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“No consequence” Knowledge Check-In expands
In 2018, ABIM is introducing the new Knowledge Check-In assessment option, an every-2-year assessment option serving as an alternative to the 10-year assessment model. Initially, for 2018, this option will be piloted for both Internal Medicine and Nephrology. In 2019, the Knowledge Check-In will expand to several additional specialties, including Pulmonary Disease. The remaining specialties, including Critical Care Medicine, will become available in 2020.
Previously, ABIM announced that physicians taking the Knowledge Check-In in 2018—the initial year it is offered in Internal Medicine or Nephrology—would have another chance to take it again 2 years later if they were unsuccessful, even if they were due to pass the exam that year. Based on feedback ABIM received from the physician community, this feature is now being extended to include all other Internal Medicine subspecialties in the future. Therefore, if a physician opts to take the Knowledge Check-In the first year it is offered in their subspecialty and is unsuccessful, they will get at least one additional opportunity to take it 2 years later.
For more information visit www.abim.org/checkin.
In 2018, ABIM is introducing the new Knowledge Check-In assessment option, an every-2-year assessment option serving as an alternative to the 10-year assessment model. Initially, for 2018, this option will be piloted for both Internal Medicine and Nephrology. In 2019, the Knowledge Check-In will expand to several additional specialties, including Pulmonary Disease. The remaining specialties, including Critical Care Medicine, will become available in 2020.
Previously, ABIM announced that physicians taking the Knowledge Check-In in 2018—the initial year it is offered in Internal Medicine or Nephrology—would have another chance to take it again 2 years later if they were unsuccessful, even if they were due to pass the exam that year. Based on feedback ABIM received from the physician community, this feature is now being extended to include all other Internal Medicine subspecialties in the future. Therefore, if a physician opts to take the Knowledge Check-In the first year it is offered in their subspecialty and is unsuccessful, they will get at least one additional opportunity to take it 2 years later.
For more information visit www.abim.org/checkin.
In 2018, ABIM is introducing the new Knowledge Check-In assessment option, an every-2-year assessment option serving as an alternative to the 10-year assessment model. Initially, for 2018, this option will be piloted for both Internal Medicine and Nephrology. In 2019, the Knowledge Check-In will expand to several additional specialties, including Pulmonary Disease. The remaining specialties, including Critical Care Medicine, will become available in 2020.
Previously, ABIM announced that physicians taking the Knowledge Check-In in 2018—the initial year it is offered in Internal Medicine or Nephrology—would have another chance to take it again 2 years later if they were unsuccessful, even if they were due to pass the exam that year. Based on feedback ABIM received from the physician community, this feature is now being extended to include all other Internal Medicine subspecialties in the future. Therefore, if a physician opts to take the Knowledge Check-In the first year it is offered in their subspecialty and is unsuccessful, they will get at least one additional opportunity to take it 2 years later.
For more information visit www.abim.org/checkin.
New strategic plan for CHEST
We are pleased to announce the completion of a new, multiyear strategic plan for CHEST. Over the past few years, key stakeholders have provided essential input, resulting in a plan that identifies a very focused set of priorities we’ll pursue to help achieve our overarching strategy. Having selected these priorities, which leverage our strengths and strategic advantages, we are committed to dedicating sufficient resources toward their accomplishment over the next several years.
Each year, the plan will be reviewed and modified to reflect changes to CHEST priorities.
A strategic plan is an important tool for our organization because it truly does focus and direct our efforts and resources. Guided by our 2013-2017 strategic plan, we were able to accomplish the following:
- Developed events, products, and services that produced meaningful education for the CHEST community and generated positive financial margins;
- Optimized our membership model to increase engagement of all clinicians on the health-care team;
- Enhanced our global presence through guideline development and increased educational offerings;
- Launched a new Association Management System (AMS) and made strides to becoming a data-driven organization;
- Built and moved into a new building that enhanced our ability to develop and host courses in the CHEST Innovation, Simulation, and Training Center;
- Increased our visibility through our rebrand as “CHEST”;
- Fostered relationships and collaborated with other organizations to promote lung health through the CHEST Foundation; and
- Met our budget goals and financial covenants with our bank, and increased the CHEST Foundation’s corpus for grants and awards.
This new strategic plan can be found on chestnet.org under the “About” section. As members of CHEST, we invite you to review what’s outlined and become familiar with what the plan encompasses. This plan provides details to help you understand the future direction of CHEST, and we know you’ll support us in these important endeavors.
We are pleased to announce the completion of a new, multiyear strategic plan for CHEST. Over the past few years, key stakeholders have provided essential input, resulting in a plan that identifies a very focused set of priorities we’ll pursue to help achieve our overarching strategy. Having selected these priorities, which leverage our strengths and strategic advantages, we are committed to dedicating sufficient resources toward their accomplishment over the next several years.
Each year, the plan will be reviewed and modified to reflect changes to CHEST priorities.
A strategic plan is an important tool for our organization because it truly does focus and direct our efforts and resources. Guided by our 2013-2017 strategic plan, we were able to accomplish the following:
- Developed events, products, and services that produced meaningful education for the CHEST community and generated positive financial margins;
- Optimized our membership model to increase engagement of all clinicians on the health-care team;
- Enhanced our global presence through guideline development and increased educational offerings;
- Launched a new Association Management System (AMS) and made strides to becoming a data-driven organization;
- Built and moved into a new building that enhanced our ability to develop and host courses in the CHEST Innovation, Simulation, and Training Center;
- Increased our visibility through our rebrand as “CHEST”;
- Fostered relationships and collaborated with other organizations to promote lung health through the CHEST Foundation; and
- Met our budget goals and financial covenants with our bank, and increased the CHEST Foundation’s corpus for grants and awards.
This new strategic plan can be found on chestnet.org under the “About” section. As members of CHEST, we invite you to review what’s outlined and become familiar with what the plan encompasses. This plan provides details to help you understand the future direction of CHEST, and we know you’ll support us in these important endeavors.
We are pleased to announce the completion of a new, multiyear strategic plan for CHEST. Over the past few years, key stakeholders have provided essential input, resulting in a plan that identifies a very focused set of priorities we’ll pursue to help achieve our overarching strategy. Having selected these priorities, which leverage our strengths and strategic advantages, we are committed to dedicating sufficient resources toward their accomplishment over the next several years.
Each year, the plan will be reviewed and modified to reflect changes to CHEST priorities.
A strategic plan is an important tool for our organization because it truly does focus and direct our efforts and resources. Guided by our 2013-2017 strategic plan, we were able to accomplish the following:
- Developed events, products, and services that produced meaningful education for the CHEST community and generated positive financial margins;
- Optimized our membership model to increase engagement of all clinicians on the health-care team;
- Enhanced our global presence through guideline development and increased educational offerings;
- Launched a new Association Management System (AMS) and made strides to becoming a data-driven organization;
- Built and moved into a new building that enhanced our ability to develop and host courses in the CHEST Innovation, Simulation, and Training Center;
- Increased our visibility through our rebrand as “CHEST”;
- Fostered relationships and collaborated with other organizations to promote lung health through the CHEST Foundation; and
- Met our budget goals and financial covenants with our bank, and increased the CHEST Foundation’s corpus for grants and awards.
