremor have shown reductions in hand tremor, improvements in quality of life, and minimal procedural morbidity.”

Courtesy The Ohio State University Wexner Medical Center

The trial enrolled a total of 76 patients with a mean age of 71 years and mean disease duration of nearly 17 years; 68% were men and 75% were white. At a 3:1 ratio, they were randomized into one of two cohorts: one underwent thalamotomy and the other received a “sham” procedure. The subjects were unaware which they received for the first 3 months. The Clinical Rating Scale for Tremor (CRST) and the Quality of Life in Essential Tremor Questionnaire (QUEST) was used to determine the severity of tremors at baseline, and at follow-ups conducted at 1, 3, 6, and 12 months post-procedure (N Engl J Med. 2016;375[8]:730-9).

The trial’s primary outcome of between-group difference in the change in tremor score from baseline to 3 months significantly favored thalamotomy (8.5-point improvement, from 18.1 to 9.6) over the sham procedure (0.2-point improvement, from 16.0 to 15.8). The mean between-group difference in the change in score of 8.3 points at 3 months decreased slightly to 7.2 points at 12 months. The tremor score (range, 0-32) was derived from part A of the CRST (three items: resting, postural, and action or intention components of hand tremor), and part B of the CRST (five tasks involving handwriting, drawing, and pouring), in the hand contralateral to the thalamotomy.

Thalamotomy patients also reported 46% better quality of life on QUEST at 3 months, compared with 3% better among sham-procedure patients.

There were adverse events in the thalamotomy cohort. At the 3-month follow-up, 36% of subjects experienced gait disturbance, 38% experienced paresthesias or some kind of numbness. The rates of these adverse events dropped to 9% and 14%, respectively, at the 12-month follow-up.

“Deep-brain stimulation is currently the surgical standard for medication-refractory essential tremor [but] a control group of patients undergoing deep-brain stimulation was not included in this trial; the two technologies were not compared,” the authors noted, indicating that such comparison could potentially be the next step for this research.

This study was supported by InSightec, the Focused Ultrasound Foundation, and the Binational Industrial Research and Development Foundation. Dr. Elias disclosed receiving grant support from InSightec and the Focused Ultrasound Foundation. Other coauthors disclosed receiving similar support.

[email protected]

MRI-guided focused ultrasound thalamotomy can significantly mitigate the severity of hand tremors in patients suffering from essential tremor, the most common type of movement disorder, according to a new study published in the New England Journal of Medicine.

“The use of ultrasound energy for the creation of discrete intracranial lesions... has been of interest since the middle of the 20th century,” wrote the investigators, led by W. Jeffrey Elias, MD, of the University of Virginia, Charlottesville. “Prospective pilot trials of focused ultrasound thalamotomy with magnetic resonance imaging (MRI) guidance in patients with essential tremor have shown reductions in hand tremor, improvements in quality of life, and minimal procedural morbidity.”

Courtesy The Ohio State University Wexner Medical Center

The trial enrolled a total of 76 patients with a mean age of 71 years and mean disease duration of nearly 17 years; 68% were men and 75% were white. At a 3:1 ratio, they were randomized into one of two cohorts: one underwent thalamotomy and the other received a “sham” procedure. The subjects were unaware which they received for the first 3 months. The Clinical Rating Scale for Tremor (CRST) and the Quality of Life in Essential Tremor Questionnaire (QUEST) was used to determine the severity of tremors at baseline, and at follow-ups conducted at 1, 3, 6, and 12 months post-procedure (N Engl J Med. 2016;375[8]:730-9).

The trial’s primary outcome of between-group difference in the change in tremor score from baseline to 3 months significantly favored thalamotomy (8.5-point improvement, from 18.1 to 9.6) over the sham procedure (0.2-point improvement, from 16.0 to 15.8). The mean between-group difference in the change in score of 8.3 points at 3 months decreased slightly to 7.2 points at 12 months. The tremor score (range, 0-32) was derived from part A of the CRST (three items: resting, postural, and action or intention components of hand tremor), and part B of the CRST (five tasks involving handwriting, drawing, and pouring), in the hand contralateral to the thalamotomy.

Thalamotomy patients also reported 46% better quality of life on QUEST at 3 months, compared with 3% better among sham-procedure patients.

There were adverse events in the thalamotomy cohort. At the 3-month follow-up, 36% of subjects experienced gait disturbance, 38% experienced paresthesias or some kind of numbness. The rates of these adverse events dropped to 9% and 14%, respectively, at the 12-month follow-up.

“Deep-brain stimulation is currently the surgical standard for medication-refractory essential tremor [but] a control group of patients undergoing deep-brain stimulation was not included in this trial; the two technologies were not compared,” the authors noted, indicating that such comparison could potentially be the next step for this research.

This study was supported by InSightec, the Focused Ultrasound Foundation, and the Binational Industrial Research and Development Foundation. Dr. Elias disclosed receiving grant support from InSightec and the Focused Ultrasound Foundation. Other coauthors disclosed receiving similar support.

[email protected]

It is important to step back occasionally to survey where one has been and to plot a new heading. In an online Aug. 10, 2016, release, the New England Journal of Medicine posted two opinion pieces that provide perspective on hospital medicine. As is often the case when journalism presents two opinions, the viewpoints represent opposite ends of a spectrum and the truth lies somewhere in between.

In one essay, Robert Wachter, MD, and Lee Goldman, MD, highlight the successful growth of hospital medicine (N Eng J Med. 2016, Aug 10. doi: 10.1056/NEJMp1607958). In just 2 decades, more than 50,000 physicians have changed their focus to the care of inpatients. The authors state that “many stars had to align” for hospital medicine to grow as rapidly as it has. I would argue instead that many talented leaders of the field have moved heaven and earth to create that alignment and birth this field.

In the other essay, Richard Gunderman, MD, focuses on what he sees as having been lost in this evolution (N Eng J Med. 2016, Aug 10. doi: 10.1056/NEJMp1608289). I believe Dr. Gunderman’s viewpoint nostalgically longs for the good old days and a model of an interpersonal doctor-patient relationship that never really existed for a large portion of the population. If you were wealthy, lived most of your life in one location, and had only intermittent or common diseases, then perhaps you had a trusted general internist to provide your medical care and provide the emotional reassurance that nourished both patient and doctor. But in modern medicine, that scenario is uncommon. With large group practices, there is only a small chance that your personal physician will be on call on the night of your admission to a hospital. The next day, as test results and specialty consults trickle in, that personal physician will be trapped in a busy outpatient clinic and not truly available at hospital bedside in “your moment of greatest need,” as Dr. Gunderman phrased it. When your personal physician finally does make rounds, s/he will find the hospital environment inefficient and repeating the same small mistakes that happened to his/her last patient.

