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On vacation, my patients go with me
I’m in the process of planning our family vacations for the summer. I do something different from most when on the road: I take my patients with me.
Well, obviously not physically, but I do cover everything, no matter where I am.
Yes, it takes time. In a ritual my family is used to, two to three times a day I’ll call my staff and go over a list of calls that came in, refills needed, and test results. We go back and forth for a bit. For more complicated questions, I may have to wait until I have my laptop, with the charts on it. If there’s an emergency they’ll call me, and if I can’t be reached, they’ll dial up my call partners.
• I know my patients. I think we all feel that way. I’m more comfortable, and I hope they are too, with the doc who knows them making the decisions.
• My call partners don’t know them. We’re all in solo practice. They don’t have access to my charts any more than I do to theirs. That’s an okay arrangement for a weekend call, but not 2 weeks.
• No surprises. I know that I’m not going to be coming home to a pile of MRI and lab reports that I need to review and act on. If my patient was in the ER or admitted, I spoke to the physician handling it.
A long time ago, when I first started out, I asked another neurologist in my building to cover for me when I was leaving town. I didn’t know him very well, but I was still learning the ropes. He said fine.
When I came home, I found he’d actually “poached” several who’d called, having them come in and convincing them to switch doctors. He’d also changed medications on well-controlled epilepsy and migraine patients who’d needed refills, leaving me to deal with the complications of it when I returned.
Granted, I’ve since learned that he was unusual in that degree, but it really rattled me. I decided I’d rather handle things on my own from then on.
This isn’t an easy decision, but I’m glad I do it. I come home to an office with no surprises, no test results piled up to review, no medication changes that I look at and wonder about.
Does it ruin my vacation? Not at all. Yes, it’s 30-60 minutes out of each day that I have to spend with my office, but I think it’s worth it. It’s peace of mind for me, my staff, and my patients, at least as much as you can ever have in this field.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
[polldaddy:9696724]
I’m in the process of planning our family vacations for the summer. I do something different from most when on the road: I take my patients with me.
Well, obviously not physically, but I do cover everything, no matter where I am.
Yes, it takes time. In a ritual my family is used to, two to three times a day I’ll call my staff and go over a list of calls that came in, refills needed, and test results. We go back and forth for a bit. For more complicated questions, I may have to wait until I have my laptop, with the charts on it. If there’s an emergency they’ll call me, and if I can’t be reached, they’ll dial up my call partners.
• I know my patients. I think we all feel that way. I’m more comfortable, and I hope they are too, with the doc who knows them making the decisions.
• My call partners don’t know them. We’re all in solo practice. They don’t have access to my charts any more than I do to theirs. That’s an okay arrangement for a weekend call, but not 2 weeks.
• No surprises. I know that I’m not going to be coming home to a pile of MRI and lab reports that I need to review and act on. If my patient was in the ER or admitted, I spoke to the physician handling it.
A long time ago, when I first started out, I asked another neurologist in my building to cover for me when I was leaving town. I didn’t know him very well, but I was still learning the ropes. He said fine.
When I came home, I found he’d actually “poached” several who’d called, having them come in and convincing them to switch doctors. He’d also changed medications on well-controlled epilepsy and migraine patients who’d needed refills, leaving me to deal with the complications of it when I returned.
Granted, I’ve since learned that he was unusual in that degree, but it really rattled me. I decided I’d rather handle things on my own from then on.
This isn’t an easy decision, but I’m glad I do it. I come home to an office with no surprises, no test results piled up to review, no medication changes that I look at and wonder about.
Does it ruin my vacation? Not at all. Yes, it’s 30-60 minutes out of each day that I have to spend with my office, but I think it’s worth it. It’s peace of mind for me, my staff, and my patients, at least as much as you can ever have in this field.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
[polldaddy:9696724]
I’m in the process of planning our family vacations for the summer. I do something different from most when on the road: I take my patients with me.
Well, obviously not physically, but I do cover everything, no matter where I am.
Yes, it takes time. In a ritual my family is used to, two to three times a day I’ll call my staff and go over a list of calls that came in, refills needed, and test results. We go back and forth for a bit. For more complicated questions, I may have to wait until I have my laptop, with the charts on it. If there’s an emergency they’ll call me, and if I can’t be reached, they’ll dial up my call partners.
• I know my patients. I think we all feel that way. I’m more comfortable, and I hope they are too, with the doc who knows them making the decisions.
• My call partners don’t know them. We’re all in solo practice. They don’t have access to my charts any more than I do to theirs. That’s an okay arrangement for a weekend call, but not 2 weeks.
• No surprises. I know that I’m not going to be coming home to a pile of MRI and lab reports that I need to review and act on. If my patient was in the ER or admitted, I spoke to the physician handling it.
A long time ago, when I first started out, I asked another neurologist in my building to cover for me when I was leaving town. I didn’t know him very well, but I was still learning the ropes. He said fine.
When I came home, I found he’d actually “poached” several who’d called, having them come in and convincing them to switch doctors. He’d also changed medications on well-controlled epilepsy and migraine patients who’d needed refills, leaving me to deal with the complications of it when I returned.
Granted, I’ve since learned that he was unusual in that degree, but it really rattled me. I decided I’d rather handle things on my own from then on.
This isn’t an easy decision, but I’m glad I do it. I come home to an office with no surprises, no test results piled up to review, no medication changes that I look at and wonder about.
Does it ruin my vacation? Not at all. Yes, it’s 30-60 minutes out of each day that I have to spend with my office, but I think it’s worth it. It’s peace of mind for me, my staff, and my patients, at least as much as you can ever have in this field.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
[polldaddy:9696724]
Oral immunotherapy induced wheat allergy tolerance
ATLANTA – Oral immunotherapy with wheat gluten flour decreased wheat reactions in some allergic patients, according to a trial reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
Wheat allergy is fairly common in young children; most people outgrow it. For some, though, it remains a dangerous problem, especially because wheat is almost impossible to avoid, said senior investigator Hugh Sampson, MD, the Kurt Hirschhorn Professor of Pediatrics at the Icahn School of Medicine at Mount Sinai and director of the Jaffe Food Allergy Institute at Mount Sinai Hospital, New York.
For example, one of the study subjects stopped for a bite on the way to the clinic. “He thought he ate a wheat-free breakfast but ended up arriving with anaphylaxis,” the physician said.
Gluten is the protein-rich allergenic part of wheat; using gluten flour instead of regular flour allowed for smaller, more convenient doses. It was sprinkled over applesauce and other foods. Twelve of the 23 gluten flour subjects (52%), but no one in the placebo group, tolerated a challenge of 4,443 mg at 1 year.
Next, placebo subjects were started on their own gluten flour regimen, but they shot for a higher maximum dose of 3,870 mg/day. The original gluten group stayed on their dose, a maximum of 1,445 mg/day.
The higher dose was more effective at 2-year follow-up; 7 of 23 patients (30%) in the 1,445-mg group tolerated a challenge of 7,443 mg at 2 years, versus 12 of 21 patients (57%) in the 3,870-mg group.
Just over 10% of the doses triggered adverse reactions. Most of the reactions were mild – itching in the throat or mouth, nausea, and the like – but epinephrine was needed after 0.05% of the doses. The adverse reaction rate was similar to that with other forms of oral immunotherapy, and there were no statistically significant differences in the number of reactions between the low- and high-dose gluten groups.
For anyone who reads the study and thinks about running to the grocery store for gluten flour, Dr. Sampson cautioned against it. There’s no Food and Drug Administration–approved product, and, more importantly, “you can run into [serious medical] problems” if, for instance, immunotherapy triggers anaphylaxis with too much exercise afterward.
The study “has nothing to do with” the kind of gluten intolerance that’s led to an explosion in gluten-free products in recent years, he said. “Our study was directed at IgE-mediated reactions. Celiac disease has a very different mechanism.”
Also, only a few people remained tolerant after being backed off wheat immunotherapy for a couple of months. There’s no such thing as a cure for food allergies at this point.
“We are trying to get people into remission. Nobody yet has demonstrated that you can make a permanent change in somebody [who] is hypersensitive, even to a bee sting,” Dr. Sampson said.
The study results are big enough to protect wheat-allergic people from accidental exposure. In the case of the study subject who reacted to wheat in his breakfast, he probably reacted to far less than 7,443 mg of wheat protein – about the amount in a plate of pasta – before immunotherapy. No one with a wheat allergy is intentionally going to order something like that, Dr. Sampson said.
The next step is industry funding for a larger trial. “These studies are expensive, and we hope somebody will take up the torch. We have to get industry involved,” he said.
Private philanthropies funded the work. Dr. Sampson is chief scientific officer for DBV Technologies, a company developing a patch for peanut allergies.
ATLANTA – Oral immunotherapy with wheat gluten flour decreased wheat reactions in some allergic patients, according to a trial reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
Wheat allergy is fairly common in young children; most people outgrow it. For some, though, it remains a dangerous problem, especially because wheat is almost impossible to avoid, said senior investigator Hugh Sampson, MD, the Kurt Hirschhorn Professor of Pediatrics at the Icahn School of Medicine at Mount Sinai and director of the Jaffe Food Allergy Institute at Mount Sinai Hospital, New York.
For example, one of the study subjects stopped for a bite on the way to the clinic. “He thought he ate a wheat-free breakfast but ended up arriving with anaphylaxis,” the physician said.
Gluten is the protein-rich allergenic part of wheat; using gluten flour instead of regular flour allowed for smaller, more convenient doses. It was sprinkled over applesauce and other foods. Twelve of the 23 gluten flour subjects (52%), but no one in the placebo group, tolerated a challenge of 4,443 mg at 1 year.
Next, placebo subjects were started on their own gluten flour regimen, but they shot for a higher maximum dose of 3,870 mg/day. The original gluten group stayed on their dose, a maximum of 1,445 mg/day.
The higher dose was more effective at 2-year follow-up; 7 of 23 patients (30%) in the 1,445-mg group tolerated a challenge of 7,443 mg at 2 years, versus 12 of 21 patients (57%) in the 3,870-mg group.