This new strategic plan can be found on chestnet.org under the “About” section. As members of CHEST, we invite you to review what’s outlined and become familiar with what the plan encompasses. This plan provides details to help you understand the future direction of CHEST, and we know you’ll support us in these important endeavors.
Study: Preop EKGs have little utility for benign hysterectomy
ORLANDO – Preoperative electrocardiograms (EKGs) had no effect on management or perioperative complications in women undergoing benign hysterectomy over a 12-month period at a single medical center, according to a review of records.
Of 587 patients included in the review, 182 (31%) underwent EKG as part of their preoperative evaluation, and the majority of those were indicated according to institutional criteria (166; 28%) or National Institute for Health Care Excellence (NICE) guidelines (177; 30%), Nemi M. Shah, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
“EKG was indicated in 91% of these patients according to institutional criteria, and in 97% of patients per NICE criteria,” said Dr. Shah, a third-year resident at the University of Texas Southwestern Medical Center, Dallas.
By institutional criteria, hypertension was the most common indication (68% of cases), and by NICE criteria, American Society of Anesthesia class 2 physical status was the most common indication (80% of cases), she noted, adding that obesity, which was present in 70% of patients, was the most common comorbidity classifying patients with American Society of Anesthesia class 2 or above.
Of the 182 EKGs performed, findings were abnormal in 89, but further workup was pursued in only 16 patients, and included repeat EKG, echocardiogram, and/or stress testing and cardiology consultation. Surgical delays of 1 and 4 months occurred in 2 patients as a result of the additional workup, and ultimately, all planned hysterectomies were completed by the primary surgical team without changes in management, she said.
Perioperative complications occurred in two patients, and included nonspecific postinduction EKG changes that led to surgery being aborted in one patient who had left ventricular hypertrophy on the preoperative EKG, and failed extubation in a patient with airway edema whose preoperative EKG showed a nonacute inferior infarct.
For the first, cardiology was consulted and determined the findings to be benign; the patient underwent hysterectomy at a later date without complications. The second patient was taken to the surgical intensive care unit for management, Dr. Shah said.
“Preoperative testing for benign hysterectomy is variable as there is no single standard of care,” she explained. “Though tests such as EKG are commonly ordered, there are no data linking study results to surgical outcomes.”
The current study was conducted to evaluate the rate of preoperative EKG performed in concordance with institutional and NICE guidelines, and to assess implications for management and perioperative complications.
Patients included in the review were adult women who underwent scheduled benign hysterectomy during 2016. Women who underwent emergency surgery or whose surgery was performed by gynecologic oncologists were excluded.
Subjects were primarily Hispanic, and had a mean age of 45 years, Dr. Shah noted.
Though limited by the single-center design and retrospective nature of the study, the findings suggest that preoperative EKG has little clinical utility.
“We found that practice patterns were highly concordant with institutional and NICE guidelines. However, EKG resulted in minimal impact on perioperative management, and no association between abnormal EKG and perioperative complications was found,” she said. “EKG may not accurately stratify perioperative cardiopulmonary risk, and alternative methods for preoperative evaluation should be considered.”
Dr. Shah reported having no disclosures.
SOURCE: Shah N et al. SGS 2018 Oral Poster 3.
ORLANDO – Preoperative electrocardiograms (EKGs) had no effect on management or perioperative complications in women undergoing benign hysterectomy over a 12-month period at a single medical center, according to a review of records.
Of 587 patients included in the review, 182 (31%) underwent EKG as part of their preoperative evaluation, and the majority of those were indicated according to institutional criteria (166; 28%) or National Institute for Health Care Excellence (NICE) guidelines (177; 30%), Nemi M. Shah, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
“EKG was indicated in 91% of these patients according to institutional criteria, and in 97% of patients per NICE criteria,” said Dr. Shah, a third-year resident at the University of Texas Southwestern Medical Center, Dallas.
By institutional criteria, hypertension was the most common indication (68% of cases), and by NICE criteria, American Society of Anesthesia class 2 physical status was the most common indication (80% of cases), she noted, adding that obesity, which was present in 70% of patients, was the most common comorbidity classifying patients with American Society of Anesthesia class 2 or above.
Of the 182 EKGs performed, findings were abnormal in 89, but further workup was pursued in only 16 patients, and included repeat EKG, echocardiogram, and/or stress testing and cardiology consultation. Surgical delays of 1 and 4 months occurred in 2 patients as a result of the additional workup, and ultimately, all planned hysterectomies were completed by the primary surgical team without changes in management, she said.
Perioperative complications occurred in two patients, and included nonspecific postinduction EKG changes that led to surgery being aborted in one patient who had left ventricular hypertrophy on the preoperative EKG, and failed extubation in a patient with airway edema whose preoperative EKG showed a nonacute inferior infarct.
For the first, cardiology was consulted and determined the findings to be benign; the patient underwent hysterectomy at a later date without complications. The second patient was taken to the surgical intensive care unit for management, Dr. Shah said.
“Preoperative testing for benign hysterectomy is variable as there is no single standard of care,” she explained. “Though tests such as EKG are commonly ordered, there are no data linking study results to surgical outcomes.”
The current study was conducted to evaluate the rate of preoperative EKG performed in concordance with institutional and NICE guidelines, and to assess implications for management and perioperative complications.
Patients included in the review were adult women who underwent scheduled benign hysterectomy during 2016. Women who underwent emergency surgery or whose surgery was performed by gynecologic oncologists were excluded.
Subjects were primarily Hispanic, and had a mean age of 45 years, Dr. Shah noted.
Though limited by the single-center design and retrospective nature of the study, the findings suggest that preoperative EKG has little clinical utility.
“We found that practice patterns were highly concordant with institutional and NICE guidelines. However, EKG resulted in minimal impact on perioperative management, and no association between abnormal EKG and perioperative complications was found,” she said. “EKG may not accurately stratify perioperative cardiopulmonary risk, and alternative methods for preoperative evaluation should be considered.”
Dr. Shah reported having no disclosures.
SOURCE: Shah N et al. SGS 2018 Oral Poster 3.
ORLANDO – Preoperative electrocardiograms (EKGs) had no effect on management or perioperative complications in women undergoing benign hysterectomy over a 12-month period at a single medical center, according to a review of records.
Of 587 patients included in the review, 182 (31%) underwent EKG as part of their preoperative evaluation, and the majority of those were indicated according to institutional criteria (166; 28%) or National Institute for Health Care Excellence (NICE) guidelines (177; 30%), Nemi M. Shah, MD, reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
“EKG was indicated in 91% of these patients according to institutional criteria, and in 97% of patients per NICE criteria,” said Dr. Shah, a third-year resident at the University of Texas Southwestern Medical Center, Dallas.
By institutional criteria, hypertension was the most common indication (68% of cases), and by NICE criteria, American Society of Anesthesia class 2 physical status was the most common indication (80% of cases), she noted, adding that obesity, which was present in 70% of patients, was the most common comorbidity classifying patients with American Society of Anesthesia class 2 or above.
Of the 182 EKGs performed, findings were abnormal in 89, but further workup was pursued in only 16 patients, and included repeat EKG, echocardiogram, and/or stress testing and cardiology consultation. Surgical delays of 1 and 4 months occurred in 2 patients as a result of the additional workup, and ultimately, all planned hysterectomies were completed by the primary surgical team without changes in management, she said.