I’ve been writing about and teaching professionalism for years. I agree with Dr. Gunderman about the importance of a doctor-patient relationship. I believe reducing physicians to being automatons in a hospital assembly line would be a bad idea. But this essay’s rose-colored and sienna-colored portrait of that relationship is not helpful guidance in the modern world. Surveyors and navigators need sharp, clear vision.

Trade-offs are being made. Many pediatricians in affluent communities do have the opportunity to establish long-term relationships with families, sometimes for multiple generations of children. Those relationships attract medical students into pediatrics and family medicine. I was fortunate enough to establish many of those relationships when I practiced outpatient pediatrics. During my last interstate move, the man packing the picture frames was amused to find amidst my many diplomas a framed crayon drawing. It was a gift to me from a young patient. I told the mover that I would be sadder to have that drawing damaged than if a diploma was damaged in the move. So he wrapped it with extra padding.

Those bonds established with families make up the emotional sustenance throughout a career that justifies the years of sacrifice spent becoming a physician. There is no doubt that it is easier to form those bonds in outpatient pediatrics. At a community hospital, with 7 days on/7 days off scheduling, I usually provide care for the entire hospitalization of a child. That provides emotional satisfaction for both the parents and for me as a physician in ways that 12-hour shifts usually don’t.

The diminishment of those relationships needs to be acknowledged, but not to the exclusion of what a hospitalist can provide. When I practiced general pediatrics and only admitted 1 or 2 children each week, I was often frustrated by inefficiency and errors in the hospital, but I had little recourse for changing it. As a hospitalist admitting 500 patients per year, I can perform problem solving and devote resources to continuously improve the quality and safety of inpatient care. I provide those improvements to all patients admitted to the hospital, whether they have a medical home or not. That fosters social justice. As a function-over-fashion person, that success is emotionally rewarding, too.

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].

It is important to step back occasionally to survey where one has been and to plot a new heading. In an online Aug. 10, 2016, release, the New England Journal of Medicine posted two opinion pieces that provide perspective on hospital medicine. As is often the case when journalism presents two opinions, the viewpoints represent opposite ends of a spectrum and the truth lies somewhere in between.

In one essay, Robert Wachter, MD, and Lee Goldman, MD, highlight the successful growth of hospital medicine (N Eng J Med. 2016, Aug 10. doi: 10.1056/NEJMp1607958). In just 2 decades, more than 50,000 physicians have changed their focus to the care of inpatients. The authors state that “many stars had to align” for hospital medicine to grow as rapidly as it has. I would argue instead that many talented leaders of the field have moved heaven and earth to create that alignment and birth this field.

In the other essay, Richard Gunderman, MD, focuses on what he sees as having been lost in this evolution (N Eng J Med. 2016, Aug 10. doi: 10.1056/NEJMp1608289). I believe Dr. Gunderman’s viewpoint nostalgically longs for the good old days and a model of an interpersonal doctor-patient relationship that never really existed for a large portion of the population. If you were wealthy, lived most of your life in one location, and had only intermittent or common diseases, then perhaps you had a trusted general internist to provide your medical care and provide the emotional reassurance that nourished both patient and doctor. But in modern medicine, that scenario is uncommon. With large group practices, there is only a small chance that your personal physician will be on call on the night of your admission to a hospital. The next day, as test results and specialty consults trickle in, that personal physician will be trapped in a busy outpatient clinic and not truly available at hospital bedside in “your moment of greatest need,” as Dr. Gunderman phrased it. When your personal physician finally does make rounds, s/he will find the hospital environment inefficient and repeating the same small mistakes that happened to his/her last patient.

I’ve been writing about and teaching professionalism for years. I agree with Dr. Gunderman about the importance of a doctor-patient relationship. I believe reducing physicians to being automatons in a hospital assembly line would be a bad idea. But this essay’s rose-colored and sienna-colored portrait of that relationship is not helpful guidance in the modern world. Surveyors and navigators need sharp, clear vision.

Trade-offs are being made. Many pediatricians in affluent communities do have the opportunity to establish long-term relationships with families, sometimes for multiple generations of children. Those relationships attract medical students into pediatrics and family medicine. I was fortunate enough to establish many of those relationships when I practiced outpatient pediatrics. During my last interstate move, the man packing the picture frames was amused to find amidst my many diplomas a framed crayon drawing. It was a gift to me from a young patient. I told the mover that I would be sadder to have that drawing damaged than if a diploma was damaged in the move. So he wrapped it with extra padding.

Those bonds established with families make up the emotional sustenance throughout a career that justifies the years of sacrifice spent becoming a physician. There is no doubt that it is easier to form those bonds in outpatient pediatrics. At a community hospital, with 7 days on/7 days off scheduling, I usually provide care for the entire hospitalization of a child. That provides emotional satisfaction for both the parents and for me as a physician in ways that 12-hour shifts usually don’t.

The diminishment of those relationships needs to be acknowledged, but not to the exclusion of what a hospitalist can provide. When I practiced general pediatrics and only admitted 1 or 2 children each week, I was often frustrated by inefficiency and errors in the hospital, but I had little recourse for changing it. As a hospitalist admitting 500 patients per year, I can perform problem solving and devote resources to continuously improve the quality and safety of inpatient care. I provide those improvements to all patients admitted to the hospital, whether they have a medical home or not. That fosters social justice. As a function-over-fashion person, that success is emotionally rewarding, too.

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].

It is important to step back occasionally to survey where one has been and to plot a new heading. In an online Aug. 10, 2016, release, the New England Journal of Medicine posted two opinion pieces that provide perspective on hospital medicine. As is often the case when journalism presents two opinions, the viewpoints represent opposite ends of a spectrum and the truth lies somewhere in between.

In one essay, Robert Wachter, MD, and Lee Goldman, MD, highlight the successful growth of hospital medicine (N Eng J Med. 2016, Aug 10. doi: 10.1056/NEJMp1607958). In just 2 decades, more than 50,000 physicians have changed their focus to the care of inpatients. The authors state that “many stars had to align” for hospital medicine to grow as rapidly as it has. I would argue instead that many talented leaders of the field have moved heaven and earth to create that alignment and birth this field.

In the other essay, Richard Gunderman, MD, focuses on what he sees as having been lost in this evolution (N Eng J Med. 2016, Aug 10. doi: 10.1056/NEJMp1608289). I believe Dr. Gunderman’s viewpoint nostalgically longs for the good old days and a model of an interpersonal doctor-patient relationship that never really existed for a large portion of the population. If you were wealthy, lived most of your life in one location, and had only intermittent or common diseases, then perhaps you had a trusted general internist to provide your medical care and provide the emotional reassurance that nourished both patient and doctor. But in modern medicine, that scenario is uncommon. With large group practices, there is only a small chance that your personal physician will be on call on the night of your admission to a hospital. The next day, as test results and specialty consults trickle in, that personal physician will be trapped in a busy outpatient clinic and not truly available at hospital bedside in “your moment of greatest need,” as Dr. Gunderman phrased it. When your personal physician finally does make rounds, s/he will find the hospital environment inefficient and repeating the same small mistakes that happened to his/her last patient.