Just over 10% of the doses triggered adverse reactions. Most of the reactions were mild – itching in the throat or mouth, nausea, and the like – but epinephrine was needed after 0.05% of the doses. The adverse reaction rate was similar to that with other forms of oral immunotherapy, and there were no statistically significant differences in the number of reactions between the low- and high-dose gluten groups.
For anyone who reads the study and thinks about running to the grocery store for gluten flour, Dr. Sampson cautioned against it. There’s no Food and Drug Administration–approved product, and, more importantly, “you can run into [serious medical] problems” if, for instance, immunotherapy triggers anaphylaxis with too much exercise afterward.
The study “has nothing to do with” the kind of gluten intolerance that’s led to an explosion in gluten-free products in recent years, he said. “Our study was directed at IgE-mediated reactions. Celiac disease has a very different mechanism.”
Also, only a few people remained tolerant after being backed off wheat immunotherapy for a couple of months. There’s no such thing as a cure for food allergies at this point.
“We are trying to get people into remission. Nobody yet has demonstrated that you can make a permanent change in somebody [who] is hypersensitive, even to a bee sting,” Dr. Sampson said.
The study results are big enough to protect wheat-allergic people from accidental exposure. In the case of the study subject who reacted to wheat in his breakfast, he probably reacted to far less than 7,443 mg of wheat protein – about the amount in a plate of pasta – before immunotherapy. No one with a wheat allergy is intentionally going to order something like that, Dr. Sampson said.
The next step is industry funding for a larger trial. “These studies are expensive, and we hope somebody will take up the torch. We have to get industry involved,” he said.
Private philanthropies funded the work. Dr. Sampson is chief scientific officer for DBV Technologies, a company developing a patch for peanut allergies.
ATLANTA – Oral immunotherapy with wheat gluten flour decreased wheat reactions in some allergic patients, according to a trial reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
Wheat allergy is fairly common in young children; most people outgrow it. For some, though, it remains a dangerous problem, especially because wheat is almost impossible to avoid, said senior investigator Hugh Sampson, MD, the Kurt Hirschhorn Professor of Pediatrics at the Icahn School of Medicine at Mount Sinai and director of the Jaffe Food Allergy Institute at Mount Sinai Hospital, New York.
For example, one of the study subjects stopped for a bite on the way to the clinic. “He thought he ate a wheat-free breakfast but ended up arriving with anaphylaxis,” the physician said.
Gluten is the protein-rich allergenic part of wheat; using gluten flour instead of regular flour allowed for smaller, more convenient doses. It was sprinkled over applesauce and other foods. Twelve of the 23 gluten flour subjects (52%), but no one in the placebo group, tolerated a challenge of 4,443 mg at 1 year.
Next, placebo subjects were started on their own gluten flour regimen, but they shot for a higher maximum dose of 3,870 mg/day. The original gluten group stayed on their dose, a maximum of 1,445 mg/day.
The higher dose was more effective at 2-year follow-up; 7 of 23 patients (30%) in the 1,445-mg group tolerated a challenge of 7,443 mg at 2 years, versus 12 of 21 patients (57%) in the 3,870-mg group.
Just over 10% of the doses triggered adverse reactions. Most of the reactions were mild – itching in the throat or mouth, nausea, and the like – but epinephrine was needed after 0.05% of the doses. The adverse reaction rate was similar to that with other forms of oral immunotherapy, and there were no statistically significant differences in the number of reactions between the low- and high-dose gluten groups.
For anyone who reads the study and thinks about running to the grocery store for gluten flour, Dr. Sampson cautioned against it. There’s no Food and Drug Administration–approved product, and, more importantly, “you can run into [serious medical] problems” if, for instance, immunotherapy triggers anaphylaxis with too much exercise afterward.
The study “has nothing to do with” the kind of gluten intolerance that’s led to an explosion in gluten-free products in recent years, he said. “Our study was directed at IgE-mediated reactions. Celiac disease has a very different mechanism.”
Also, only a few people remained tolerant after being backed off wheat immunotherapy for a couple of months. There’s no such thing as a cure for food allergies at this point.
“We are trying to get people into remission. Nobody yet has demonstrated that you can make a permanent change in somebody [who] is hypersensitive, even to a bee sting,” Dr. Sampson said.
The study results are big enough to protect wheat-allergic people from accidental exposure. In the case of the study subject who reacted to wheat in his breakfast, he probably reacted to far less than 7,443 mg of wheat protein – about the amount in a plate of pasta – before immunotherapy. No one with a wheat allergy is intentionally going to order something like that, Dr. Sampson said.
The next step is industry funding for a larger trial. “These studies are expensive, and we hope somebody will take up the torch. We have to get industry involved,” he said.
Private philanthropies funded the work. Dr. Sampson is chief scientific officer for DBV Technologies, a company developing a patch for peanut allergies.
AT 2017 AAAAI ANNUAL MEETING
Key clinical point:
Major finding: Twelve of the 23 gluten flour subjects (52%), but no one in the placebo group, tolerated a challenge dose of 4,443 mg at 1 year.
Data source: A randomized trial of 46 wheat-allergic patients.
Disclosures: Private philanthropies funded the work. The senior investigator is chief scientific officer for DBV Technologies, a company developing a patch for peanut allergies.
FDA approves ribociclib for HR+, HER2– advanced breast cancer
The Food and Drug Administration has approved ribociclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
Overall survival data is immature but approval was based on improvement in progression-free survival (PFS) among 334 women randomized to receive ribociclib plus letrozole compared to 334 women randomized to receive placebo plus letrozole in phase III MONALEESA-2 (hazard ratio, 0.556; 95% CI: 0.429, 0.720; P less than .0001).
Ribociclib 600 mg or placebo was administered orally once daily for 21 consecutive days, followed by 7 days off, with letrozole 2.5 mg administered orally once daily for 28 days. All patients were postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer who received no prior therapy for advanced disease. Treatment continued until disease progression or unacceptable toxicity,
The most common adverse reactions in patients taking ribociclib were neutropenia, nausea, fatigue, diarrhea, leukopenia, alopecia, vomiting, constipation, headache, and back pain. The most common grade 3 or 4 adverse reactions were neutropenia, leukopenia, abnormal liver function tests, lymphopenia, and vomiting. Ribociclib has been shown to prolong the QT interval in a concentration-dependent manner, the FDA warns.
Ribociclib is the second CDK4/6 inhibitor to receive approval for advanced breast cancer, following the accelerated approval of palbociclib (Ibrance) plus letrozole (Femara) as a first-line treatment for postmenopausal women with ER-postive, HER2-negative metastatic breast cancer in 2015. The FDA expanded the indication for fulvestrant to include use in combination with palbociclib in 2016.
Phase II trial data indicating activity of a third CDK 4/6 inhibitor, abemaciclib, in this patient population was presented at the 2016 ASCO Annual Meeting.
The recommended starting dose of ribociclib is 600 mg orally (three 200-mg tablets) taken once daily with or without food for 21 consecutive days followed by 7 days off treatment.
Full prescribing information for ribociclib is available here.
Ribociclib is being marketed as Kisqali by Novartis Pharmaceuticals Corp.
[email protected]
On Twitter @NikolaidesLaura
The Food and Drug Administration has approved ribociclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
Overall survival data is immature but approval was based on improvement in progression-free survival (PFS) among 334 women randomized to receive ribociclib plus letrozole compared to 334 women randomized to receive placebo plus letrozole in phase III MONALEESA-2 (hazard ratio, 0.556; 95% CI: 0.429, 0.720; P less than .0001).
Ribociclib 600 mg or placebo was administered orally once daily for 21 consecutive days, followed by 7 days off, with letrozole 2.5 mg administered orally once daily for 28 days. All patients were postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer who received no prior therapy for advanced disease. Treatment continued until disease progression or unacceptable toxicity,
The most common adverse reactions in patients taking ribociclib were neutropenia, nausea, fatigue, diarrhea, leukopenia, alopecia, vomiting, constipation, headache, and back pain. The most common grade 3 or 4 adverse reactions were neutropenia, leukopenia, abnormal liver function tests, lymphopenia, and vomiting. Ribociclib has been shown to prolong the QT interval in a concentration-dependent manner, the FDA warns.
Ribociclib is the second CDK4/6 inhibitor to receive approval for advanced breast cancer, following the accelerated approval of palbociclib (Ibrance) plus letrozole (Femara) as a first-line treatment for postmenopausal women with ER-postive, HER2-negative metastatic breast cancer in 2015. The FDA expanded the indication for fulvestrant to include use in combination with palbociclib in 2016.
Phase II trial data indicating activity of a third CDK 4/6 inhibitor, abemaciclib, in this patient population was presented at the 2016 ASCO Annual Meeting.
The recommended starting dose of ribociclib is 600 mg orally (three 200-mg tablets) taken once daily with or without food for 21 consecutive days followed by 7 days off treatment.
Full prescribing information for ribociclib is available here.
Ribociclib is being marketed as Kisqali by Novartis Pharmaceuticals Corp.
[email protected]
On Twitter @NikolaidesLaura
The Food and Drug Administration has approved ribociclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
Overall survival data is immature but approval was based on improvement in progression-free survival (PFS) among 334 women randomized to receive ribociclib plus letrozole compared to 334 women randomized to receive placebo plus letrozole in phase III MONALEESA-2 (hazard ratio, 0.556; 95% CI: 0.429, 0.720; P less than .0001).
Ribociclib 600 mg or placebo was administered orally once daily for 21 consecutive days, followed by 7 days off, with letrozole 2.5 mg administered orally once daily for 28 days. All patients were postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer who received no prior therapy for advanced disease. Treatment continued until disease progression or unacceptable toxicity,
The most common adverse reactions in patients taking ribociclib were neutropenia, nausea, fatigue, diarrhea, leukopenia, alopecia, vomiting, constipation, headache, and back pain. The most common grade 3 or 4 adverse reactions were neutropenia, leukopenia, abnormal liver function tests, lymphopenia, and vomiting. Ribociclib has been shown to prolong the QT interval in a concentration-dependent manner, the FDA warns.
Ribociclib is the second CDK4/6 inhibitor to receive approval for advanced breast cancer, following the accelerated approval of palbociclib (Ibrance) plus letrozole (Femara) as a first-line treatment for postmenopausal women with ER-postive, HER2-negative metastatic breast cancer in 2015. The FDA expanded the indication for fulvestrant to include use in combination with palbociclib in 2016.