Perioperative complications occurred in two patients, and included nonspecific postinduction EKG changes that led to surgery being aborted in one patient who had left ventricular hypertrophy on the preoperative EKG, and failed extubation in a patient with airway edema whose preoperative EKG showed a nonacute inferior infarct.
For the first, cardiology was consulted and determined the findings to be benign; the patient underwent hysterectomy at a later date without complications. The second patient was taken to the surgical intensive care unit for management, Dr. Shah said.
“Preoperative testing for benign hysterectomy is variable as there is no single standard of care,” she explained. “Though tests such as EKG are commonly ordered, there are no data linking study results to surgical outcomes.”
The current study was conducted to evaluate the rate of preoperative EKG performed in concordance with institutional and NICE guidelines, and to assess implications for management and perioperative complications.
Patients included in the review were adult women who underwent scheduled benign hysterectomy during 2016. Women who underwent emergency surgery or whose surgery was performed by gynecologic oncologists were excluded.
Subjects were primarily Hispanic, and had a mean age of 45 years, Dr. Shah noted.
Though limited by the single-center design and retrospective nature of the study, the findings suggest that preoperative EKG has little clinical utility.
“We found that practice patterns were highly concordant with institutional and NICE guidelines. However, EKG resulted in minimal impact on perioperative management, and no association between abnormal EKG and perioperative complications was found,” she said. “EKG may not accurately stratify perioperative cardiopulmonary risk, and alternative methods for preoperative evaluation should be considered.”
Dr. Shah reported having no disclosures.
SOURCE: Shah N et al. SGS 2018 Oral Poster 3.
REPORTING FROM SGS 2018
Key clinical point: Preoperative EKG appears to have little utility in patients undergoing benign hysterectomy.
Major finding: Only 16 of 89 patients with abnormal preoperative EKG underwent further workup, and surgery was delayed in only two cases.
Study details: A retrospective review of 587 cases.
Disclosures: Dr. Shah reported having no disclosures.
Source: Shah N et al. SGS 2018 Oral Poster 3.
Trastuzumab plus chemo shows efficacy for high HER2 endometrial cancer
NEW ORLEANS – Adding the anti-HER2 antibody trastuzumab to a standard chemotherapy regimen produced markedly improved responses among patients with an advanced stage or recurrent uterine serous carcinoma that also overexpressed the HER2/neu cell receptor protein in a controlled, multicenter, phase 2 study with 58 evaluable patients.
The 30 patients who received trastuzumab along with carboplatin plus paclitaxel had a median progression-free survival of 12.6 months compared with 8.0 months among the 28 control patients who received only carboplatin plus paclitaxel, a hazard reduction of 56% with trastuzumab that was statistically significant (P = .0052), Alessandro D. Santin, MD, said at the annual meeting of the Society of Gynecologic Oncology.
In the subgroup of 41 patients with advanced (not recurrent) uterine serous carcinoma (USC) the incremental difference in median progression-free survival among patients treated with trastuzumab was 8.6 months, based on a 17.9-month duration in the 20 patients who received trastuzumab and 9.3 months in 20 control patients on chemotherapy only (P = .013).
“We’ll push to have the trastuzumab, carboplatin, and paclitaxel regimen in the guidelines” for treating patients with USC that overexpresses HER2/neu, agreed Amanda N. Fader, MD, director of gynecologic oncology at Johns Hopkins Medicine in Baltimore and lead author on the study reported by Dr. Santin.
Shortly after Dr. Santin’s report at the meeting, the results appeared in an article published online March 27 in Journal of Clinical Oncology.
The phase 2 trial ran at 11 U.S. centers during 2011-2016, and randomized 61 patients with stage III or IV or recurrent USC and high HER2 protein expression measured by immunohistochemistry and amplification of the HER2 gene shown by fluorescence in situ hybridization. The researchers collected data from 58 treated patients. Among the 17 patients with recurrent disease, those who received trastuzumab had a median progression-free survival of 9.2 months compared with 6.0 months in the controls, a hazard reduction of 86% with trastuzumab that was statistically significant (P = .0029). The addition of trastuzumab to carboplatin and paclitaxel was well tolerated.
The greatest benefit from the trastuzumab plus chemotherapy regimen might occur when used as first-line treatment, Dr. Santin suggested. He expressed interest in running a second study to validate the current findings, and a new study that would combine a second antibody directed against HER2, pertuzumab (Perjeta) with trastuzumab, carboplatin, and paclitaxel.
A key factor in making the trastuzumab plus chemotherapy regimen more widely available to USC patients would be routinely screening these patients for high levels of HER2/neu expression immediately after USC is diagnosed. “At Yale and Johns Hopkins this testing is done on all USC patients. That’s not standard care everywhere, but it should be based on these data,” Dr. Santin said in an interview.
SOURCE: Fader A et al. Abstract 22. J Clin Oncol. 2018 Mar 27. doi: 10.1200/JCO.2017.76.5966.
NEW ORLEANS – Adding the anti-HER2 antibody trastuzumab to a standard chemotherapy regimen produced markedly improved responses among patients with an advanced stage or recurrent uterine serous carcinoma that also overexpressed the HER2/neu cell receptor protein in a controlled, multicenter, phase 2 study with 58 evaluable patients.
The 30 patients who received trastuzumab along with carboplatin plus paclitaxel had a median progression-free survival of 12.6 months compared with 8.0 months among the 28 control patients who received only carboplatin plus paclitaxel, a hazard reduction of 56% with trastuzumab that was statistically significant (P = .0052), Alessandro D. Santin, MD, said at the annual meeting of the Society of Gynecologic Oncology.
In the subgroup of 41 patients with advanced (not recurrent) uterine serous carcinoma (USC) the incremental difference in median progression-free survival among patients treated with trastuzumab was 8.6 months, based on a 17.9-month duration in the 20 patients who received trastuzumab and 9.3 months in 20 control patients on chemotherapy only (P = .013).
“We’ll push to have the trastuzumab, carboplatin, and paclitaxel regimen in the guidelines” for treating patients with USC that overexpresses HER2/neu, agreed Amanda N. Fader, MD, director of gynecologic oncology at Johns Hopkins Medicine in Baltimore and lead author on the study reported by Dr. Santin.
Shortly after Dr. Santin’s report at the meeting, the results appeared in an article published online March 27 in Journal of Clinical Oncology.
The phase 2 trial ran at 11 U.S. centers during 2011-2016, and randomized 61 patients with stage III or IV or recurrent USC and high HER2 protein expression measured by immunohistochemistry and amplification of the HER2 gene shown by fluorescence in situ hybridization. The researchers collected data from 58 treated patients. Among the 17 patients with recurrent disease, those who received trastuzumab had a median progression-free survival of 9.2 months compared with 6.0 months in the controls, a hazard reduction of 86% with trastuzumab that was statistically significant (P = .0029). The addition of trastuzumab to carboplatin and paclitaxel was well tolerated.
The greatest benefit from the trastuzumab plus chemotherapy regimen might occur when used as first-line treatment, Dr. Santin suggested. He expressed interest in running a second study to validate the current findings, and a new study that would combine a second antibody directed against HER2, pertuzumab (Perjeta) with trastuzumab, carboplatin, and paclitaxel.
A key factor in making the trastuzumab plus chemotherapy regimen more widely available to USC patients would be routinely screening these patients for high levels of HER2/neu expression immediately after USC is diagnosed. “At Yale and Johns Hopkins this testing is done on all USC patients. That’s not standard care everywhere, but it should be based on these data,” Dr. Santin said in an interview.