I’ve been writing about and teaching professionalism for years. I agree with Dr. Gunderman about the importance of a doctor-patient relationship. I believe reducing physicians to being automatons in a hospital assembly line would be a bad idea. But this essay’s rose-colored and sienna-colored portrait of that relationship is not helpful guidance in the modern world. Surveyors and navigators need sharp, clear vision.

Trade-offs are being made. Many pediatricians in affluent communities do have the opportunity to establish long-term relationships with families, sometimes for multiple generations of children. Those relationships attract medical students into pediatrics and family medicine. I was fortunate enough to establish many of those relationships when I practiced outpatient pediatrics. During my last interstate move, the man packing the picture frames was amused to find amidst my many diplomas a framed crayon drawing. It was a gift to me from a young patient. I told the mover that I would be sadder to have that drawing damaged than if a diploma was damaged in the move. So he wrapped it with extra padding.

Those bonds established with families make up the emotional sustenance throughout a career that justifies the years of sacrifice spent becoming a physician. There is no doubt that it is easier to form those bonds in outpatient pediatrics. At a community hospital, with 7 days on/7 days off scheduling, I usually provide care for the entire hospitalization of a child. That provides emotional satisfaction for both the parents and for me as a physician in ways that 12-hour shifts usually don’t.

The diminishment of those relationships needs to be acknowledged, but not to the exclusion of what a hospitalist can provide. When I practiced general pediatrics and only admitted 1 or 2 children each week, I was often frustrated by inefficiency and errors in the hospital, but I had little recourse for changing it. As a hospitalist admitting 500 patients per year, I can perform problem solving and devote resources to continuously improve the quality and safety of inpatient care. I provide those improvements to all patients admitted to the hospital, whether they have a medical home or not. That fosters social justice. As a function-over-fashion person, that success is emotionally rewarding, too.

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].

Slow but steady progress has been made in the management of the major types of gynecologic malignancy, with particularly significant advancements in the treatment of the biggest killer, ovarian cancer. Here we describe how that progress has shaped the current treatment landscape and is forging a path forward.

A therapeutic challenge
More than 90,000 new cases of gynecologic malignancy are diagnosed in the United States each year, and about a third of patients will ultimately succumb to their disease.¹ Five major tumor types make up this large and varied group of cancers: cervical, ovarian, endometrial, vaginal, and vulvar, each with unique biology, etiology, and pathology.²

Most cervical cancers are squamous cell carcinomas and are caused by infection with human papillomaviruses (HPVs), a group of more than 200 related viruses. Development of effective screening methods and prophylactic vaccination have driven a substantial reduction in the incidence of cervical cancer in developed countries, though it remains a major cause of mortality in developing countries.

Click on the PDF icon at the top of this introduction to read the full article.

Slow but steady progress has been made in the management of the major types of gynecologic malignancy, with particularly significant advancements in the treatment of the biggest killer, ovarian cancer. Here we describe how that progress has shaped the current treatment landscape and is forging a path forward.

A therapeutic challenge
More than 90,000 new cases of gynecologic malignancy are diagnosed in the United States each year, and about a third of patients will ultimately succumb to their disease.¹ Five major tumor types make up this large and varied group of cancers: cervical, ovarian, endometrial, vaginal, and vulvar, each with unique biology, etiology, and pathology.²

Most cervical cancers are squamous cell carcinomas and are caused by infection with human papillomaviruses (HPVs), a group of more than 200 related viruses. Development of effective screening methods and prophylactic vaccination have driven a substantial reduction in the incidence of cervical cancer in developed countries, though it remains a major cause of mortality in developing countries.

Click on the PDF icon at the top of this introduction to read the full article.

Slow but steady progress has been made in the management of the major types of gynecologic malignancy, with particularly significant advancements in the treatment of the biggest killer, ovarian cancer. Here we describe how that progress has shaped the current treatment landscape and is forging a path forward.

A therapeutic challenge
More than 90,000 new cases of gynecologic malignancy are diagnosed in the United States each year, and about a third of patients will ultimately succumb to their disease.¹ Five major tumor types make up this large and varied group of cancers: cervical, ovarian, endometrial, vaginal, and vulvar, each with unique biology, etiology, and pathology.²

Most cervical cancers are squamous cell carcinomas and are caused by infection with human papillomaviruses (HPVs), a group of more than 200 related viruses. Development of effective screening methods and prophylactic vaccination have driven a substantial reduction in the incidence of cervical cancer in developed countries, though it remains a major cause of mortality in developing countries.

Click on the PDF icon at the top of this introduction to read the full article.

Click on the PDF icon at the top of this introduction to read the full article.

Click on the PDF icon at the top of this introduction to read the full article.

Click on the PDF icon at the top of this introduction to read the full article.

DURBAN, SOUTH AFRICA – The all-oral, interferon-free, triple- or double-direct-acting antiviral regimens informally known as 3D and 2D proved effective and safe for treatment of chronic hepatitis C due to HCV genotypes 1 and 4 in HIV-coinfected patients taking various antiretroviral combinations in the phase III, multicenter TURQUOISE-1, Part 2 trial, Jürgen K. Rockstroh, MD, reported at the 21st International AIDS Conference.

TURQUOISE-1, Part 2 included 228 patients coinfected with HCV/HIV. Of the 154 with HCV genotype 1a and 44 with genotype 1b, 21 of whom had compensated cirrhosis, 98% of subjects achieved a sustained virologic response (SVR) 12 weeks after conclusion of the 3D regimen, or SVR12, in a modified intent-to-treat analysis. A handful of patients with missing data, or those who stopped treatment for reasons other than virologic failure, were excluded from the analysis.

Bruce Jancin/Frontline Medical News

In the 28 patients coinfected with HCV genotype 4, none of whom had cirrhosis, the modified SVR12 rate was 100%.

The so-called 3D regimen consists of the NS5A inhibitor ombitasvir coformulated in once-daily, fixed-dose fashion with the NS3/4A protease inhibitor paritaprevir boosted with ritonavir, along with twice-daily dasabuvir, a nonnucleoside NS5B RNA polymerase inhibitor. This combination has received Food and Drug Administration approval and is marketed as Viekira Pak for treatment of HCV genotype 1 in HIV-coinfected patients on the basis of the TURQUOISE-1, Part 1a trial (JAMA 2015;313[12]:1223-32). But this study was confined to 63 U.S. patients, and European investigators wanted to see how 3D worked in a larger, more diverse population, explained Dr. Rockstroh, professor of medicine and head of the outpatient HIV clinic at the University of Bonn (Germany).