Phase II trial data indicating activity of a third CDK 4/6 inhibitor, abemaciclib, in this patient population was presented at the 2016 ASCO Annual Meeting.
The recommended starting dose of ribociclib is 600 mg orally (three 200-mg tablets) taken once daily with or without food for 21 consecutive days followed by 7 days off treatment.
Full prescribing information for ribociclib is available here.
Ribociclib is being marketed as Kisqali by Novartis Pharmaceuticals Corp.
[email protected]
On Twitter @NikolaidesLaura
Isolated tumor cells did not predict progression in endometrial cancer
NATIONAL HARBOR, MD. – Patients with endometrial cancer should not receive adjuvant chemotherapy or radiotherapy solely because they have isolated tumor cells in their sentinel lymph nodes, Marie Plante, MD, said during an oral presentation at the annual meeting of the Society of Gynecologic Oncology.
In a single-center prospective cohort study, about 96% of patients with endometrial cancer were alive and progression free at 3 years, a rate which resembles those reported for node-negative patients, said Dr. Plante of Laval University, Quebec City. Moreover, all 10 patients who did not receive adjuvant therapy remained alive and progression free during follow-up, she said. “Patients with isolated tumor cells carry an excellent prognosis,” she added. “Adjuvant treatment should be tailored based on uterine factors and histology and not solely on the presence of isolated tumor cells in sentinel lymph nodes.”
Pathologic ultrastaging has boosted the detection of low-volume metastases, which comprise anywhere from 35% to 63% of nodal metastases in patients with endometrial cancer. Clinicians continue to debate management when this low-volume disease consists of isolated tumor cells (ITC), defined as fewer than 200 carcinoma cells found singly or in small clusters. Finding ITC in endometrial cancer is uncommon, and few studies have examined this subgroup, Dr. Plante noted.
She and her associates evaluated 519 patients who underwent hysterectomy, salpingo-oophorectomy, lymphadenectomy, or sentinel lymph node mapping for endometrial cancer at their center between 2010 and 2015. Pathologic ultrastaging identified 31 patients with ITC (6%), of whom 11 patients received adjuvant chemotherapy, 14 received pelvic radiation therapy, and 10 underwent only brachytherapy or observation, with some patients receiving more than one treatment. Another 54 patients in the cohort had metastatic disease, including 43 patients with macrometastasis and 11 with micrometastasis.
Stage, not treatment, predicted progression-free survival (PFS), Dr. Plante emphasized. After a median follow-up period of 29 months, the estimated 3-year rate of PFS was significantly better among patients with ITC (96%), node-negative disease (88%), or micrometastasis (86%) than among those with macrometastasis (59%; P = .001), even though macrometastasis patients received significantly more chemotherapy (P = .0001).
Rates of PFS did not statistically differ between the ITC and node-negative groups, Dr. Plante noted. The single recurrence in an ITC patient involved a 7 cm carcinosarcoma that recurred despite adjuvant chemotherapy and radiation therapy. There were no recurrences among patients with endometrioid histology.
Among ITC patients who received no adjuvant treatment, half had stage IA endometrial cancer and half were stage IB, half were grade 1 and half were grade 2, all had endometrioid histology, and seven (70%) had evidence of lymphovascular space invasion, Dr. Plante said. All remained alive and progression free at follow-up.
Ultrastaging should only be performed if a sentinel lymph node is negative on initial hematoxylin and eosin stain and if there is myoinvasion, commented Nadeem R. Abu-Rustum, MD, chief of the gynecology service at Memorial Sloan Kettering Cancer Center, New York, who was not involved in the study. “Ultrastaging increases positive-node detection by about 8%,” he said during the scientific plenary session at the conference. “Finding positive nodes can change management, and we have to be careful not to overtreat.”
Ongoing research is examining the topography and anatomic location of ITC in sentinel lymph nodes, Dr. Abu-Rustum said. In the meantime, he advised clinicians to consider any ultrastaging result of ITC in context. “When modeling the risk of ITCs, don’t look at them in isolation. Don’t be ‘node-centric,’ ” he advised. “Look at the uterine factors and the overall bigger picture.”
Dr. Plante did not acknowledge external funding sources. Dr. Plante and Dr. Abu-Rustum reported having no conflicts of interest.
NATIONAL HARBOR, MD. – Patients with endometrial cancer should not receive adjuvant chemotherapy or radiotherapy solely because they have isolated tumor cells in their sentinel lymph nodes, Marie Plante, MD, said during an oral presentation at the annual meeting of the Society of Gynecologic Oncology.
In a single-center prospective cohort study, about 96% of patients with endometrial cancer were alive and progression free at 3 years, a rate which resembles those reported for node-negative patients, said Dr. Plante of Laval University, Quebec City. Moreover, all 10 patients who did not receive adjuvant therapy remained alive and progression free during follow-up, she said. “Patients with isolated tumor cells carry an excellent prognosis,” she added. “Adjuvant treatment should be tailored based on uterine factors and histology and not solely on the presence of isolated tumor cells in sentinel lymph nodes.”
Pathologic ultrastaging has boosted the detection of low-volume metastases, which comprise anywhere from 35% to 63% of nodal metastases in patients with endometrial cancer. Clinicians continue to debate management when this low-volume disease consists of isolated tumor cells (ITC), defined as fewer than 200 carcinoma cells found singly or in small clusters. Finding ITC in endometrial cancer is uncommon, and few studies have examined this subgroup, Dr. Plante noted.
She and her associates evaluated 519 patients who underwent hysterectomy, salpingo-oophorectomy, lymphadenectomy, or sentinel lymph node mapping for endometrial cancer at their center between 2010 and 2015. Pathologic ultrastaging identified 31 patients with ITC (6%), of whom 11 patients received adjuvant chemotherapy, 14 received pelvic radiation therapy, and 10 underwent only brachytherapy or observation, with some patients receiving more than one treatment. Another 54 patients in the cohort had metastatic disease, including 43 patients with macrometastasis and 11 with micrometastasis.
Stage, not treatment, predicted progression-free survival (PFS), Dr. Plante emphasized. After a median follow-up period of 29 months, the estimated 3-year rate of PFS was significantly better among patients with ITC (96%), node-negative disease (88%), or micrometastasis (86%) than among those with macrometastasis (59%; P = .001), even though macrometastasis patients received significantly more chemotherapy (P = .0001).
Rates of PFS did not statistically differ between the ITC and node-negative groups, Dr. Plante noted. The single recurrence in an ITC patient involved a 7 cm carcinosarcoma that recurred despite adjuvant chemotherapy and radiation therapy. There were no recurrences among patients with endometrioid histology.
Among ITC patients who received no adjuvant treatment, half had stage IA endometrial cancer and half were stage IB, half were grade 1 and half were grade 2, all had endometrioid histology, and seven (70%) had evidence of lymphovascular space invasion, Dr. Plante said. All remained alive and progression free at follow-up.
Ultrastaging should only be performed if a sentinel lymph node is negative on initial hematoxylin and eosin stain and if there is myoinvasion, commented Nadeem R. Abu-Rustum, MD, chief of the gynecology service at Memorial Sloan Kettering Cancer Center, New York, who was not involved in the study. “Ultrastaging increases positive-node detection by about 8%,” he said during the scientific plenary session at the conference. “Finding positive nodes can change management, and we have to be careful not to overtreat.”
Ongoing research is examining the topography and anatomic location of ITC in sentinel lymph nodes, Dr. Abu-Rustum said. In the meantime, he advised clinicians to consider any ultrastaging result of ITC in context. “When modeling the risk of ITCs, don’t look at them in isolation. Don’t be ‘node-centric,’ ” he advised. “Look at the uterine factors and the overall bigger picture.”
Dr. Plante did not acknowledge external funding sources. Dr. Plante and Dr. Abu-Rustum reported having no conflicts of interest.
NATIONAL HARBOR, MD. – Patients with endometrial cancer should not receive adjuvant chemotherapy or radiotherapy solely because they have isolated tumor cells in their sentinel lymph nodes, Marie Plante, MD, said during an oral presentation at the annual meeting of the Society of Gynecologic Oncology.
In a single-center prospective cohort study, about 96% of patients with endometrial cancer were alive and progression free at 3 years, a rate which resembles those reported for node-negative patients, said Dr. Plante of Laval University, Quebec City. Moreover, all 10 patients who did not receive adjuvant therapy remained alive and progression free during follow-up, she said. “Patients with isolated tumor cells carry an excellent prognosis,” she added. “Adjuvant treatment should be tailored based on uterine factors and histology and not solely on the presence of isolated tumor cells in sentinel lymph nodes.”
Pathologic ultrastaging has boosted the detection of low-volume metastases, which comprise anywhere from 35% to 63% of nodal metastases in patients with endometrial cancer. Clinicians continue to debate management when this low-volume disease consists of isolated tumor cells (ITC), defined as fewer than 200 carcinoma cells found singly or in small clusters. Finding ITC in endometrial cancer is uncommon, and few studies have examined this subgroup, Dr. Plante noted.
She and her associates evaluated 519 patients who underwent hysterectomy, salpingo-oophorectomy, lymphadenectomy, or sentinel lymph node mapping for endometrial cancer at their center between 2010 and 2015. Pathologic ultrastaging identified 31 patients with ITC (6%), of whom 11 patients received adjuvant chemotherapy, 14 received pelvic radiation therapy, and 10 underwent only brachytherapy or observation, with some patients receiving more than one treatment. Another 54 patients in the cohort had metastatic disease, including 43 patients with macrometastasis and 11 with micrometastasis.
Stage, not treatment, predicted progression-free survival (PFS), Dr. Plante emphasized. After a median follow-up period of 29 months, the estimated 3-year rate of PFS was significantly better among patients with ITC (96%), node-negative disease (88%), or micrometastasis (86%) than among those with macrometastasis (59%; P = .001), even though macrometastasis patients received significantly more chemotherapy (P = .0001).