SOURCE: Fader A et al. Abstract 22. J Clin Oncol. 2018 Mar 27. doi: 10.1200/JCO.2017.76.5966.
NEW ORLEANS – Adding the anti-HER2 antibody trastuzumab to a standard chemotherapy regimen produced markedly improved responses among patients with an advanced stage or recurrent uterine serous carcinoma that also overexpressed the HER2/neu cell receptor protein in a controlled, multicenter, phase 2 study with 58 evaluable patients.
The 30 patients who received trastuzumab along with carboplatin plus paclitaxel had a median progression-free survival of 12.6 months compared with 8.0 months among the 28 control patients who received only carboplatin plus paclitaxel, a hazard reduction of 56% with trastuzumab that was statistically significant (P = .0052), Alessandro D. Santin, MD, said at the annual meeting of the Society of Gynecologic Oncology.
In the subgroup of 41 patients with advanced (not recurrent) uterine serous carcinoma (USC) the incremental difference in median progression-free survival among patients treated with trastuzumab was 8.6 months, based on a 17.9-month duration in the 20 patients who received trastuzumab and 9.3 months in 20 control patients on chemotherapy only (P = .013).
“We’ll push to have the trastuzumab, carboplatin, and paclitaxel regimen in the guidelines” for treating patients with USC that overexpresses HER2/neu, agreed Amanda N. Fader, MD, director of gynecologic oncology at Johns Hopkins Medicine in Baltimore and lead author on the study reported by Dr. Santin.
Shortly after Dr. Santin’s report at the meeting, the results appeared in an article published online March 27 in Journal of Clinical Oncology.
The phase 2 trial ran at 11 U.S. centers during 2011-2016, and randomized 61 patients with stage III or IV or recurrent USC and high HER2 protein expression measured by immunohistochemistry and amplification of the HER2 gene shown by fluorescence in situ hybridization. The researchers collected data from 58 treated patients. Among the 17 patients with recurrent disease, those who received trastuzumab had a median progression-free survival of 9.2 months compared with 6.0 months in the controls, a hazard reduction of 86% with trastuzumab that was statistically significant (P = .0029). The addition of trastuzumab to carboplatin and paclitaxel was well tolerated.
The greatest benefit from the trastuzumab plus chemotherapy regimen might occur when used as first-line treatment, Dr. Santin suggested. He expressed interest in running a second study to validate the current findings, and a new study that would combine a second antibody directed against HER2, pertuzumab (Perjeta) with trastuzumab, carboplatin, and paclitaxel.
A key factor in making the trastuzumab plus chemotherapy regimen more widely available to USC patients would be routinely screening these patients for high levels of HER2/neu expression immediately after USC is diagnosed. “At Yale and Johns Hopkins this testing is done on all USC patients. That’s not standard care everywhere, but it should be based on these data,” Dr. Santin said in an interview.
SOURCE: Fader A et al. Abstract 22. J Clin Oncol. 2018 Mar 27. doi: 10.1200/JCO.2017.76.5966.
REPORTING FROM SGO 2018
Key clinical point: Trastuzumab plus chemotherapy improved progression-free survival in a phase 2 study.
Major finding: Median progression-free survival was 12.6 months with trastuzumab and 8.0 months in controls.
Study details: A multicenter, phase 2 study that enrolled 58 evaluable patients.
Disclosures: Trastuzumab was provided at no charge by Genentech. Dr. Santin and Dr. Fader had no relevant disclosures.
Source: Fader A et al. Abstract 22. J Clin Oncol. 2018 Mar 27. doi: 10.1200/JCO.2017.76.5966)
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The biological relevance of HER2 amplification has been clearly established in the results from this and other studies. But we must keep in kind that the results reported by Dr. Santin have applicability to a subset of a subset of patients. Specifically, about 10% of endometrial cancers are uterine serous carcinoma (USC) (although they account for roughly 40% of deaths among endometrial cancer patients), about half of USC patients show a high level of HER2/neu expression by immunohistochemistry, and about 60% of these high-expressing USC also have HER2 gene amplification. The study presented by Dr. Santin ran at 11 centers for 5.5 years and enrolled just 61 patients, fewer than the planned enrollment target of 100 patients.
Michael A. Bookman, MD , is director of gynecologic oncology therapeutics at the Permanente Medical Group in San Francisco. He has been an adviser to AstraZeneca, Bayer, Clovis, Merck, Pfizer, and Tesaro, and he has participated in trials funded by Abbvie, Genentech, Immunogen, Mateon, and Roche. He made these comments as designated discussant for the study.
Myelodysplastic syndromes: etiologies, evaluation, and therapy
In this interview, Dr David Henry, MD, the Editor-in-Chief of JCSO, and David Steensma, MD, of the Dana-Farber Cancer Institute in Boston, talk about myelodysplasic syndromes, from diagnosis, evaluation, and etiologies, to therapy options and molecular sequencing.
Listen to the podcast below, or click on the PDF icon at the top of this introduction to read a transcript of the interview.
In this interview, Dr David Henry, MD, the Editor-in-Chief of JCSO, and David Steensma, MD, of the Dana-Farber Cancer Institute in Boston, talk about myelodysplasic syndromes, from diagnosis, evaluation, and etiologies, to therapy options and molecular sequencing.
Listen to the podcast below, or click on the PDF icon at the top of this introduction to read a transcript of the interview.
In this interview, Dr David Henry, MD, the Editor-in-Chief of JCSO, and David Steensma, MD, of the Dana-Farber Cancer Institute in Boston, talk about myelodysplasic syndromes, from diagnosis, evaluation, and etiologies, to therapy options and molecular sequencing.
Listen to the podcast below, or click on the PDF icon at the top of this introduction to read a transcript of the interview.
Estrogen patch counters eating disorders in women athletes
CHICAGO – It’s a good idea to look for eating disorders in young, athletic women who present with oligomenorrhea; they are at high risk for them and can be helped with estrogen replacement, especially with a patch, according to investigators from Massachusetts General Hospital, Boston.
Estrogen replacement will also help with stress fractures and other bone problems, but young, athletic women might resist the idea. They worry that it might hurt their performance and are often proud that they work out hard enough to stop their periods, according to investigator Vibha Singhal, MD, a pediatric endocrinologist and eating disorder specialist at the hospital.
Earlier research done at Massachusetts General had shown that replacing estrogen to physiological levels helped reduce anxiety and body dissatisfaction in anorexia nervosa. Both are key drivers of the condition, along with the drive for thinness, lead investigator Franziska Plessow, PhD, a neuroendocrine researcher at the hospital, said at the Endocrine Society’s annual meeting.
But the researchers wondered whether estrogen also helps healthy weight women with nascent eating disorders, so the investigators turned to female athletes aged 14-25 years who had stopped menstruating or were about to.
The 117 oligomenorrheic athletes (OA) they investigated – none of whom had formally diagnosed eating disorders – scored significantly higher on measures of body dissatisfaction, drive for thinness, perfectionism, and “cognitive restraint of eating,” compared with 50 female athletes and 41 nonathletic women, both with normal periods. For instance, OA women scored a mean of 4.21 on the drive for thinness scale of the Eating Disorder Inventory–2, a low score, but still significantly higher than the 1.66 points in eumenorrheic athletes and 1.61 points in nonathletes (P = .0005).