In TURQUOISE-1, Part 2, patients with HCV genotype 1a without cirrhosis received 12 weeks of the 3D regimen plus ribavirin, while those with compensated cirrhosis got 24 weeks. Patients with genotype 1b received 12 weeks of 3D without ribavirin, regardless of whether or not they had compensated cirrhosis.

Because dasabuvir is ineffective against HCV genotype 4, those patients got 12 weeks of the 2D regimen – the coformulated ombitasvir/paritaprevir/ritonavir – along with ribavirin.

All subjects were on antiretroviral regimens based upon either darunavir (Prezista), atazanavir (Reyataz), raltegravir (Isentress), or dolutegravir (Tivicay). Nearly all (97%) of the patients had an HIV RNA viral load of less than 40 copies/mL at baseline. Those on ritonavir-boosted antiretroviral therapy discontinued the ritonavir and received it instead via their 3D or 2D hepatitis C therapy.

HIV suppression was well maintained throughout the study. Intermittent episodes of HIV viremia affected 4% of participants, but in all cases the peak was less than 200 copies/mL. None of the episodes met standard criteria for HIV genotypic resistance testing, according to Dr. Rockstroh.

In contrast to the former standard therapy consisting of pegylated interferon and ribavirin, which had an SVR of about 30% in HCV/HIV coinfected patients and was fraught with serious side effects, no one discontinued treatment due to adverse events in TURQUOISE-1, Part 2. No cases of hepatic decompensation occurred. The only serious adverse event deemed possibly treatment related was a single case of depression. Mild fatigue, nausea, diarrhea, insomnia, headache, or itching each occurred in 10%-20% of subjects.

As effective antiretroviral therapy enables HIV-infected patients to have a lifespan approaching normal, HCV coinfection has emerged as a major issue. Roughly one-third of HIV-positive individuals are coinfected with HCV, and the rate of death due to HCV-related liver disease in coinfected patients exceeds the rate of death due to HIV. HCV genotype 1 accounts for three-quarters of chronic hepatitis C in the United States, while genotype 4 predominates in Africa, where the bulk of HIV infections occur.

During the AIDS 2016 conference, the Food and Drug Administration approved Viekira XR, an extended-release coformulation of the 3D regimen. Each tablet contains 200 mg of dasabuvir, 8.33 mg of ombitasvir, 50 mg of paritaprevir, and 33.33 mg of ritonavir. The standard dosing is three oral tablets taken once daily.

The TURQUOISE-1, Part 2 trial was sponsored by AbbVie. Dr. Rockstroh is a consultant to AbbVie and seven other pharmaceutical companies.

[email protected]

DURBAN, SOUTH AFRICA – The all-oral, interferon-free, triple- or double-direct-acting antiviral regimens informally known as 3D and 2D proved effective and safe for treatment of chronic hepatitis C due to HCV genotypes 1 and 4 in HIV-coinfected patients taking various antiretroviral combinations in the phase III, multicenter TURQUOISE-1, Part 2 trial, Jürgen K. Rockstroh, MD, reported at the 21st International AIDS Conference.

TURQUOISE-1, Part 2 included 228 patients coinfected with HCV/HIV. Of the 154 with HCV genotype 1a and 44 with genotype 1b, 21 of whom had compensated cirrhosis, 98% of subjects achieved a sustained virologic response (SVR) 12 weeks after conclusion of the 3D regimen, or SVR12, in a modified intent-to-treat analysis. A handful of patients with missing data, or those who stopped treatment for reasons other than virologic failure, were excluded from the analysis.

Bruce Jancin/Frontline Medical News

In the 28 patients coinfected with HCV genotype 4, none of whom had cirrhosis, the modified SVR12 rate was 100%.

The so-called 3D regimen consists of the NS5A inhibitor ombitasvir coformulated in once-daily, fixed-dose fashion with the NS3/4A protease inhibitor paritaprevir boosted with ritonavir, along with twice-daily dasabuvir, a nonnucleoside NS5B RNA polymerase inhibitor. This combination has received Food and Drug Administration approval and is marketed as Viekira Pak for treatment of HCV genotype 1 in HIV-coinfected patients on the basis of the TURQUOISE-1, Part 1a trial (JAMA 2015;313[12]:1223-32). But this study was confined to 63 U.S. patients, and European investigators wanted to see how 3D worked in a larger, more diverse population, explained Dr. Rockstroh, professor of medicine and head of the outpatient HIV clinic at the University of Bonn (Germany).

In TURQUOISE-1, Part 2, patients with HCV genotype 1a without cirrhosis received 12 weeks of the 3D regimen plus ribavirin, while those with compensated cirrhosis got 24 weeks. Patients with genotype 1b received 12 weeks of 3D without ribavirin, regardless of whether or not they had compensated cirrhosis.

Because dasabuvir is ineffective against HCV genotype 4, those patients got 12 weeks of the 2D regimen – the coformulated ombitasvir/paritaprevir/ritonavir – along with ribavirin.

All subjects were on antiretroviral regimens based upon either darunavir (Prezista), atazanavir (Reyataz), raltegravir (Isentress), or dolutegravir (Tivicay). Nearly all (97%) of the patients had an HIV RNA viral load of less than 40 copies/mL at baseline. Those on ritonavir-boosted antiretroviral therapy discontinued the ritonavir and received it instead via their 3D or 2D hepatitis C therapy.

HIV suppression was well maintained throughout the study. Intermittent episodes of HIV viremia affected 4% of participants, but in all cases the peak was less than 200 copies/mL. None of the episodes met standard criteria for HIV genotypic resistance testing, according to Dr. Rockstroh.

In contrast to the former standard therapy consisting of pegylated interferon and ribavirin, which had an SVR of about 30% in HCV/HIV coinfected patients and was fraught with serious side effects, no one discontinued treatment due to adverse events in TURQUOISE-1, Part 2. No cases of hepatic decompensation occurred. The only serious adverse event deemed possibly treatment related was a single case of depression. Mild fatigue, nausea, diarrhea, insomnia, headache, or itching each occurred in 10%-20% of subjects.

As effective antiretroviral therapy enables HIV-infected patients to have a lifespan approaching normal, HCV coinfection has emerged as a major issue. Roughly one-third of HIV-positive individuals are coinfected with HCV, and the rate of death due to HCV-related liver disease in coinfected patients exceeds the rate of death due to HIV. HCV genotype 1 accounts for three-quarters of chronic hepatitis C in the United States, while genotype 4 predominates in Africa, where the bulk of HIV infections occur.

During the AIDS 2016 conference, the Food and Drug Administration approved Viekira XR, an extended-release coformulation of the 3D regimen. Each tablet contains 200 mg of dasabuvir, 8.33 mg of ombitasvir, 50 mg of paritaprevir, and 33.33 mg of ritonavir. The standard dosing is three oral tablets taken once daily.