Rates of PFS did not statistically differ between the ITC and node-negative groups, Dr. Plante noted. The single recurrence in an ITC patient involved a 7 cm carcinosarcoma that recurred despite adjuvant chemotherapy and radiation therapy. There were no recurrences among patients with endometrioid histology.
Among ITC patients who received no adjuvant treatment, half had stage IA endometrial cancer and half were stage IB, half were grade 1 and half were grade 2, all had endometrioid histology, and seven (70%) had evidence of lymphovascular space invasion, Dr. Plante said. All remained alive and progression free at follow-up.
Ultrastaging should only be performed if a sentinel lymph node is negative on initial hematoxylin and eosin stain and if there is myoinvasion, commented Nadeem R. Abu-Rustum, MD, chief of the gynecology service at Memorial Sloan Kettering Cancer Center, New York, who was not involved in the study. “Ultrastaging increases positive-node detection by about 8%,” he said during the scientific plenary session at the conference. “Finding positive nodes can change management, and we have to be careful not to overtreat.”
Ongoing research is examining the topography and anatomic location of ITC in sentinel lymph nodes, Dr. Abu-Rustum said. In the meantime, he advised clinicians to consider any ultrastaging result of ITC in context. “When modeling the risk of ITCs, don’t look at them in isolation. Don’t be ‘node-centric,’ ” he advised. “Look at the uterine factors and the overall bigger picture.”
Dr. Plante did not acknowledge external funding sources. Dr. Plante and Dr. Abu-Rustum reported having no conflicts of interest.
AT THE ANNUAL MEETING ON WOMEN’S CANCER
Key clinical point: For patients with endometrial cancer, isolated tumor cells in sentinel lymph nodes did not lead to disease progression and were not an indication for adjuvant treatments.
Major finding: At 3 years, the estimated rate of progression-free survival was 100% among patients who underwent only pelvic brachytherapy or observation.
Data source: A single-center prospective study of 519 patients undergoing hysterectomy, salpingo-oophorectomy, lymphadenectomy, and sentinel lymph node mapping for endometrial cancer, including 31 patients with isolated tumor cells identified in sentinel lymph nodes.
Disclosures: Dr. Plante did not report having external funding sources. Dr. Plante and Dr. Abu-Rustum had no disclosures.
More pushback from docs after CBO scores GOP health care plan
Physician groups continue to push back against a Republican plan to repeal and replace the Affordable Care Act following a Congressional Budget Office analysis that showed up to 24 million patients would not be insured under the plan.
According to the CBO analysis, 14 million more patients would become uninsured in the first year of the American Health Care Act than under current law, with most dropping coverage because of the repeal of the ACA’s individual health insurance mandate.
By 2020, an additional 7 million patients would lose coverage largely because of the bill’s rollback of expansion in favor of a per capita allotment to states to cover their Medicaid population.
“In 2026, an estimated 52 million would be uninsured, compared with 28 million who would lack insurance that year under current law,” according to the CBO analysis.
American Medical Association President Andrew Gurman, MD, called the uptick in uninsured “unacceptable.”
“While the Affordable Care Act was an imperfect law, it was a significant improvement on the status quo at the time, and the AMA believes we need continued progress to expand coverage for the uninsured. Unfortunately, the current proposal – as the CBO analysis shows – would result in the most vulnerable population losing their coverage,” Dr. Gurman said in a statement.
Likewise, the American Osteopathic Association voiced its objections to the GOP proposal.
“The AOA urges Congress to halt any further progression of the American Health Care Act as written and take a more comprehensive approach that addresses such systemic issues while providing stability for the insurance marketplace and the millions of Americans who rely on it for coverage,” President Boyd Buser, DO, said in a statement.
According to the CBO analysis, the individual health insurance market “would probably be stable in most areas under either current law or the legislation.” However, there could be large premium increases for some patients, based on age group.
Tom Price, MD, secretary of the Department of Health & Human Services, criticized the CBO projections.
“The CBO report’s coverage numbers defy logic,” he said in a statement. “They project that zeroing out the individual mandate – allowing Americans to choose whether to have insurance – will result in 14 million Americans opting out of coverage in 1 year. For there to be the reductions in coverage they project in just the first year, they assume 5 million Americans on Medicaid will drop off of health insurance for which they pay very little, and another 9 million will stop participating in the individual and employer markets. These types of assumptions do not translate to the real world, and they do not accurately estimate the effects of this bill.”
Rep. Kevin Brady (R-Texas), chairman of the House Ways & Means Committee, also disputed the increase in the uninsured population.
“The American Health Care Act is a dramatic departure from Obamacare, which forced Americans to buy expensive, one-size-fits-all health insurance,” Chairman Brady said in a statement. “Our legislation gives individuals and families the freedom to access health care options that are tailored to the needs, not Washington’s.”
Rep. Brady and Dr. Price also pointed out that the AHCA is just the first step of a three-step process, which will include a review of ACA regulations as well as passage of further legislation aimed at providing high quality care at lower costs. However, those cannot be scored by CBO as those details have yet to be released, the GOP leaders pointed out.
The CBO analysis predicts that premiums for those buying insurance in the individual marketplace would increase of 15%-20% from 2018 to 2019, but starting in 2020, average premiums are expected to decrease from states using federal government funds to help offset costs from high users of health care and more younger people coming into the health insurance market.
“By 2026, average premiums for single policyholders in the nongroup market under the legislation would be roughly 10% lower than under current law,” according to the analysis, although since the law allows for higher premiums for older individuals, the congressional budget watchdog sees the provisions of the AHCA as “substantially reducing premiums for young adults and substantially raising premiums for older people.”
The CBO estimates that enacting this legislation would reduce federal deficits by $337 billion over the 2017-2026 period, mainly from reductions in Medicaid spending and the elimination of the current premium subsidies, though the deficit reduction is somewhat offset by the refundable premium tax credits that replace the ACA’s subsidies.
Physician groups continue to push back against a Republican plan to repeal and replace the Affordable Care Act following a Congressional Budget Office analysis that showed up to 24 million patients would not be insured under the plan.
According to the CBO analysis, 14 million more patients would become uninsured in the first year of the American Health Care Act than under current law, with most dropping coverage because of the repeal of the ACA’s individual health insurance mandate.
By 2020, an additional 7 million patients would lose coverage largely because of the bill’s rollback of expansion in favor of a per capita allotment to states to cover their Medicaid population.
“In 2026, an estimated 52 million would be uninsured, compared with 28 million who would lack insurance that year under current law,” according to the CBO analysis.
American Medical Association President Andrew Gurman, MD, called the uptick in uninsured “unacceptable.”
“While the Affordable Care Act was an imperfect law, it was a significant improvement on the status quo at the time, and the AMA believes we need continued progress to expand coverage for the uninsured. Unfortunately, the current proposal – as the CBO analysis shows – would result in the most vulnerable population losing their coverage,” Dr. Gurman said in a statement.
Likewise, the American Osteopathic Association voiced its objections to the GOP proposal.
“The AOA urges Congress to halt any further progression of the American Health Care Act as written and take a more comprehensive approach that addresses such systemic issues while providing stability for the insurance marketplace and the millions of Americans who rely on it for coverage,” President Boyd Buser, DO, said in a statement.
According to the CBO analysis, the individual health insurance market “would probably be stable in most areas under either current law or the legislation.” However, there could be large premium increases for some patients, based on age group.
Tom Price, MD, secretary of the Department of Health & Human Services, criticized the CBO projections.
“The CBO report’s coverage numbers defy logic,” he said in a statement. “They project that zeroing out the individual mandate – allowing Americans to choose whether to have insurance – will result in 14 million Americans opting out of coverage in 1 year. For there to be the reductions in coverage they project in just the first year, they assume 5 million Americans on Medicaid will drop off of health insurance for which they pay very little, and another 9 million will stop participating in the individual and employer markets. These types of assumptions do not translate to the real world, and they do not accurately estimate the effects of this bill.”
Rep. Kevin Brady (R-Texas), chairman of the House Ways & Means Committee, also disputed the increase in the uninsured population.
“The American Health Care Act is a dramatic departure from Obamacare, which forced Americans to buy expensive, one-size-fits-all health insurance,” Chairman Brady said in a statement. “Our legislation gives individuals and families the freedom to access health care options that are tailored to the needs, not Washington’s.”
Rep. Brady and Dr. Price also pointed out that the AHCA is just the first step of a three-step process, which will include a review of ACA regulations as well as passage of further legislation aimed at providing high quality care at lower costs. However, those cannot be scored by CBO as those details have yet to be released, the GOP leaders pointed out.
The CBO analysis predicts that premiums for those buying insurance in the individual marketplace would increase of 15%-20% from 2018 to 2019, but starting in 2020, average premiums are expected to decrease from states using federal government funds to help offset costs from high users of health care and more younger people coming into the health insurance market.
“By 2026, average premiums for single policyholders in the nongroup market under the legislation would be roughly 10% lower than under current law,” according to the analysis, although since the law allows for higher premiums for older individuals, the congressional budget watchdog sees the provisions of the AHCA as “substantially reducing premiums for young adults and substantially raising premiums for older people.”
The CBO estimates that enacting this legislation would reduce federal deficits by $337 billion over the 2017-2026 period, mainly from reductions in Medicaid spending and the elimination of the current premium subsidies, though the deficit reduction is somewhat offset by the refundable premium tax credits that replace the ACA’s subsidies.
Physician groups continue to push back against a Republican plan to repeal and replace the Affordable Care Act following a Congressional Budget Office analysis that showed up to 24 million patients would not be insured under the plan.
According to the CBO analysis, 14 million more patients would become uninsured in the first year of the American Health Care Act than under current law, with most dropping coverage because of the repeal of the ACA’s individual health insurance mandate.
By 2020, an additional 7 million patients would lose coverage largely because of the bill’s rollback of expansion in favor of a per capita allotment to states to cover their Medicaid population.
“In 2026, an estimated 52 million would be uninsured, compared with 28 million who would lack insurance that year under current law,” according to the CBO analysis.
American Medical Association President Andrew Gurman, MD, called the uptick in uninsured “unacceptable.”
“While the Affordable Care Act was an imperfect law, it was a significant improvement on the status quo at the time, and the AMA believes we need continued progress to expand coverage for the uninsured. Unfortunately, the current proposal – as the CBO analysis shows – would result in the most vulnerable population losing their coverage,” Dr. Gurman said in a statement.