Oligomenorrheic female athletes “show more disordered eating behavior and psychopathology at the subclinical level,” Dr. Plessow said.
Seventy OA women were then randomized to three groups: 25 to physiological estrogen replacement with an estradiol patch and cyclic progesterone for 12 days/month; 19 to replacement with contraceptive pills on the standard monthly schedule; and 26 to no replacement.
Over 12 months, women on the patch dropped their drive for thinness, body dissatisfaction, and uncontrolled eating scores. Body dissatisfaction scores on the Eating Disorder Inventory–2, for example, fell about two points, compared with staying about the same in the pill group and increasing by about two points in the no-estrogen group.
The pill seemed to help a bit on some measures, too, but the benefit of the pill versus that of no estrogen wasn’t generally statistically significant. Meanwhile, symptoms worsened in women who didn’t get estrogen. “The practice right now is the pill. We are shifting our practice with these data to the patch,” Dr. Singhal said.
Overall, “these findings emphasize the importance of normalizing estrogen levels in this population,” she and her colleagues concluded.
It’s a mystery why estrogen helps with eating disorders. Maybe it has something to do with the estrogen receptors in the appetite centers of the brain. Maybe the patch works better than the pill because there’s no first-pass through the liver, Dr. Singhal said.
Subjects were aged about 20 years, on average. OA women had a mean body mass index of 20.6 kg/m2 and a mean estradiol level of 45 pg/mL. Subjects with regular periods had mean BMIs of about 22 kg/m2; mean estradiol levels were 70.2 pg/mL in eumenorrheic athletes and 83.6 pg/mL in nonathletic women.
The work was funded by the National Institutes of Health. The investigators didn’t have any relevant disclosures.
SOURCE: Plessow F et al. ENDO 2018, Abstract SAT-290.
CHICAGO – It’s a good idea to look for eating disorders in young, athletic women who present with oligomenorrhea; they are at high risk for them and can be helped with estrogen replacement, especially with a patch, according to investigators from Massachusetts General Hospital, Boston.
Estrogen replacement will also help with stress fractures and other bone problems, but young, athletic women might resist the idea. They worry that it might hurt their performance and are often proud that they work out hard enough to stop their periods, according to investigator Vibha Singhal, MD, a pediatric endocrinologist and eating disorder specialist at the hospital.
Earlier research done at Massachusetts General had shown that replacing estrogen to physiological levels helped reduce anxiety and body dissatisfaction in anorexia nervosa. Both are key drivers of the condition, along with the drive for thinness, lead investigator Franziska Plessow, PhD, a neuroendocrine researcher at the hospital, said at the Endocrine Society’s annual meeting.
But the researchers wondered whether estrogen also helps healthy weight women with nascent eating disorders, so the investigators turned to female athletes aged 14-25 years who had stopped menstruating or were about to.
The 117 oligomenorrheic athletes (OA) they investigated – none of whom had formally diagnosed eating disorders – scored significantly higher on measures of body dissatisfaction, drive for thinness, perfectionism, and “cognitive restraint of eating,” compared with 50 female athletes and 41 nonathletic women, both with normal periods. For instance, OA women scored a mean of 4.21 on the drive for thinness scale of the Eating Disorder Inventory–2, a low score, but still significantly higher than the 1.66 points in eumenorrheic athletes and 1.61 points in nonathletes (P = .0005).
Oligomenorrheic female athletes “show more disordered eating behavior and psychopathology at the subclinical level,” Dr. Plessow said.
Seventy OA women were then randomized to three groups: 25 to physiological estrogen replacement with an estradiol patch and cyclic progesterone for 12 days/month; 19 to replacement with contraceptive pills on the standard monthly schedule; and 26 to no replacement.
Over 12 months, women on the patch dropped their drive for thinness, body dissatisfaction, and uncontrolled eating scores. Body dissatisfaction scores on the Eating Disorder Inventory–2, for example, fell about two points, compared with staying about the same in the pill group and increasing by about two points in the no-estrogen group.
The pill seemed to help a bit on some measures, too, but the benefit of the pill versus that of no estrogen wasn’t generally statistically significant. Meanwhile, symptoms worsened in women who didn’t get estrogen. “The practice right now is the pill. We are shifting our practice with these data to the patch,” Dr. Singhal said.
Overall, “these findings emphasize the importance of normalizing estrogen levels in this population,” she and her colleagues concluded.
It’s a mystery why estrogen helps with eating disorders. Maybe it has something to do with the estrogen receptors in the appetite centers of the brain. Maybe the patch works better than the pill because there’s no first-pass through the liver, Dr. Singhal said.
Subjects were aged about 20 years, on average. OA women had a mean body mass index of 20.6 kg/m2 and a mean estradiol level of 45 pg/mL. Subjects with regular periods had mean BMIs of about 22 kg/m2; mean estradiol levels were 70.2 pg/mL in eumenorrheic athletes and 83.6 pg/mL in nonathletic women.
The work was funded by the National Institutes of Health. The investigators didn’t have any relevant disclosures.
SOURCE: Plessow F et al. ENDO 2018, Abstract SAT-290.
CHICAGO – It’s a good idea to look for eating disorders in young, athletic women who present with oligomenorrhea; they are at high risk for them and can be helped with estrogen replacement, especially with a patch, according to investigators from Massachusetts General Hospital, Boston.
Estrogen replacement will also help with stress fractures and other bone problems, but young, athletic women might resist the idea. They worry that it might hurt their performance and are often proud that they work out hard enough to stop their periods, according to investigator Vibha Singhal, MD, a pediatric endocrinologist and eating disorder specialist at the hospital.
Earlier research done at Massachusetts General had shown that replacing estrogen to physiological levels helped reduce anxiety and body dissatisfaction in anorexia nervosa. Both are key drivers of the condition, along with the drive for thinness, lead investigator Franziska Plessow, PhD, a neuroendocrine researcher at the hospital, said at the Endocrine Society’s annual meeting.
But the researchers wondered whether estrogen also helps healthy weight women with nascent eating disorders, so the investigators turned to female athletes aged 14-25 years who had stopped menstruating or were about to.
The 117 oligomenorrheic athletes (OA) they investigated – none of whom had formally diagnosed eating disorders – scored significantly higher on measures of body dissatisfaction, drive for thinness, perfectionism, and “cognitive restraint of eating,” compared with 50 female athletes and 41 nonathletic women, both with normal periods. For instance, OA women scored a mean of 4.21 on the drive for thinness scale of the Eating Disorder Inventory–2, a low score, but still significantly higher than the 1.66 points in eumenorrheic athletes and 1.61 points in nonathletes (P = .0005).
Oligomenorrheic female athletes “show more disordered eating behavior and psychopathology at the subclinical level,” Dr. Plessow said.
Seventy OA women were then randomized to three groups: 25 to physiological estrogen replacement with an estradiol patch and cyclic progesterone for 12 days/month; 19 to replacement with contraceptive pills on the standard monthly schedule; and 26 to no replacement.
Over 12 months, women on the patch dropped their drive for thinness, body dissatisfaction, and uncontrolled eating scores. Body dissatisfaction scores on the Eating Disorder Inventory–2, for example, fell about two points, compared with staying about the same in the pill group and increasing by about two points in the no-estrogen group.