The TURQUOISE-1, Part 2 trial was sponsored by AbbVie. Dr. Rockstroh is a consultant to AbbVie and seven other pharmaceutical companies.

[email protected]

DURBAN, SOUTH AFRICA – The all-oral, interferon-free, triple- or double-direct-acting antiviral regimens informally known as 3D and 2D proved effective and safe for treatment of chronic hepatitis C due to HCV genotypes 1 and 4 in HIV-coinfected patients taking various antiretroviral combinations in the phase III, multicenter TURQUOISE-1, Part 2 trial, Jürgen K. Rockstroh, MD, reported at the 21st International AIDS Conference.

TURQUOISE-1, Part 2 included 228 patients coinfected with HCV/HIV. Of the 154 with HCV genotype 1a and 44 with genotype 1b, 21 of whom had compensated cirrhosis, 98% of subjects achieved a sustained virologic response (SVR) 12 weeks after conclusion of the 3D regimen, or SVR12, in a modified intent-to-treat analysis. A handful of patients with missing data, or those who stopped treatment for reasons other than virologic failure, were excluded from the analysis.

Bruce Jancin/Frontline Medical News

In the 28 patients coinfected with HCV genotype 4, none of whom had cirrhosis, the modified SVR12 rate was 100%.

The so-called 3D regimen consists of the NS5A inhibitor ombitasvir coformulated in once-daily, fixed-dose fashion with the NS3/4A protease inhibitor paritaprevir boosted with ritonavir, along with twice-daily dasabuvir, a nonnucleoside NS5B RNA polymerase inhibitor. This combination has received Food and Drug Administration approval and is marketed as Viekira Pak for treatment of HCV genotype 1 in HIV-coinfected patients on the basis of the TURQUOISE-1, Part 1a trial (JAMA 2015;313[12]:1223-32). But this study was confined to 63 U.S. patients, and European investigators wanted to see how 3D worked in a larger, more diverse population, explained Dr. Rockstroh, professor of medicine and head of the outpatient HIV clinic at the University of Bonn (Germany).

In TURQUOISE-1, Part 2, patients with HCV genotype 1a without cirrhosis received 12 weeks of the 3D regimen plus ribavirin, while those with compensated cirrhosis got 24 weeks. Patients with genotype 1b received 12 weeks of 3D without ribavirin, regardless of whether or not they had compensated cirrhosis.

Because dasabuvir is ineffective against HCV genotype 4, those patients got 12 weeks of the 2D regimen – the coformulated ombitasvir/paritaprevir/ritonavir – along with ribavirin.

All subjects were on antiretroviral regimens based upon either darunavir (Prezista), atazanavir (Reyataz), raltegravir (Isentress), or dolutegravir (Tivicay). Nearly all (97%) of the patients had an HIV RNA viral load of less than 40 copies/mL at baseline. Those on ritonavir-boosted antiretroviral therapy discontinued the ritonavir and received it instead via their 3D or 2D hepatitis C therapy.

HIV suppression was well maintained throughout the study. Intermittent episodes of HIV viremia affected 4% of participants, but in all cases the peak was less than 200 copies/mL. None of the episodes met standard criteria for HIV genotypic resistance testing, according to Dr. Rockstroh.

In contrast to the former standard therapy consisting of pegylated interferon and ribavirin, which had an SVR of about 30% in HCV/HIV coinfected patients and was fraught with serious side effects, no one discontinued treatment due to adverse events in TURQUOISE-1, Part 2. No cases of hepatic decompensation occurred. The only serious adverse event deemed possibly treatment related was a single case of depression. Mild fatigue, nausea, diarrhea, insomnia, headache, or itching each occurred in 10%-20% of subjects.

As effective antiretroviral therapy enables HIV-infected patients to have a lifespan approaching normal, HCV coinfection has emerged as a major issue. Roughly one-third of HIV-positive individuals are coinfected with HCV, and the rate of death due to HCV-related liver disease in coinfected patients exceeds the rate of death due to HIV. HCV genotype 1 accounts for three-quarters of chronic hepatitis C in the United States, while genotype 4 predominates in Africa, where the bulk of HIV infections occur.

During the AIDS 2016 conference, the Food and Drug Administration approved Viekira XR, an extended-release coformulation of the 3D regimen. Each tablet contains 200 mg of dasabuvir, 8.33 mg of ombitasvir, 50 mg of paritaprevir, and 33.33 mg of ritonavir. The standard dosing is three oral tablets taken once daily.

The TURQUOISE-1, Part 2 trial was sponsored by AbbVie. Dr. Rockstroh is a consultant to AbbVie and seven other pharmaceutical companies.

[email protected]

Stromal or mesenchymal tumors account for about 1% of gastrointestinal (GI) tract neoplasms and are divided into 2 main categories: the gastrointestinal stromal tumors (GISTs; 60%- 90% of mesencymal tumors), and the non-GIST neoplasms (10%-30% of mesencymal tumors).¹ The non-GIST neoplasms consist of a heterogenous group of soft-tissue tumors, identical to soft-tissue tumors elsewhere in the body.

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Stromal or mesenchymal tumors account for about 1% of gastrointestinal (GI) tract neoplasms and are divided into 2 main categories: the gastrointestinal stromal tumors (GISTs; 60%- 90% of mesencymal tumors), and the non-GIST neoplasms (10%-30% of mesencymal tumors).¹ The non-GIST neoplasms consist of a heterogenous group of soft-tissue tumors, identical to soft-tissue tumors elsewhere in the body.

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Stromal or mesenchymal tumors account for about 1% of gastrointestinal (GI) tract neoplasms and are divided into 2 main categories: the gastrointestinal stromal tumors (GISTs; 60%- 90% of mesencymal tumors), and the non-GIST neoplasms (10%-30% of mesencymal tumors).¹ The non-GIST neoplasms consist of a heterogenous group of soft-tissue tumors, identical to soft-tissue tumors elsewhere in the body.

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Background Sleep impairment, fatigue, and anxiety are common conditions in cancer survivors. Small studies suggest mindfulness- based interventions may be helpful for cancer-related fatigue.

Objective To evaluate mindfulness-based cancer recovery (MBCR) for cancer survivors who are recovering from chemotherapy or radiation therapy.

Methods 42 cancer survivors who were within 6 months of completion of chemotherapy or radiation were randomized 2:1 to 8 weekly MBCR classes (n = 28) or wait-list control (n = 14). The Pittsburgh Sleep Quality Index (PSQI), Functional Assessment in Cancer Therapy – Fatigue (FACT-F), and 20-item State-Trait Anxiety Inventory (STAI) were used to assess sleep, fatigue, and anxiety at baseline (time of enrollment), at 2 months (on completion of the MBCR course), and 4 months (2 months after completion of the course). 32 of 42 participants participated in an optional blood draw to assess immune function.