Likewise, the American Osteopathic Association voiced its objections to the GOP proposal.
“The AOA urges Congress to halt any further progression of the American Health Care Act as written and take a more comprehensive approach that addresses such systemic issues while providing stability for the insurance marketplace and the millions of Americans who rely on it for coverage,” President Boyd Buser, DO, said in a statement.
According to the CBO analysis, the individual health insurance market “would probably be stable in most areas under either current law or the legislation.” However, there could be large premium increases for some patients, based on age group.
Tom Price, MD, secretary of the Department of Health & Human Services, criticized the CBO projections.
“The CBO report’s coverage numbers defy logic,” he said in a statement. “They project that zeroing out the individual mandate – allowing Americans to choose whether to have insurance – will result in 14 million Americans opting out of coverage in 1 year. For there to be the reductions in coverage they project in just the first year, they assume 5 million Americans on Medicaid will drop off of health insurance for which they pay very little, and another 9 million will stop participating in the individual and employer markets. These types of assumptions do not translate to the real world, and they do not accurately estimate the effects of this bill.”
Rep. Kevin Brady (R-Texas), chairman of the House Ways & Means Committee, also disputed the increase in the uninsured population.
“The American Health Care Act is a dramatic departure from Obamacare, which forced Americans to buy expensive, one-size-fits-all health insurance,” Chairman Brady said in a statement. “Our legislation gives individuals and families the freedom to access health care options that are tailored to the needs, not Washington’s.”
Rep. Brady and Dr. Price also pointed out that the AHCA is just the first step of a three-step process, which will include a review of ACA regulations as well as passage of further legislation aimed at providing high quality care at lower costs. However, those cannot be scored by CBO as those details have yet to be released, the GOP leaders pointed out.
The CBO analysis predicts that premiums for those buying insurance in the individual marketplace would increase of 15%-20% from 2018 to 2019, but starting in 2020, average premiums are expected to decrease from states using federal government funds to help offset costs from high users of health care and more younger people coming into the health insurance market.
“By 2026, average premiums for single policyholders in the nongroup market under the legislation would be roughly 10% lower than under current law,” according to the analysis, although since the law allows for higher premiums for older individuals, the congressional budget watchdog sees the provisions of the AHCA as “substantially reducing premiums for young adults and substantially raising premiums for older people.”
The CBO estimates that enacting this legislation would reduce federal deficits by $337 billion over the 2017-2026 period, mainly from reductions in Medicaid spending and the elimination of the current premium subsidies, though the deficit reduction is somewhat offset by the refundable premium tax credits that replace the ACA’s subsidies.
VIDEO: Cell-free DNA mutations linked with recurrence of ovarian cancer
NATIONAL HARBOR, MD. – Next-generation sequencing of high-grade serous ovarian tumor specimens taken during interval debulking identified several mutations that matched those in cell-free DNA (cfDNA), Rebecca C. Arend, MD, said at the annual meeting of the Society of Gynecologic Oncology.
Furthermore, three of four patients whose ovarian cancer recurred had mutations in cfDNA that were previously detected in tumors, said Dr. Arend of the University of Alabama at Birmingham.
Researchers continue to search for ways to spare patients with ovarian cancer from serial biopsies, Dr. Arend noted during a video interview. As part of that work, she and her associates performed longitudinal next-generation sequencing of 50 genes in tumor and plasma specimens from 14 patients with high-grade serous ovarian cancer.
Mutations found only in tumors were relatively consistent before and after neoadjuvant chemotherapy, while mutations found only in cell-free DNA varied substantially.
The researchers also sequenced plasma samples from four patients at cancer recurrence. Three patients had at least one mutation that was previously detected in their tumor sample. Implicated genes included PIK3CA, TP53, KIT, and KDR.
Many studies have sought circulating tumor markers that reliably predict tumor recurrence. When it comes to cfDNA, “we are not there yet,” but the work is worthwhile, Dr. Arend stressed. Sequencing tumor and cfDNA specimens from patients at multiple points during their journey might one day help pinpoint mutations that reliably predict cancer recurrence, sparing patients from repeated biopsies and helping them efficiently enter clinical trials that target their specific mutation, she added.
Dr. Arend cited no funding sources and reported having no conflicts of interest.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
NATIONAL HARBOR, MD. – Next-generation sequencing of high-grade serous ovarian tumor specimens taken during interval debulking identified several mutations that matched those in cell-free DNA (cfDNA), Rebecca C. Arend, MD, said at the annual meeting of the Society of Gynecologic Oncology.
Furthermore, three of four patients whose ovarian cancer recurred had mutations in cfDNA that were previously detected in tumors, said Dr. Arend of the University of Alabama at Birmingham.
Researchers continue to search for ways to spare patients with ovarian cancer from serial biopsies, Dr. Arend noted during a video interview. As part of that work, she and her associates performed longitudinal next-generation sequencing of 50 genes in tumor and plasma specimens from 14 patients with high-grade serous ovarian cancer.
Mutations found only in tumors were relatively consistent before and after neoadjuvant chemotherapy, while mutations found only in cell-free DNA varied substantially.
The researchers also sequenced plasma samples from four patients at cancer recurrence. Three patients had at least one mutation that was previously detected in their tumor sample. Implicated genes included PIK3CA, TP53, KIT, and KDR.
Many studies have sought circulating tumor markers that reliably predict tumor recurrence. When it comes to cfDNA, “we are not there yet,” but the work is worthwhile, Dr. Arend stressed. Sequencing tumor and cfDNA specimens from patients at multiple points during their journey might one day help pinpoint mutations that reliably predict cancer recurrence, sparing patients from repeated biopsies and helping them efficiently enter clinical trials that target their specific mutation, she added.
Dr. Arend cited no funding sources and reported having no conflicts of interest.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
NATIONAL HARBOR, MD. – Next-generation sequencing of high-grade serous ovarian tumor specimens taken during interval debulking identified several mutations that matched those in cell-free DNA (cfDNA), Rebecca C. Arend, MD, said at the annual meeting of the Society of Gynecologic Oncology.
Furthermore, three of four patients whose ovarian cancer recurred had mutations in cfDNA that were previously detected in tumors, said Dr. Arend of the University of Alabama at Birmingham.
Researchers continue to search for ways to spare patients with ovarian cancer from serial biopsies, Dr. Arend noted during a video interview. As part of that work, she and her associates performed longitudinal next-generation sequencing of 50 genes in tumor and plasma specimens from 14 patients with high-grade serous ovarian cancer.
Mutations found only in tumors were relatively consistent before and after neoadjuvant chemotherapy, while mutations found only in cell-free DNA varied substantially.
The researchers also sequenced plasma samples from four patients at cancer recurrence. Three patients had at least one mutation that was previously detected in their tumor sample. Implicated genes included PIK3CA, TP53, KIT, and KDR.
Many studies have sought circulating tumor markers that reliably predict tumor recurrence. When it comes to cfDNA, “we are not there yet,” but the work is worthwhile, Dr. Arend stressed. Sequencing tumor and cfDNA specimens from patients at multiple points during their journey might one day help pinpoint mutations that reliably predict cancer recurrence, sparing patients from repeated biopsies and helping them efficiently enter clinical trials that target their specific mutation, she added.
Dr. Arend cited no funding sources and reported having no conflicts of interest.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT THE ANNUAL MEETING ON WOMEN’S CANCER
Key clinical point: Next-generation sequencing of cell-free DNA specimens (liquid biopsies) might one day help identify tumor recurrence in patients with high-grade serous ovarian cancer.
Major finding: Three of four patients whose cancer recurred had mutations in cell-free DNA that were previously detected in tumor specimens collected during interval debulking.
Data source: Next-generation sequencing of tumor and cell-free (plasma) DNA from 14 patients with high-grade serous ovarian cancer before and after platinum-based neoadjuvant chemotherapy.
Disclosures: Dr. Arend cited no funding sources and reported having no conflicts of interest.
U.S. flu activity continues to decline
The 2016-2017 U.S. influenza season appears to have peaked, as activity measures dropped for the third consecutive week, the Centers for Disease Control and Prevention reported.
For the week ending March 4, there were 11 states at level 10 on the CDC’s 1-10 scale of influenza-like illness (ILI) activity, with another three in the “high” range at levels 8 and 9. The previous week (Feb. 25), there were 22 states at level 10, with a total of 27 in the high range of ILI activity. At the peak of activity during the week of Feb. 11, there were 25 states at level 10, data from the CDC’s Outpatient ILI Surveillance Network show.
There were eight ILI-related pediatric deaths reported during the week ending March 4, although all occurred in earlier weeks. For the 2016-2017 season so far, 48 ILI-related pediatric deaths have been reported, the CDC said.
For the 70 counties in 13 states that report to the Influenza Hospitalization Surveillance Network, the flu-related hospitalization rate for the season is 43.5 per 100,000 population. The highest rate by age group is for those 65 years and over at 198.8 per 100,000, followed by 50- to 64-year-olds at 42.2 per 100,000 and children aged 0-4 years at 28.8 per 100,000, according to the CDC.
The 2016-2017 U.S. influenza season appears to have peaked, as activity measures dropped for the third consecutive week, the Centers for Disease Control and Prevention reported.
For the week ending March 4, there were 11 states at level 10 on the CDC’s 1-10 scale of influenza-like illness (ILI) activity, with another three in the “high” range at levels 8 and 9. The previous week (Feb. 25), there were 22 states at level 10, with a total of 27 in the high range of ILI activity. At the peak of activity during the week of Feb. 11, there were 25 states at level 10, data from the CDC’s Outpatient ILI Surveillance Network show.
There were eight ILI-related pediatric deaths reported during the week ending March 4, although all occurred in earlier weeks. For the 2016-2017 season so far, 48 ILI-related pediatric deaths have been reported, the CDC said.
For the 70 counties in 13 states that report to the Influenza Hospitalization Surveillance Network, the flu-related hospitalization rate for the season is 43.5 per 100,000 population. The highest rate by age group is for those 65 years and over at 198.8 per 100,000, followed by 50- to 64-year-olds at 42.2 per 100,000 and children aged 0-4 years at 28.8 per 100,000, according to the CDC.