The pill seemed to help a bit on some measures, too, but the benefit of the pill versus that of no estrogen wasn’t generally statistically significant. Meanwhile, symptoms worsened in women who didn’t get estrogen. “The practice right now is the pill. We are shifting our practice with these data to the patch,” Dr. Singhal said.
Overall, “these findings emphasize the importance of normalizing estrogen levels in this population,” she and her colleagues concluded.
It’s a mystery why estrogen helps with eating disorders. Maybe it has something to do with the estrogen receptors in the appetite centers of the brain. Maybe the patch works better than the pill because there’s no first-pass through the liver, Dr. Singhal said.
Subjects were aged about 20 years, on average. OA women had a mean body mass index of 20.6 kg/m2 and a mean estradiol level of 45 pg/mL. Subjects with regular periods had mean BMIs of about 22 kg/m2; mean estradiol levels were 70.2 pg/mL in eumenorrheic athletes and 83.6 pg/mL in nonathletic women.
The work was funded by the National Institutes of Health. The investigators didn’t have any relevant disclosures.
SOURCE: Plessow F et al. ENDO 2018, Abstract SAT-290.
REPORTING FROM ENDO 2018
Key clinical point: It’s a good idea to look for eating disorders in young, athletic women who present with oligo-amenorrhea; they’re at high risk for them and can be helped with estrogen replacement, especially with a patch.
Major finding: Over 12 months, body dissatisfaction scores fell about 2 points among women on the patch, versus staying about the same in the pill group, and increasing about 2 points in the no-estrogen group.
Study details: Combined cross-sectional and randomized investigation
Disclosures: The work was supported by the National Institutes of Health. The investigators didn’t have any disclosures.
Source: Plessow F et al. ENDO 2018 abstract SAT-290
Complication rates rise after decline in uterine fibroid morcellation
The rate of major and minor 30-day complications from the treatment of uterine fibroids has increased significantly since the Food and Drug Administration’s black-box warning against the use of power morcellation, data suggest.
Researchers examined the incidence of 30-day posthysterectomy complications in 75,487 women who underwent treatment for benign gynecologic indications before and after November 2014, when the FDA’s edict was issued over concerns about the risk of disseminating benign or malignant disease. Of these women, 25,571 had uterine fibroids as the indication for hysterectomy.
The retrospective cohort study, published online April 11 in JAMA Surgery, showed that while the overall rate of complications in the cohort was relatively unchanged before and after the FDA’s warning, complication rates increased significantly in women undergoing treatment for uterine fibroids.
Before the FDA’s announcement, the 30-day major complication rate in women undergoing hysterectomy for uterine fibroids was 1.9%, which increased to 2.4% after the FDA’s warning (odds ratio, 1.23; 95% confidence interval, 1.04-1.47; P = .02). Similarly, the rate of minor 30-day complications increased from 2.7% before the warning to 3.3% after the warning (OR, 1.21; 95% CI, 1.04-1.40; P = .01), after adjustment for factors such as age, body mass index, comorbidities, and other associated procedures.
“This 20% increase in the odds of major and minor complications could translate into a large number of additional complications among the 200,000 hysterectomies performed annually for uterine fibroids in the United States,” wrote Francesco Multinu, MD, of the department of obstetrics and gynecology at the Mayo Clinic, Rochester, Minn., and his coauthors.
Overall, the researchers saw a much higher rate of major complications in women undergoing open abdominal surgery, compared with women who underwent minimally invasive surgery or vaginal hysterectomy (3.5% vs. 1.7% vs. 1.7%). A similar pattern was seen in the subgroup of women who underwent hysterectomy for uterine fibroids (2.8% vs. 1.8% vs. 1.8%).
However, minor 30-day complication rates were higher in women who underwent vaginal hysterectomy (4.5%), compared with open abdominal surgery (4.1%) and minimally invasive surgery (3.2%). In women with uterine fibroids, the minor complication rates were slightly higher in those who underwent open hysterectomy or vaginal hysterectomy than in those who had minimally invasive surgery, but this was not statistically significant.
The type of surgery in women with uterine fibroids changed significantly after the FDA announcement. Before the black-box warning against power morcellation was issued, 37.2% of hysterectomy procedures for uterine fibroids were open, 56.1% were minimally invasive, and 6.7% were vaginal. After the announcement, the percentage that were open procedures increased to 43%, minimally invasive procedures decreased to 49.7%, and vaginal hysterectomies increased to 7.3% (P less than .001).
A similar but less pronounced trend was seen across all hysterectomies for benign gynecological indications.
The authors noted that the study analyzed data on 30-day complications, so they weren’t able to draw conclusions about longer-term outcomes.
“Although caution is required to avoid morcellation of unexpected uterine malignant neoplasms, our results should be considered by women and clinicians during the process of shared decision making and by medical societies and regulatory bodies when issuing safety communications,” the authors wrote.
The study was supported by a grant from the National Center for Advancing Translational Sciences, and one author was supported by the University of Insubria, and by Fondo Miglierina, Varese, Italy. No conflicts of interest were declared.
SOURCE: Multinu F et al. JAMA Surg. 2018 Apr 11. doi: 10.1001/jamasurg.2018.0141.
The rate of major and minor 30-day complications from the treatment of uterine fibroids has increased significantly since the Food and Drug Administration’s black-box warning against the use of power morcellation, data suggest.
Researchers examined the incidence of 30-day posthysterectomy complications in 75,487 women who underwent treatment for benign gynecologic indications before and after November 2014, when the FDA’s edict was issued over concerns about the risk of disseminating benign or malignant disease. Of these women, 25,571 had uterine fibroids as the indication for hysterectomy.
The retrospective cohort study, published online April 11 in JAMA Surgery, showed that while the overall rate of complications in the cohort was relatively unchanged before and after the FDA’s warning, complication rates increased significantly in women undergoing treatment for uterine fibroids.
Before the FDA’s announcement, the 30-day major complication rate in women undergoing hysterectomy for uterine fibroids was 1.9%, which increased to 2.4% after the FDA’s warning (odds ratio, 1.23; 95% confidence interval, 1.04-1.47; P = .02). Similarly, the rate of minor 30-day complications increased from 2.7% before the warning to 3.3% after the warning (OR, 1.21; 95% CI, 1.04-1.40; P = .01), after adjustment for factors such as age, body mass index, comorbidities, and other associated procedures.
“This 20% increase in the odds of major and minor complications could translate into a large number of additional complications among the 200,000 hysterectomies performed annually for uterine fibroids in the United States,” wrote Francesco Multinu, MD, of the department of obstetrics and gynecology at the Mayo Clinic, Rochester, Minn., and his coauthors.
Overall, the researchers saw a much higher rate of major complications in women undergoing open abdominal surgery, compared with women who underwent minimally invasive surgery or vaginal hysterectomy (3.5% vs. 1.7% vs. 1.7%). A similar pattern was seen in the subgroup of women who underwent hysterectomy for uterine fibroids (2.8% vs. 1.8% vs. 1.8%).
However, minor 30-day complication rates were higher in women who underwent vaginal hysterectomy (4.5%), compared with open abdominal surgery (4.1%) and minimally invasive surgery (3.2%). In women with uterine fibroids, the minor complication rates were slightly higher in those who underwent open hysterectomy or vaginal hysterectomy than in those who had minimally invasive surgery, but this was not statistically significant.