Results 79% of the MBCR group attended at least 7 of the 9 MBCR sessions. At the 2-month assessment, sleep quality (PSQI, range 0-21, >5 = poorer sleep quality) in the MBCR group improved from the baseline 8.9 to 6.4, compared with the wait-list group (baseline 7.2 to 7.6); and at 4 months after course completion, it was 6.1 compared with 7.8, respectively (P = .03). There was a non-statistically significant improvement in fatigue (FACIT-F, P = .19). There was a trend toward improvement in the anxiety scores (STAI, range 20-80, higher score = greater anxiety) in the MBCR group compared with the wait-list group at 2 months (31.8 vs 39.4, respectively; P = .07) and 4 months (32.8 vs 40.7; P = .10). Immune function measures were not statistically significant.

Limitations It is possible the psychological support of being in contact with a facilitator and/or other cancer survivors had a beneficial effect in the outcomes of those in the MBCR group.

Conclusion MBCR has a high compliance rate and results in sustained improvements in sleep quality, fatigue, and anxiety. MBCR may be useful for cancer survivors struggling with sleep, fatigue, and anxiety.

Funding Hourglass Fund, Masonic Cancer Center, University of Minnesota; University of Minnesota Foundation (immune function protocol); National Institutes of Health Office of Women’s Health Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) NIH # K12-HD055887.

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Background Sleep impairment, fatigue, and anxiety are common conditions in cancer survivors. Small studies suggest mindfulness- based interventions may be helpful for cancer-related fatigue.

Objective To evaluate mindfulness-based cancer recovery (MBCR) for cancer survivors who are recovering from chemotherapy or radiation therapy.

Methods 42 cancer survivors who were within 6 months of completion of chemotherapy or radiation were randomized 2:1 to 8 weekly MBCR classes (n = 28) or wait-list control (n = 14). The Pittsburgh Sleep Quality Index (PSQI), Functional Assessment in Cancer Therapy – Fatigue (FACT-F), and 20-item State-Trait Anxiety Inventory (STAI) were used to assess sleep, fatigue, and anxiety at baseline (time of enrollment), at 2 months (on completion of the MBCR course), and 4 months (2 months after completion of the course). 32 of 42 participants participated in an optional blood draw to assess immune function.

Results 79% of the MBCR group attended at least 7 of the 9 MBCR sessions. At the 2-month assessment, sleep quality (PSQI, range 0-21, >5 = poorer sleep quality) in the MBCR group improved from the baseline 8.9 to 6.4, compared with the wait-list group (baseline 7.2 to 7.6); and at 4 months after course completion, it was 6.1 compared with 7.8, respectively (P = .03). There was a non-statistically significant improvement in fatigue (FACIT-F, P = .19). There was a trend toward improvement in the anxiety scores (STAI, range 20-80, higher score = greater anxiety) in the MBCR group compared with the wait-list group at 2 months (31.8 vs 39.4, respectively; P = .07) and 4 months (32.8 vs 40.7; P = .10). Immune function measures were not statistically significant.

Limitations It is possible the psychological support of being in contact with a facilitator and/or other cancer survivors had a beneficial effect in the outcomes of those in the MBCR group.

Conclusion MBCR has a high compliance rate and results in sustained improvements in sleep quality, fatigue, and anxiety. MBCR may be useful for cancer survivors struggling with sleep, fatigue, and anxiety.

Funding Hourglass Fund, Masonic Cancer Center, University of Minnesota; University of Minnesota Foundation (immune function protocol); National Institutes of Health Office of Women’s Health Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) NIH # K12-HD055887.

Click on the PDF icon at the top of this introduction to read the full article.

Background Sleep impairment, fatigue, and anxiety are common conditions in cancer survivors. Small studies suggest mindfulness- based interventions may be helpful for cancer-related fatigue.

Objective To evaluate mindfulness-based cancer recovery (MBCR) for cancer survivors who are recovering from chemotherapy or radiation therapy.

Methods 42 cancer survivors who were within 6 months of completion of chemotherapy or radiation were randomized 2:1 to 8 weekly MBCR classes (n = 28) or wait-list control (n = 14). The Pittsburgh Sleep Quality Index (PSQI), Functional Assessment in Cancer Therapy – Fatigue (FACT-F), and 20-item State-Trait Anxiety Inventory (STAI) were used to assess sleep, fatigue, and anxiety at baseline (time of enrollment), at 2 months (on completion of the MBCR course), and 4 months (2 months after completion of the course). 32 of 42 participants participated in an optional blood draw to assess immune function.

Results 79% of the MBCR group attended at least 7 of the 9 MBCR sessions. At the 2-month assessment, sleep quality (PSQI, range 0-21, >5 = poorer sleep quality) in the MBCR group improved from the baseline 8.9 to 6.4, compared with the wait-list group (baseline 7.2 to 7.6); and at 4 months after course completion, it was 6.1 compared with 7.8, respectively (P = .03). There was a non-statistically significant improvement in fatigue (FACIT-F, P = .19). There was a trend toward improvement in the anxiety scores (STAI, range 20-80, higher score = greater anxiety) in the MBCR group compared with the wait-list group at 2 months (31.8 vs 39.4, respectively; P = .07) and 4 months (32.8 vs 40.7; P = .10). Immune function measures were not statistically significant.

Limitations It is possible the psychological support of being in contact with a facilitator and/or other cancer survivors had a beneficial effect in the outcomes of those in the MBCR group.

Conclusion MBCR has a high compliance rate and results in sustained improvements in sleep quality, fatigue, and anxiety. MBCR may be useful for cancer survivors struggling with sleep, fatigue, and anxiety.

Funding Hourglass Fund, Masonic Cancer Center, University of Minnesota; University of Minnesota Foundation (immune function protocol); National Institutes of Health Office of Women’s Health Building Interdisciplinary Research Careers in Women’s Health (BIRCWH) NIH # K12-HD055887.

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A new classification tool helped guide the treatment of bacteremic patients while clinicians awaited antibiotic resistance results, investigators reported.

The clinical decision tree had a positive predictive value of 91% and a negative predictive value of 92% for determining whether certain gram-negative infections produced extended-spectrum beta-lactamase (ESBL), Catherine Goodman, PhD, of the Johns Hopkins Bloomberg School of Public Health, Baltimore, and her associates wrote online in Clinical Infectious Diseases. “These predictions may assist empiric treatment decisions in order to optimize clinical outcomes while reducing administration of overly broad antibiotic agents that can select for further resistance emergence,” they added.