The 2016-2017 U.S. influenza season appears to have peaked, as activity measures dropped for the third consecutive week, the Centers for Disease Control and Prevention reported.
For the week ending March 4, there were 11 states at level 10 on the CDC’s 1-10 scale of influenza-like illness (ILI) activity, with another three in the “high” range at levels 8 and 9. The previous week (Feb. 25), there were 22 states at level 10, with a total of 27 in the high range of ILI activity. At the peak of activity during the week of Feb. 11, there were 25 states at level 10, data from the CDC’s Outpatient ILI Surveillance Network show.
There were eight ILI-related pediatric deaths reported during the week ending March 4, although all occurred in earlier weeks. For the 2016-2017 season so far, 48 ILI-related pediatric deaths have been reported, the CDC said.
For the 70 counties in 13 states that report to the Influenza Hospitalization Surveillance Network, the flu-related hospitalization rate for the season is 43.5 per 100,000 population. The highest rate by age group is for those 65 years and over at 198.8 per 100,000, followed by 50- to 64-year-olds at 42.2 per 100,000 and children aged 0-4 years at 28.8 per 100,000, according to the CDC.
No benefit found for routine inpatient rehab after knee replacement
A new randomized study from Australia suggests that for many patients, brief inpatient rehabilitation after knee replacement provides no benefits in several measures, compared with rehab at home.
However, “we are not concluding that there is no role for inpatient rehabilitation after knee arthroplasty,” said study coauthor Justine Naylor, PhD, of the University of New South Wales, Liverpool, Australia. “We are simply saying that for people who are otherwise well enough to be discharged directly home, inpatient rehabilitation does not provide more superior recovery across a range of outcomes.”
For the new study, conducted at two Australian hospitals during 2012-2015, researchers recruited patients aged 40 years or older with a primary diagnosis of osteoarthritis who were undergoing a primary unilateral knee arthroplasty and did not have complications such as a need for inpatient care in recovery beyond an initial 5 days after surgery.
The researchers randomly assigned 165 knee arthroplasty patients with uncomplicated cases to undergo either inpatient rehabilitation for 10 days and then recover at home for 6 weeks or a monitored 6-week home rehab program that began 2 weeks after surgery (JAMA. 2017;317[10]:1037-46).
A third group of 112 patients, 87 of whom were included in the primary analysis, were observed as they entered the home rehab protocol. They were in an initial group of 215 who declined to be randomized, mostly because they wanted to get home quickly after surgery.
The average age of all participants was 67 years, and just over two-thirds were women.
At 26 weeks, the researchers found that there was no significant difference in how the patients in the three groups fared on a 6-minute walk test (mean difference, −1.01 meters; 95% confidence interval, −25.56 to 23.55). They also found no significant difference in measurements of patient-reported pain and function (knee score mean difference, 2.06; 95% CI, −0.59 to 4.71), and quality of life (EQ-5D visual analog scale mean difference, 1.41; 95% CI, −6.42 to 3.60).
However, the patients did seem to have a preference. “Satisfaction with rehabilitation was significantly higher with inpatient rehab, average 92% vs. 83%, though both modes were well received overall,” Dr. Naylor said in an interview.
“Many patients who went to inpatient rehabilitation really enjoyed it,” she added. “We have observed that patients and carers like the convenience of inpatient rehab – a one-stop shop where patients get access to multiple clinicians, gyms, and other patients and do not have to prepare meals.”
However, she said, while “we have no doubt the inpatient rehabilitation environment is nurturing, there must also be advantages to being discharged directly home, otherwise we would have seen differences between the groups. It is possible that monitored home programs like the one provided in this study help people gain independence quickly and empower patients in their recovery.”
Dr. Naylor cautioned that inpatient rehabilitation does have potential benefits for certain patients, such as those who are the most impaired and those without someone available to care for them at home. “Future research could focus on what is best in those situations or, at least, design community-based programs [that] offer some of the perceived benefits of inpatient therapy,” she said. “In addition, we also need to know what the best rehabilitation approach is after hip arthroplasty.”
The study was funded by various sources, including a foundation grant. The study authors reported no relevant disclosures.
A new randomized study from Australia suggests that for many patients, brief inpatient rehabilitation after knee replacement provides no benefits in several measures, compared with rehab at home.
However, “we are not concluding that there is no role for inpatient rehabilitation after knee arthroplasty,” said study coauthor Justine Naylor, PhD, of the University of New South Wales, Liverpool, Australia. “We are simply saying that for people who are otherwise well enough to be discharged directly home, inpatient rehabilitation does not provide more superior recovery across a range of outcomes.”
For the new study, conducted at two Australian hospitals during 2012-2015, researchers recruited patients aged 40 years or older with a primary diagnosis of osteoarthritis who were undergoing a primary unilateral knee arthroplasty and did not have complications such as a need for inpatient care in recovery beyond an initial 5 days after surgery.
The researchers randomly assigned 165 knee arthroplasty patients with uncomplicated cases to undergo either inpatient rehabilitation for 10 days and then recover at home for 6 weeks or a monitored 6-week home rehab program that began 2 weeks after surgery (JAMA. 2017;317[10]:1037-46).
A third group of 112 patients, 87 of whom were included in the primary analysis, were observed as they entered the home rehab protocol. They were in an initial group of 215 who declined to be randomized, mostly because they wanted to get home quickly after surgery.
The average age of all participants was 67 years, and just over two-thirds were women.
At 26 weeks, the researchers found that there was no significant difference in how the patients in the three groups fared on a 6-minute walk test (mean difference, −1.01 meters; 95% confidence interval, −25.56 to 23.55). They also found no significant difference in measurements of patient-reported pain and function (knee score mean difference, 2.06; 95% CI, −0.59 to 4.71), and quality of life (EQ-5D visual analog scale mean difference, 1.41; 95% CI, −6.42 to 3.60).
However, the patients did seem to have a preference. “Satisfaction with rehabilitation was significantly higher with inpatient rehab, average 92% vs. 83%, though both modes were well received overall,” Dr. Naylor said in an interview.
“Many patients who went to inpatient rehabilitation really enjoyed it,” she added. “We have observed that patients and carers like the convenience of inpatient rehab – a one-stop shop where patients get access to multiple clinicians, gyms, and other patients and do not have to prepare meals.”
However, she said, while “we have no doubt the inpatient rehabilitation environment is nurturing, there must also be advantages to being discharged directly home, otherwise we would have seen differences between the groups. It is possible that monitored home programs like the one provided in this study help people gain independence quickly and empower patients in their recovery.”
Dr. Naylor cautioned that inpatient rehabilitation does have potential benefits for certain patients, such as those who are the most impaired and those without someone available to care for them at home. “Future research could focus on what is best in those situations or, at least, design community-based programs [that] offer some of the perceived benefits of inpatient therapy,” she said. “In addition, we also need to know what the best rehabilitation approach is after hip arthroplasty.”
The study was funded by various sources, including a foundation grant. The study authors reported no relevant disclosures.
A new randomized study from Australia suggests that for many patients, brief inpatient rehabilitation after knee replacement provides no benefits in several measures, compared with rehab at home.
However, “we are not concluding that there is no role for inpatient rehabilitation after knee arthroplasty,” said study coauthor Justine Naylor, PhD, of the University of New South Wales, Liverpool, Australia. “We are simply saying that for people who are otherwise well enough to be discharged directly home, inpatient rehabilitation does not provide more superior recovery across a range of outcomes.”
For the new study, conducted at two Australian hospitals during 2012-2015, researchers recruited patients aged 40 years or older with a primary diagnosis of osteoarthritis who were undergoing a primary unilateral knee arthroplasty and did not have complications such as a need for inpatient care in recovery beyond an initial 5 days after surgery.
The researchers randomly assigned 165 knee arthroplasty patients with uncomplicated cases to undergo either inpatient rehabilitation for 10 days and then recover at home for 6 weeks or a monitored 6-week home rehab program that began 2 weeks after surgery (JAMA. 2017;317[10]:1037-46).
A third group of 112 patients, 87 of whom were included in the primary analysis, were observed as they entered the home rehab protocol. They were in an initial group of 215 who declined to be randomized, mostly because they wanted to get home quickly after surgery.
The average age of all participants was 67 years, and just over two-thirds were women.
At 26 weeks, the researchers found that there was no significant difference in how the patients in the three groups fared on a 6-minute walk test (mean difference, −1.01 meters; 95% confidence interval, −25.56 to 23.55). They also found no significant difference in measurements of patient-reported pain and function (knee score mean difference, 2.06; 95% CI, −0.59 to 4.71), and quality of life (EQ-5D visual analog scale mean difference, 1.41; 95% CI, −6.42 to 3.60).
However, the patients did seem to have a preference. “Satisfaction with rehabilitation was significantly higher with inpatient rehab, average 92% vs. 83%, though both modes were well received overall,” Dr. Naylor said in an interview.
“Many patients who went to inpatient rehabilitation really enjoyed it,” she added. “We have observed that patients and carers like the convenience of inpatient rehab – a one-stop shop where patients get access to multiple clinicians, gyms, and other patients and do not have to prepare meals.”
However, she said, while “we have no doubt the inpatient rehabilitation environment is nurturing, there must also be advantages to being discharged directly home, otherwise we would have seen differences between the groups. It is possible that monitored home programs like the one provided in this study help people gain independence quickly and empower patients in their recovery.”
Dr. Naylor cautioned that inpatient rehabilitation does have potential benefits for certain patients, such as those who are the most impaired and those without someone available to care for them at home. “Future research could focus on what is best in those situations or, at least, design community-based programs [that] offer some of the perceived benefits of inpatient therapy,” she said. “In addition, we also need to know what the best rehabilitation approach is after hip arthroplasty.”
The study was funded by various sources, including a foundation grant. The study authors reported no relevant disclosures.
FROM JAMA
Key clinical point:
Major finding: There were no significant differences in the primary outcome of a 6-minute walk test at 26 weeks or in pain, function, and quality of life measures between patients randomized to inpatient or at-home rehab protocols.