The type of surgery in women with uterine fibroids changed significantly after the FDA announcement. Before the black-box warning against power morcellation was issued, 37.2% of hysterectomy procedures for uterine fibroids were open, 56.1% were minimally invasive, and 6.7% were vaginal. After the announcement, the percentage that were open procedures increased to 43%, minimally invasive procedures decreased to 49.7%, and vaginal hysterectomies increased to 7.3% (P less than .001).
A similar but less pronounced trend was seen across all hysterectomies for benign gynecological indications.
The authors noted that the study analyzed data on 30-day complications, so they weren’t able to draw conclusions about longer-term outcomes.
“Although caution is required to avoid morcellation of unexpected uterine malignant neoplasms, our results should be considered by women and clinicians during the process of shared decision making and by medical societies and regulatory bodies when issuing safety communications,” the authors wrote.
The study was supported by a grant from the National Center for Advancing Translational Sciences, and one author was supported by the University of Insubria, and by Fondo Miglierina, Varese, Italy. No conflicts of interest were declared.
SOURCE: Multinu F et al. JAMA Surg. 2018 Apr 11. doi: 10.1001/jamasurg.2018.0141.
The rate of major and minor 30-day complications from the treatment of uterine fibroids has increased significantly since the Food and Drug Administration’s black-box warning against the use of power morcellation, data suggest.
Researchers examined the incidence of 30-day posthysterectomy complications in 75,487 women who underwent treatment for benign gynecologic indications before and after November 2014, when the FDA’s edict was issued over concerns about the risk of disseminating benign or malignant disease. Of these women, 25,571 had uterine fibroids as the indication for hysterectomy.
The retrospective cohort study, published online April 11 in JAMA Surgery, showed that while the overall rate of complications in the cohort was relatively unchanged before and after the FDA’s warning, complication rates increased significantly in women undergoing treatment for uterine fibroids.
Before the FDA’s announcement, the 30-day major complication rate in women undergoing hysterectomy for uterine fibroids was 1.9%, which increased to 2.4% after the FDA’s warning (odds ratio, 1.23; 95% confidence interval, 1.04-1.47; P = .02). Similarly, the rate of minor 30-day complications increased from 2.7% before the warning to 3.3% after the warning (OR, 1.21; 95% CI, 1.04-1.40; P = .01), after adjustment for factors such as age, body mass index, comorbidities, and other associated procedures.
“This 20% increase in the odds of major and minor complications could translate into a large number of additional complications among the 200,000 hysterectomies performed annually for uterine fibroids in the United States,” wrote Francesco Multinu, MD, of the department of obstetrics and gynecology at the Mayo Clinic, Rochester, Minn., and his coauthors.
Overall, the researchers saw a much higher rate of major complications in women undergoing open abdominal surgery, compared with women who underwent minimally invasive surgery or vaginal hysterectomy (3.5% vs. 1.7% vs. 1.7%). A similar pattern was seen in the subgroup of women who underwent hysterectomy for uterine fibroids (2.8% vs. 1.8% vs. 1.8%).
However, minor 30-day complication rates were higher in women who underwent vaginal hysterectomy (4.5%), compared with open abdominal surgery (4.1%) and minimally invasive surgery (3.2%). In women with uterine fibroids, the minor complication rates were slightly higher in those who underwent open hysterectomy or vaginal hysterectomy than in those who had minimally invasive surgery, but this was not statistically significant.
The type of surgery in women with uterine fibroids changed significantly after the FDA announcement. Before the black-box warning against power morcellation was issued, 37.2% of hysterectomy procedures for uterine fibroids were open, 56.1% were minimally invasive, and 6.7% were vaginal. After the announcement, the percentage that were open procedures increased to 43%, minimally invasive procedures decreased to 49.7%, and vaginal hysterectomies increased to 7.3% (P less than .001).
A similar but less pronounced trend was seen across all hysterectomies for benign gynecological indications.
The authors noted that the study analyzed data on 30-day complications, so they weren’t able to draw conclusions about longer-term outcomes.
“Although caution is required to avoid morcellation of unexpected uterine malignant neoplasms, our results should be considered by women and clinicians during the process of shared decision making and by medical societies and regulatory bodies when issuing safety communications,” the authors wrote.
The study was supported by a grant from the National Center for Advancing Translational Sciences, and one author was supported by the University of Insubria, and by Fondo Miglierina, Varese, Italy. No conflicts of interest were declared.
SOURCE: Multinu F et al. JAMA Surg. 2018 Apr 11. doi: 10.1001/jamasurg.2018.0141.
FROM JAMA SURGERY
Key clinical point: Major complications from uterine fibroid hysterectomies have increased with more open surgeries.
Major finding: The rate of 30-day complications after uterine fibroid hysterectomy has increased by 20%.
Study details: A retrospective cohort study of 75,487 women.
Disclosures: The study was supported by a grant from the National Center for Advancing Translational Sciences, a component of the National Institutes of Health, and one author was supported by the University of Insubria, and by Fondo Miglierina, Varese, Italy. No conflicts of interest were declared.
Source: Multinu F et al. JAMA Surg. 2018 Apr 11. doi: 10.1001/jamasurg.2018.0141.
Risk of ED visit/hospitalization increases when brand-name angiotensin receptor blockers (ARB) are switched to generic versions
Clinical question: Does switching from a brand name ARB to its generic lead to more ED visits and hospitalizations?
Background: Once a brand name drug’s patent expires, its generic form is commercialized and patients may be switched to the generic version. The drug equivalence of the generic vs. the brand name product may be substantial enough to affect clinically what is happening to the patient. Very few studies exist on the impact of the differences between brand-name and generic ARBs; those that do exist show conflicting results on clinical outcomes for the patient.
Study design: Observational retrospective interrupted time–series analysis.
Setting: Quebec Integrated Chronic Disease Surveillance System in Quebec.
Synopsis: The study analyzed 136,177 patients older than 66 years old with multiple comorbidities during the transition from brand-name to generic versions of losartan, valsartan, and candesartan. The authors compared ER visits or hospitalization of the brand-name users for 24 months before and 12 months after being transitioned from a brand-name ARB to a generic. All three groups were found to have higher rates of adverse events after switching to generics (8% for losartan, 11.7% for valsartan, and 16.6% for candesartan). The study was limited as the authors did not have access to the reason for the ER visits/admissions or the ability to determine which generic version was used (e.g., losartan has eight generic versions). The study highlights the need for further evaluation by risk and survival analysis to control confounders when switching to a generic formulation.
Bottom line: Switching patients from a brand-name to a generic ARB may lead to more ED consultations and hospital admissions.
Citation: Leclerc J et al. Impact of the commercialization of three generic angiotensin II receptor blockers on adverse events in Quebec Canada. Circ Cardiovasc Qual Outcomes. 2017 Oct 3. pii 10e003891. doi: 10.1161/circoutcomes.117.003891.
Dr. Smith is assistant professor of medicine in the Division of Hospital Medicine, Emory University, Atlanta.
Clinical question: Does switching from a brand name ARB to its generic lead to more ED visits and hospitalizations?
Background: Once a brand name drug’s patent expires, its generic form is commercialized and patients may be switched to the generic version. The drug equivalence of the generic vs. the brand name product may be substantial enough to affect clinically what is happening to the patient. Very few studies exist on the impact of the differences between brand-name and generic ARBs; those that do exist show conflicting results on clinical outcomes for the patient.