Bacteria that produce ESBL can hydrolyze all broad-spectrum beta-lactam antibiotics except carbapenems. Rapid tests for beta-lactamase genes can shorten the lag time between gram-stain identification and antimicrobial resistance results, but are cost prohibitive for most clinical laboratories and often do not assess ESBL gene groups, the researchers said. To find a way to predict which infections are characterized by ESBL production, they studied adults hospitalized at Johns Hopkins from October 2008 to March 2015 with bloodstream isolates of Klebsiella pneumoniae (40% of patients), Klebsiella oxytoca (4% of patients), and Escherichia coli (56% of patients). Most bacteremias began as urinary tract infections (34% of cases), followed by intra-abdominal infections (24%), catheter-related infections (16%), and biliary infections (14%) (Clin Infect Dis. 2016 Jul 26. doi:10.1093/cid/ciw425).

A total of 194 patients (15%) had bacteremias that produced ESBL, according to the investigators. Using a technique called binary recursive partitioning, they compared these patients with ESBL-negative patients to create a clinical decision tree based on five yes-or-no questions. The tree first asked if the patient had been colonized or infected with ESBL-producing bacteria within 6 months, and if so, whether the patient currently had an indwelling catheter. Patients meeting both criteria had a 92% chance of being ESBL positive. Patients with a recent history of ESBL but no catheter had an 81% chance of being ESBL positive if they were at least 43 years old, but a 75% chance of being ESBL negative if they were under age 43 years.

Among patients with no recent history of ESBL, the decision tree asked about hospitalization in a country with a high ESBL burden and antibiotic therapy during the past 6 months. Patients responding “yes” to both questions had a 100% chance of being ESBL positive. Patients with only the geographic risk factor had a 63% chance of being ESBL negative, and patients with neither risk factor had a 93% chance of being ESBL negative.

The decision tree detected only half of ESBL cases because there was a subgroup with no recent ESBL history or geographic exposure, the investigators noted. “The poor predictive nature of health care–associated variables within this patient subset may suggest a high proportion of community-acquired ESBL infections. Indeed, although risk factors for ESBLs have traditionally focused on the health care setting, increasing reports describe the community as an important ESBL reservoir,” they added. Nonetheless, of 194 patients with ESBL bacteremia, 35% received empiric carbapenem treatment within 6 hours after identification of the bacterial genus and species, the investigators emphasized. “Utilization of the decision tree would have increased ESBL case detection during the empiric treatment window by approximately 50%.”

The National Institutes of Health funded the study. The researchers reported having no conflicts of interest.

A new classification tool helped guide the treatment of bacteremic patients while clinicians awaited antibiotic resistance results, investigators reported.

The clinical decision tree had a positive predictive value of 91% and a negative predictive value of 92% for determining whether certain gram-negative infections produced extended-spectrum beta-lactamase (ESBL), Catherine Goodman, PhD, of the Johns Hopkins Bloomberg School of Public Health, Baltimore, and her associates wrote online in Clinical Infectious Diseases. “These predictions may assist empiric treatment decisions in order to optimize clinical outcomes while reducing administration of overly broad antibiotic agents that can select for further resistance emergence,” they added.

Bacteria that produce ESBL can hydrolyze all broad-spectrum beta-lactam antibiotics except carbapenems. Rapid tests for beta-lactamase genes can shorten the lag time between gram-stain identification and antimicrobial resistance results, but are cost prohibitive for most clinical laboratories and often do not assess ESBL gene groups, the researchers said. To find a way to predict which infections are characterized by ESBL production, they studied adults hospitalized at Johns Hopkins from October 2008 to March 2015 with bloodstream isolates of Klebsiella pneumoniae (40% of patients), Klebsiella oxytoca (4% of patients), and Escherichia coli (56% of patients). Most bacteremias began as urinary tract infections (34% of cases), followed by intra-abdominal infections (24%), catheter-related infections (16%), and biliary infections (14%) (Clin Infect Dis. 2016 Jul 26. doi:10.1093/cid/ciw425).

A total of 194 patients (15%) had bacteremias that produced ESBL, according to the investigators. Using a technique called binary recursive partitioning, they compared these patients with ESBL-negative patients to create a clinical decision tree based on five yes-or-no questions. The tree first asked if the patient had been colonized or infected with ESBL-producing bacteria within 6 months, and if so, whether the patient currently had an indwelling catheter. Patients meeting both criteria had a 92% chance of being ESBL positive. Patients with a recent history of ESBL but no catheter had an 81% chance of being ESBL positive if they were at least 43 years old, but a 75% chance of being ESBL negative if they were under age 43 years.

Among patients with no recent history of ESBL, the decision tree asked about hospitalization in a country with a high ESBL burden and antibiotic therapy during the past 6 months. Patients responding “yes” to both questions had a 100% chance of being ESBL positive. Patients with only the geographic risk factor had a 63% chance of being ESBL negative, and patients with neither risk factor had a 93% chance of being ESBL negative.

The decision tree detected only half of ESBL cases because there was a subgroup with no recent ESBL history or geographic exposure, the investigators noted. “The poor predictive nature of health care–associated variables within this patient subset may suggest a high proportion of community-acquired ESBL infections. Indeed, although risk factors for ESBLs have traditionally focused on the health care setting, increasing reports describe the community as an important ESBL reservoir,” they added. Nonetheless, of 194 patients with ESBL bacteremia, 35% received empiric carbapenem treatment within 6 hours after identification of the bacterial genus and species, the investigators emphasized. “Utilization of the decision tree would have increased ESBL case detection during the empiric treatment window by approximately 50%.”

The National Institutes of Health funded the study. The researchers reported having no conflicts of interest.

A new classification tool helped guide the treatment of bacteremic patients while clinicians awaited antibiotic resistance results, investigators reported.

The clinical decision tree had a positive predictive value of 91% and a negative predictive value of 92% for determining whether certain gram-negative infections produced extended-spectrum beta-lactamase (ESBL), Catherine Goodman, PhD, of the Johns Hopkins Bloomberg School of Public Health, Baltimore, and her associates wrote online in Clinical Infectious Diseases. “These predictions may assist empiric treatment decisions in order to optimize clinical outcomes while reducing administration of overly broad antibiotic agents that can select for further resistance emergence,” they added.

Bacteria that produce ESBL can hydrolyze all broad-spectrum beta-lactam antibiotics except carbapenems. Rapid tests for beta-lactamase genes can shorten the lag time between gram-stain identification and antimicrobial resistance results, but are cost prohibitive for most clinical laboratories and often do not assess ESBL gene groups, the researchers said. To find a way to predict which infections are characterized by ESBL production, they studied adults hospitalized at Johns Hopkins from October 2008 to March 2015 with bloodstream isolates of Klebsiella pneumoniae (40% of patients), Klebsiella oxytoca (4% of patients), and Escherichia coli (56% of patients). Most bacteremias began as urinary tract infections (34% of cases), followed by intra-abdominal infections (24%), catheter-related infections (16%), and biliary infections (14%) (Clin Infect Dis. 2016 Jul 26. doi:10.1093/cid/ciw425).