Data source: A parallel, randomized controlled trial of 165 uncomplicated knee arthroplasty patients assigned to undergo either inpatient rehab for 10 days then in-home monitored rehab for 6 weeks or to a monitored 6-week home rehab 2 weeks after surgery. The study also included a third observational group of 112 patients (87 included in analysis) who underwent at-home rehab.
Disclosures: The study was funded by various sources, including a foundation grant. The study authors reported no relevant disclosures.
Send children who had anaphylaxis home after 4 hours
ATLANTA – Four hours in the ED are enough to observe most children after anaphylaxis; if they are doing well, they don’t need to be admitted for longer observation, according to Children’s Hospital of Philadelphia investigators.
The right amount of time for observation after anaphylaxis has been debated for years. The current recommendation is 4-8 hours for both children and adults, but it’s a broad range, and some still argue for 24 hours. At least at the Children’s Hospital of Philadelphia (CHOP), much more than 4 hours means that patients need to be admitted to an inpatient floor, or a special extend-care ED unit.
In the fall of 2014, “we decided as a compromise not to go all the way down to 2.5 hours” in the ED, “but to stay within guidelines and go for 4 hours,” so long as kids don’t have asthma or need two epinephrine injections in the ED or have other risks for biphasic reactions, said lead investigator and pediatrician Juhee Lee, MD.
The overall admission rate for pediatric anaphylaxis fell from 58% (106/182) when 8-hour observation was the norm, to 24% (63/257) after ED physicians opted for 4-hour observation in 2014, a near 60% reduction.
Shorter observation was safe; 1% of patients (1/76) came back to the ED within 72 hours before the change, versus 3% (5/194) afterward, a statistically insignificant difference. None of the revisits in either cohort was for severe anaphylaxis symptoms.
“It was surprising to see how significantly we could reduce the admission rate. A 4-hour length of observation appears safe and could drastically improve ED patient flow and decrease hospitalization rates,” Dr. Lee said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
About two-thirds of the ED visits in both groups were for food reactions, most commonly peanut and tree nut allergies.
The CHOP ED also changed how its clinicians treat anaphylaxis over the study period. Children used to get antihistamines and steroids in the ED, and were sent home with 5 days’ worth of both. They also left the ED with a prescription for epinephrine, but not an actual autoinjector.
Now, CHOP lets providers decide if children need antihistamines and steroids in the ED, and sends most home with an EpiPen.
Dr. Lee didn’t have any disclosures. There was no outside funding.
ATLANTA – Four hours in the ED are enough to observe most children after anaphylaxis; if they are doing well, they don’t need to be admitted for longer observation, according to Children’s Hospital of Philadelphia investigators.
The right amount of time for observation after anaphylaxis has been debated for years. The current recommendation is 4-8 hours for both children and adults, but it’s a broad range, and some still argue for 24 hours. At least at the Children’s Hospital of Philadelphia (CHOP), much more than 4 hours means that patients need to be admitted to an inpatient floor, or a special extend-care ED unit.
In the fall of 2014, “we decided as a compromise not to go all the way down to 2.5 hours” in the ED, “but to stay within guidelines and go for 4 hours,” so long as kids don’t have asthma or need two epinephrine injections in the ED or have other risks for biphasic reactions, said lead investigator and pediatrician Juhee Lee, MD.
The overall admission rate for pediatric anaphylaxis fell from 58% (106/182) when 8-hour observation was the norm, to 24% (63/257) after ED physicians opted for 4-hour observation in 2014, a near 60% reduction.
Shorter observation was safe; 1% of patients (1/76) came back to the ED within 72 hours before the change, versus 3% (5/194) afterward, a statistically insignificant difference. None of the revisits in either cohort was for severe anaphylaxis symptoms.
“It was surprising to see how significantly we could reduce the admission rate. A 4-hour length of observation appears safe and could drastically improve ED patient flow and decrease hospitalization rates,” Dr. Lee said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
About two-thirds of the ED visits in both groups were for food reactions, most commonly peanut and tree nut allergies.
The CHOP ED also changed how its clinicians treat anaphylaxis over the study period. Children used to get antihistamines and steroids in the ED, and were sent home with 5 days’ worth of both. They also left the ED with a prescription for epinephrine, but not an actual autoinjector.
Now, CHOP lets providers decide if children need antihistamines and steroids in the ED, and sends most home with an EpiPen.
Dr. Lee didn’t have any disclosures. There was no outside funding.
ATLANTA – Four hours in the ED are enough to observe most children after anaphylaxis; if they are doing well, they don’t need to be admitted for longer observation, according to Children’s Hospital of Philadelphia investigators.
The right amount of time for observation after anaphylaxis has been debated for years. The current recommendation is 4-8 hours for both children and adults, but it’s a broad range, and some still argue for 24 hours. At least at the Children’s Hospital of Philadelphia (CHOP), much more than 4 hours means that patients need to be admitted to an inpatient floor, or a special extend-care ED unit.
In the fall of 2014, “we decided as a compromise not to go all the way down to 2.5 hours” in the ED, “but to stay within guidelines and go for 4 hours,” so long as kids don’t have asthma or need two epinephrine injections in the ED or have other risks for biphasic reactions, said lead investigator and pediatrician Juhee Lee, MD.
The overall admission rate for pediatric anaphylaxis fell from 58% (106/182) when 8-hour observation was the norm, to 24% (63/257) after ED physicians opted for 4-hour observation in 2014, a near 60% reduction.
Shorter observation was safe; 1% of patients (1/76) came back to the ED within 72 hours before the change, versus 3% (5/194) afterward, a statistically insignificant difference. None of the revisits in either cohort was for severe anaphylaxis symptoms.
“It was surprising to see how significantly we could reduce the admission rate. A 4-hour length of observation appears safe and could drastically improve ED patient flow and decrease hospitalization rates,” Dr. Lee said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
About two-thirds of the ED visits in both groups were for food reactions, most commonly peanut and tree nut allergies.
The CHOP ED also changed how its clinicians treat anaphylaxis over the study period. Children used to get antihistamines and steroids in the ED, and were sent home with 5 days’ worth of both. They also left the ED with a prescription for epinephrine, but not an actual autoinjector.
Now, CHOP lets providers decide if children need antihistamines and steroids in the ED, and sends most home with an EpiPen.
Dr. Lee didn’t have any disclosures. There was no outside funding.
Key clinical point:
Major finding: The overall admission rate for pediatric anaphylaxis fell from 58% (106/182) when 8-hour observation was the norm, to 24% (63/257) after ED doctors opted for 4-hour observation in 2014, a near 60% reduction.
Data source: A study of 182 children who underwent 8-hour observation and 257 children who underwent 4-hour observation at the Children’s Hospital of Philadelphia ED.
Disclosures: The lead investigator didn’t have any disclosures. There was no outside funding.
Universal preterm birth screening not ready for prime time
Two screens to predict spontaneous preterm birth in low-risk women, which were rapidly adapted into clinical practice despite a lack of supportive evidence, proved to have little predictive value in a large cohort study.
Transvaginal ultrasound examination for short cervical length and quantitative cervicovaginal swabbing for fetal fibronectin are routinely used to predict spontaneous preterm birth. To assess the accuracy of both screens individually and in combination, researchers analyzed data for women participating in the prospective multicenter Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be (nuMoM2b). They focused on 9,410 nulliparous women with singleton pregnancies who were followed at eight clinical centers across the country. In addition to regular pregnancy visits, these women underwent both screening procedures at approximately 12 weeks, 19 weeks, and 28 weeks.
Both screens had relatively low sensitivity and low positive predictive value, regardless of when they were performed, which threshold values were used, and whether the results were considered individually or in combination (JAMA. 2017;317[10]:1047-56).
Transvaginal cervical length at 22-30 weeks’ gestation was the most accurate predictor of spontaneous preterm birth before 37 weeks, outperforming fetal fibronectin assessment alone. However, with a threshold of 25 mm or less – the most commonly used clinical cutoff – cervical length screening identified just 23.3% of spontaneous preterm births before 37 weeks. Use of that same threshold at 16-22 weeks – the most common time for screening in clinical practice – identified just 8% of subsequent spontaneous preterm births. The addition of fetal fibronectin did not increase the predictive performance of cervical length alone, according to the findings.
The researchers cited the low incidence of short cervix (1% at 16-22 weeks) as a potential reason why the ultrasound screen was not useful. “Using the most conservative threshold of 25 mm or less in the most common time for clinical screening (16-22 weeks’ gestation), 247 women would need to be screened to identify 1 case of spontaneous preterm birth,” the researchers wrote. Using a transvaginal cervical length of 15 mm or less during the same time period, the number needed to screen rose to 680 to identify a single case of spontaneous preterm birth.
These findings do not support the routine use of these two screens among nulliparous women with singleton pregnancies, the researchers wrote. Screening procedures with relatively poor predictive values “may sometimes be useful if they are inexpensive, lack serious adverse effects, and address a serious condition for which an effective intervention exists. Neither of these tests, alone or in combination, meets all of these criteria,” they added.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development supported the study. Dr. Esplin reported holding a patent for serum markers of preterm birth and ties to Sera Prognostics and Clinical Innovations. One of his coauthors reported ties to Natera, Sequenom, Illumina, March of Dimes, Ariosa Diagnostics/Roche, KellBenx, and LabCorp.
The report by Esplin and colleagues is important for at least two reasons. First, this large and well-executed prospective study provides compelling data that two popular screening modalities, either alone or in combination, do not accurately predict which women will deliver preterm. Second, this report provides provocative insights as to how medical practice determined through consensus, rather than reproducible evidence, contributes to the narrative in the United States regarding the cost and quality of health care.
In 2012, the publications committee of the Society for Maternal-Fetal Medicine provided a consensus clinical guideline for use of progesterone for the prevention of preterm birth. The guideline indicated that vaginal progesterone was beneficial for women at low risk for preterm birth who were discovered to have short cervical length during an ultrasound examination. This recommendation raised the issue of universal testing for short cervix in women such as those screened in the study by Esplin and colleagues. The authors of the clinical guideline, which was reaffirmed in 2016, stated that “cervical length screening in singleton gestations without prior preterm birth cannot yet be universally mandated. Nonetheless, implementation of such a screening strategy can be viewed as reasonable, and can be considered by individual practitioners.” Similarly, one of the recommendations – although based on limited or inconsistent scientific evidence – promulgated by the American College of Obstetricians and Gynecologists in its 2012 Practice Bulletin on Prediction and Prevention of Preterm Birth, and also reaffirmed in 2016, stated that “although this document does not mandate universal cervical length screening in women without a prior preterm birth, this screening strategy may be considered.”