A total of 194 patients (15%) had bacteremias that produced ESBL, according to the investigators. Using a technique called binary recursive partitioning, they compared these patients with ESBL-negative patients to create a clinical decision tree based on five yes-or-no questions. The tree first asked if the patient had been colonized or infected with ESBL-producing bacteria within 6 months, and if so, whether the patient currently had an indwelling catheter. Patients meeting both criteria had a 92% chance of being ESBL positive. Patients with a recent history of ESBL but no catheter had an 81% chance of being ESBL positive if they were at least 43 years old, but a 75% chance of being ESBL negative if they were under age 43 years.

Among patients with no recent history of ESBL, the decision tree asked about hospitalization in a country with a high ESBL burden and antibiotic therapy during the past 6 months. Patients responding “yes” to both questions had a 100% chance of being ESBL positive. Patients with only the geographic risk factor had a 63% chance of being ESBL negative, and patients with neither risk factor had a 93% chance of being ESBL negative.

The decision tree detected only half of ESBL cases because there was a subgroup with no recent ESBL history or geographic exposure, the investigators noted. “The poor predictive nature of health care–associated variables within this patient subset may suggest a high proportion of community-acquired ESBL infections. Indeed, although risk factors for ESBLs have traditionally focused on the health care setting, increasing reports describe the community as an important ESBL reservoir,” they added. Nonetheless, of 194 patients with ESBL bacteremia, 35% received empiric carbapenem treatment within 6 hours after identification of the bacterial genus and species, the investigators emphasized. “Utilization of the decision tree would have increased ESBL case detection during the empiric treatment window by approximately 50%.”

The National Institutes of Health funded the study. The researchers reported having no conflicts of interest.

Background Reproductive-age women who are undergoing cancer treatment are at risk for heavy menstrual bleeding, unintended pregnancy, and have a contraindication to estrogen-containing products. The incidence of vaginal bleeding and contraception use is not known.

Objective To describe clinical practices regarding menstrual suppression, estimate the incidence of vaginal bleeding complaints, and investigate contraceptive counseling and provision in women undergoing chemotherapy.

Methods We performed a chart review using ICD-9 codes to identify women aged 14-40 years who received chemotherapy at our institution during July 2008-June 2013. Electronic medical records were examined for menstrual suppression therapy, contraception counseling, and abnormal vaginal bleeding.

Results We identified 137 women for this study. 24 (18%) received prophylactic menstrual suppression counseling, of whom 17 (71%) initiated treatment, primarily with combined oral contraceptives, all prescribed by hematologist-oncologists. During the first 6 months of chemotherapy, 36 women (26%) complained of abnormal vaginal bleeding, including 10 women who were on prophylactic treatment. 19 women noted moderate to severe bleeding. 11 (12%) women received contraceptive counseling before chemotherapy, all from hematologist-oncologists; 86 women (63%) initiated chemotherapy without a documented contraceptive method.

Limitations Data were generated from billing codes, so all eligible women may not have been included.

Conclusions Reproductive-age women undergoing chemotherapy may not receive adequate contraception and menstrual suppression counseling. We encourage consulting gynecologists, especially family planning specialists, at the time of cancer diagnosis to support women with decisions about menstrual suppression and contraception.

Funding/sponsorship Society of Family Planning, National Center for Advancing Translational Sciences, National Institutes of Health, Lillian Mae Rapp Research Endowment

Click on the PDF icon at the top of this introduction to read the full article.

Background Reproductive-age women who are undergoing cancer treatment are at risk for heavy menstrual bleeding, unintended pregnancy, and have a contraindication to estrogen-containing products. The incidence of vaginal bleeding and contraception use is not known.

Objective To describe clinical practices regarding menstrual suppression, estimate the incidence of vaginal bleeding complaints, and investigate contraceptive counseling and provision in women undergoing chemotherapy.

Methods We performed a chart review using ICD-9 codes to identify women aged 14-40 years who received chemotherapy at our institution during July 2008-June 2013. Electronic medical records were examined for menstrual suppression therapy, contraception counseling, and abnormal vaginal bleeding.

Results We identified 137 women for this study. 24 (18%) received prophylactic menstrual suppression counseling, of whom 17 (71%) initiated treatment, primarily with combined oral contraceptives, all prescribed by hematologist-oncologists. During the first 6 months of chemotherapy, 36 women (26%) complained of abnormal vaginal bleeding, including 10 women who were on prophylactic treatment. 19 women noted moderate to severe bleeding. 11 (12%) women received contraceptive counseling before chemotherapy, all from hematologist-oncologists; 86 women (63%) initiated chemotherapy without a documented contraceptive method.

Limitations Data were generated from billing codes, so all eligible women may not have been included.

Conclusions Reproductive-age women undergoing chemotherapy may not receive adequate contraception and menstrual suppression counseling. We encourage consulting gynecologists, especially family planning specialists, at the time of cancer diagnosis to support women with decisions about menstrual suppression and contraception.

Funding/sponsorship Society of Family Planning, National Center for Advancing Translational Sciences, National Institutes of Health, Lillian Mae Rapp Research Endowment

Click on the PDF icon at the top of this introduction to read the full article.

Background Reproductive-age women who are undergoing cancer treatment are at risk for heavy menstrual bleeding, unintended pregnancy, and have a contraindication to estrogen-containing products. The incidence of vaginal bleeding and contraception use is not known.

Objective To describe clinical practices regarding menstrual suppression, estimate the incidence of vaginal bleeding complaints, and investigate contraceptive counseling and provision in women undergoing chemotherapy.

Methods We performed a chart review using ICD-9 codes to identify women aged 14-40 years who received chemotherapy at our institution during July 2008-June 2013. Electronic medical records were examined for menstrual suppression therapy, contraception counseling, and abnormal vaginal bleeding.

Results We identified 137 women for this study. 24 (18%) received prophylactic menstrual suppression counseling, of whom 17 (71%) initiated treatment, primarily with combined oral contraceptives, all prescribed by hematologist-oncologists. During the first 6 months of chemotherapy, 36 women (26%) complained of abnormal vaginal bleeding, including 10 women who were on prophylactic treatment. 19 women noted moderate to severe bleeding. 11 (12%) women received contraceptive counseling before chemotherapy, all from hematologist-oncologists; 86 women (63%) initiated chemotherapy without a documented contraceptive method.

Limitations Data were generated from billing codes, so all eligible women may not have been included.

Conclusions Reproductive-age women undergoing chemotherapy may not receive adequate contraception and menstrual suppression counseling. We encourage consulting gynecologists, especially family planning specialists, at the time of cancer diagnosis to support women with decisions about menstrual suppression and contraception.

Funding/sponsorship Society of Family Planning, National Center for Advancing Translational Sciences, National Institutes of Health, Lillian Mae Rapp Research Endowment

Click on the PDF icon at the top of this introduction to read the full article.