The important study by Esplin and colleagues should serve to temper the use of two controversial screening approaches. While it is gratifying that such research takes place, that research should have preceded the adoption of this screening strategy into practice.
Steven L. Bloom, MD, and Kenneth J. Leveno, MD, are in the department of ob.gyn. at the University of Texas Southwestern Medical Center, Dallas. They reported having no relevant financial disclosures. These comments are excerpted from an editorial ( JAMA. 2017;317[10]:1025-26).
The report by Esplin and colleagues is important for at least two reasons. First, this large and well-executed prospective study provides compelling data that two popular screening modalities, either alone or in combination, do not accurately predict which women will deliver preterm. Second, this report provides provocative insights as to how medical practice determined through consensus, rather than reproducible evidence, contributes to the narrative in the United States regarding the cost and quality of health care.
In 2012, the publications committee of the Society for Maternal-Fetal Medicine provided a consensus clinical guideline for use of progesterone for the prevention of preterm birth. The guideline indicated that vaginal progesterone was beneficial for women at low risk for preterm birth who were discovered to have short cervical length during an ultrasound examination. This recommendation raised the issue of universal testing for short cervix in women such as those screened in the study by Esplin and colleagues. The authors of the clinical guideline, which was reaffirmed in 2016, stated that “cervical length screening in singleton gestations without prior preterm birth cannot yet be universally mandated. Nonetheless, implementation of such a screening strategy can be viewed as reasonable, and can be considered by individual practitioners.” Similarly, one of the recommendations – although based on limited or inconsistent scientific evidence – promulgated by the American College of Obstetricians and Gynecologists in its 2012 Practice Bulletin on Prediction and Prevention of Preterm Birth, and also reaffirmed in 2016, stated that “although this document does not mandate universal cervical length screening in women without a prior preterm birth, this screening strategy may be considered.”
The important study by Esplin and colleagues should serve to temper the use of two controversial screening approaches. While it is gratifying that such research takes place, that research should have preceded the adoption of this screening strategy into practice.
Steven L. Bloom, MD, and Kenneth J. Leveno, MD, are in the department of ob.gyn. at the University of Texas Southwestern Medical Center, Dallas. They reported having no relevant financial disclosures. These comments are excerpted from an editorial ( JAMA. 2017;317[10]:1025-26).
The report by Esplin and colleagues is important for at least two reasons. First, this large and well-executed prospective study provides compelling data that two popular screening modalities, either alone or in combination, do not accurately predict which women will deliver preterm. Second, this report provides provocative insights as to how medical practice determined through consensus, rather than reproducible evidence, contributes to the narrative in the United States regarding the cost and quality of health care.
In 2012, the publications committee of the Society for Maternal-Fetal Medicine provided a consensus clinical guideline for use of progesterone for the prevention of preterm birth. The guideline indicated that vaginal progesterone was beneficial for women at low risk for preterm birth who were discovered to have short cervical length during an ultrasound examination. This recommendation raised the issue of universal testing for short cervix in women such as those screened in the study by Esplin and colleagues. The authors of the clinical guideline, which was reaffirmed in 2016, stated that “cervical length screening in singleton gestations without prior preterm birth cannot yet be universally mandated. Nonetheless, implementation of such a screening strategy can be viewed as reasonable, and can be considered by individual practitioners.” Similarly, one of the recommendations – although based on limited or inconsistent scientific evidence – promulgated by the American College of Obstetricians and Gynecologists in its 2012 Practice Bulletin on Prediction and Prevention of Preterm Birth, and also reaffirmed in 2016, stated that “although this document does not mandate universal cervical length screening in women without a prior preterm birth, this screening strategy may be considered.”
The important study by Esplin and colleagues should serve to temper the use of two controversial screening approaches. While it is gratifying that such research takes place, that research should have preceded the adoption of this screening strategy into practice.
Steven L. Bloom, MD, and Kenneth J. Leveno, MD, are in the department of ob.gyn. at the University of Texas Southwestern Medical Center, Dallas. They reported having no relevant financial disclosures. These comments are excerpted from an editorial ( JAMA. 2017;317[10]:1025-26).
Two screens to predict spontaneous preterm birth in low-risk women, which were rapidly adapted into clinical practice despite a lack of supportive evidence, proved to have little predictive value in a large cohort study.
Transvaginal ultrasound examination for short cervical length and quantitative cervicovaginal swabbing for fetal fibronectin are routinely used to predict spontaneous preterm birth. To assess the accuracy of both screens individually and in combination, researchers analyzed data for women participating in the prospective multicenter Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be (nuMoM2b). They focused on 9,410 nulliparous women with singleton pregnancies who were followed at eight clinical centers across the country. In addition to regular pregnancy visits, these women underwent both screening procedures at approximately 12 weeks, 19 weeks, and 28 weeks.
Both screens had relatively low sensitivity and low positive predictive value, regardless of when they were performed, which threshold values were used, and whether the results were considered individually or in combination (JAMA. 2017;317[10]:1047-56).
Transvaginal cervical length at 22-30 weeks’ gestation was the most accurate predictor of spontaneous preterm birth before 37 weeks, outperforming fetal fibronectin assessment alone. However, with a threshold of 25 mm or less – the most commonly used clinical cutoff – cervical length screening identified just 23.3% of spontaneous preterm births before 37 weeks. Use of that same threshold at 16-22 weeks – the most common time for screening in clinical practice – identified just 8% of subsequent spontaneous preterm births. The addition of fetal fibronectin did not increase the predictive performance of cervical length alone, according to the findings.
The researchers cited the low incidence of short cervix (1% at 16-22 weeks) as a potential reason why the ultrasound screen was not useful. “Using the most conservative threshold of 25 mm or less in the most common time for clinical screening (16-22 weeks’ gestation), 247 women would need to be screened to identify 1 case of spontaneous preterm birth,” the researchers wrote. Using a transvaginal cervical length of 15 mm or less during the same time period, the number needed to screen rose to 680 to identify a single case of spontaneous preterm birth.
These findings do not support the routine use of these two screens among nulliparous women with singleton pregnancies, the researchers wrote. Screening procedures with relatively poor predictive values “may sometimes be useful if they are inexpensive, lack serious adverse effects, and address a serious condition for which an effective intervention exists. Neither of these tests, alone or in combination, meets all of these criteria,” they added.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development supported the study. Dr. Esplin reported holding a patent for serum markers of preterm birth and ties to Sera Prognostics and Clinical Innovations. One of his coauthors reported ties to Natera, Sequenom, Illumina, March of Dimes, Ariosa Diagnostics/Roche, KellBenx, and LabCorp.
Two screens to predict spontaneous preterm birth in low-risk women, which were rapidly adapted into clinical practice despite a lack of supportive evidence, proved to have little predictive value in a large cohort study.
Transvaginal ultrasound examination for short cervical length and quantitative cervicovaginal swabbing for fetal fibronectin are routinely used to predict spontaneous preterm birth. To assess the accuracy of both screens individually and in combination, researchers analyzed data for women participating in the prospective multicenter Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be (nuMoM2b). They focused on 9,410 nulliparous women with singleton pregnancies who were followed at eight clinical centers across the country. In addition to regular pregnancy visits, these women underwent both screening procedures at approximately 12 weeks, 19 weeks, and 28 weeks.
Both screens had relatively low sensitivity and low positive predictive value, regardless of when they were performed, which threshold values were used, and whether the results were considered individually or in combination (JAMA. 2017;317[10]:1047-56).
Transvaginal cervical length at 22-30 weeks’ gestation was the most accurate predictor of spontaneous preterm birth before 37 weeks, outperforming fetal fibronectin assessment alone. However, with a threshold of 25 mm or less – the most commonly used clinical cutoff – cervical length screening identified just 23.3% of spontaneous preterm births before 37 weeks. Use of that same threshold at 16-22 weeks – the most common time for screening in clinical practice – identified just 8% of subsequent spontaneous preterm births. The addition of fetal fibronectin did not increase the predictive performance of cervical length alone, according to the findings.
The researchers cited the low incidence of short cervix (1% at 16-22 weeks) as a potential reason why the ultrasound screen was not useful. “Using the most conservative threshold of 25 mm or less in the most common time for clinical screening (16-22 weeks’ gestation), 247 women would need to be screened to identify 1 case of spontaneous preterm birth,” the researchers wrote. Using a transvaginal cervical length of 15 mm or less during the same time period, the number needed to screen rose to 680 to identify a single case of spontaneous preterm birth.
These findings do not support the routine use of these two screens among nulliparous women with singleton pregnancies, the researchers wrote. Screening procedures with relatively poor predictive values “may sometimes be useful if they are inexpensive, lack serious adverse effects, and address a serious condition for which an effective intervention exists. Neither of these tests, alone or in combination, meets all of these criteria,” they added.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development supported the study. Dr. Esplin reported holding a patent for serum markers of preterm birth and ties to Sera Prognostics and Clinical Innovations. One of his coauthors reported ties to Natera, Sequenom, Illumina, March of Dimes, Ariosa Diagnostics/Roche, KellBenx, and LabCorp.
FROM JAMA
Key clinical point:
Major finding: With a threshold of transvaginal cervical length of 25 mm or less at 16-22 weeks’ gestation, 247 women would need to be screened to identify one case of spontaneous preterm birth before 37 weeks’ gestation.
Data source: A prospective multicenter observational cohort study involving 9,410 nulliparous women across the United States.
Disclosures: The Eunice Kennedy Shriver National Institute of Child Health and Human Development supported the study. Dr. Esplin reported holding a patent for serum markers of preterm birth and ties to Sera Prognostics and Clinical Innovations. An associate reported ties to Natera, Sequenom, Illumina, March of Dimes, Ariosa Diagnostics/Roche, KellBenx, and LabCorp.