Study design: Observational retrospective interrupted time–series analysis.
Setting: Quebec Integrated Chronic Disease Surveillance System in Quebec.
Synopsis: The study analyzed 136,177 patients older than 66 years old with multiple comorbidities during the transition from brand-name to generic versions of losartan, valsartan, and candesartan. The authors compared ER visits or hospitalization of the brand-name users for 24 months before and 12 months after being transitioned from a brand-name ARB to a generic. All three groups were found to have higher rates of adverse events after switching to generics (8% for losartan, 11.7% for valsartan, and 16.6% for candesartan). The study was limited as the authors did not have access to the reason for the ER visits/admissions or the ability to determine which generic version was used (e.g., losartan has eight generic versions). The study highlights the need for further evaluation by risk and survival analysis to control confounders when switching to a generic formulation.
Bottom line: Switching patients from a brand-name to a generic ARB may lead to more ED consultations and hospital admissions.
Citation: Leclerc J et al. Impact of the commercialization of three generic angiotensin II receptor blockers on adverse events in Quebec Canada. Circ Cardiovasc Qual Outcomes. 2017 Oct 3. pii 10e003891. doi: 10.1161/circoutcomes.117.003891.
Dr. Smith is assistant professor of medicine in the Division of Hospital Medicine, Emory University, Atlanta.
Clinical question: Does switching from a brand name ARB to its generic lead to more ED visits and hospitalizations?
Background: Once a brand name drug’s patent expires, its generic form is commercialized and patients may be switched to the generic version. The drug equivalence of the generic vs. the brand name product may be substantial enough to affect clinically what is happening to the patient. Very few studies exist on the impact of the differences between brand-name and generic ARBs; those that do exist show conflicting results on clinical outcomes for the patient.
Study design: Observational retrospective interrupted time–series analysis.
Setting: Quebec Integrated Chronic Disease Surveillance System in Quebec.
Synopsis: The study analyzed 136,177 patients older than 66 years old with multiple comorbidities during the transition from brand-name to generic versions of losartan, valsartan, and candesartan. The authors compared ER visits or hospitalization of the brand-name users for 24 months before and 12 months after being transitioned from a brand-name ARB to a generic. All three groups were found to have higher rates of adverse events after switching to generics (8% for losartan, 11.7% for valsartan, and 16.6% for candesartan). The study was limited as the authors did not have access to the reason for the ER visits/admissions or the ability to determine which generic version was used (e.g., losartan has eight generic versions). The study highlights the need for further evaluation by risk and survival analysis to control confounders when switching to a generic formulation.
Bottom line: Switching patients from a brand-name to a generic ARB may lead to more ED consultations and hospital admissions.
Citation: Leclerc J et al. Impact of the commercialization of three generic angiotensin II receptor blockers on adverse events in Quebec Canada. Circ Cardiovasc Qual Outcomes. 2017 Oct 3. pii 10e003891. doi: 10.1161/circoutcomes.117.003891.
Dr. Smith is assistant professor of medicine in the Division of Hospital Medicine, Emory University, Atlanta.
Can adhesive small bowel obstructions be addressed laparoscopically?
LAS VEGAS – whether they are open or laparoscopic. Small bowel obstructions can result, and management decisions can be complex. What if the patient resolves? Should you offer elective adhesiolysis? If it doesn’t resolve, can the surgery be done laparoscopically or should the procedure be open?
Bradley R. Davis, MD, FACS, discussed some of these options, and the case circumstances that inform the surgeon’s choices at the Annual Minimally Invasive Surgery Symposium by -Global Academy for Medical Education. Dr. Davis is chief of general surgery and of rectal surgery at Carolinas Medical Center, Charlotte, N.C.
Laparoscopic surgeries are associated with significantly lower rates of small bowel obstruction, but it can still happen. More often, patients will have had a previous open surgery, and this should be a selling point for doing first-time surgeries using minimally invasive techniques. “That’s one thing I tell my patients when I see them in the office. There’s a real reduction in adhesive small bowel obstruction and certainly in hernia formation, so there are long-term benefits that I don’t think we talk enough about,” said Dr. Davis.
Although the majority of obstructions are caused by adhesions, some are the result of malignancies or hernias, and Dr. Davis encourages his residents to do exams to determine if a hernia is to blame. “That’s harder and harder to do now that everyone does a CT scan, but that’s always an interesting question to ask a resident,” he said. Inflammatory bowel disease is sometimes also a cause, but that’s rare.
CT scans are the diagnostic mode of choice for small bowel obstructions. Some believe that oral contrast agents may help resolve obstructions, but Dr. Davis mentioned evidence from a study showing that contrast agents don’t change the course of obstructions or reduce laparotomy rates. However, contrast agents can help predict the clinical course of an obstruction. If the contrast agent is present in the colon at 24 hours, then that predicts that the patient will resolve with conservative treatment. “You have a pretty good idea that the patient is going to get better,” said Dr. Davis.
The American Association for the Surgery of Trauma severity grade is helpful for adhesive small bowel obstructions. Grade 2 cases involve intestinal distension and possibly a transition zone, some passage of contrast on follow-up films, and no evidence of intestinal compromise. Grade 3 cases have no distal contrast flow and evidence of complete obstruction or impending bowel compromise. In the latter cases, “we’re scratching our heads wondering whether to take the patient to the operating room. Certainly most of these cases we’ll manage initially nonoperatively, but those patients will end up getting an earlier operation,” said Dr. Davis.
The majority of surgeries are adhesiolysis, sometimes with a bowel resection. Whether or not the surgery can be performed laparoscopically or as an open surgery depends on several factors. If the index operation was done laparoscopically, chances are good that the adhesiolysis can be performed the same way. On the other hand, “if a patient has a known hostile abdomen, I wouldn’t even try. I would basically go straight to an open procedure,” said Dr. Davis.
Generally speaking, though, reoperative surgeries can be attempted laparoscopically and then converted to open procedures if needed, he added. The most common reasons for conversion are dense adhesions and ischemia-related resection.
However, iatrogenic injuries can also occur as a result of trocar access. “Just keep in mind that if you put the trocar into the bowel, the worst thing you can do is take it out because you won’t always find that hole. Just leave the trocar in the bowel, convert to an open procedure, and find the hole and fix it,” said Dr. Davis.
Cases are particularly challenging when the transition zone is in the pelvis. Those procedures are difficult to do laparoscopically because of a difficult angle, and they are more likely to convert to open surgery. “To be honest, that’s not an easy operation to open either, so beware that transition zone in the pelvis can be a difficult case.
“I don’t try to do anything heroic laparoscopically. If you put a camera in and you find it’s going to be a massive adhesiolysis laparoscopically, you might just be better off to open,” said Dr. Davis. In cases like that it can be hard to find the transition zone, which must be identified in order to ensure that the underlying problem is fixed.
An aggressive option in difficult cases is to use a PEEK Port, which starts with a 6-8 cm incision. The surgeon can open up a minimum of disposables and put a hand in to assist the laparoscopic view and determine if the procedure can be completed laparoscopically. “If you encounter extensive adhesions, you just convert to a laparotomy and you haven’t lost any time or spent any money in terms of disposables,” he said.
Dr. Davis had no disclosures. Global Academy for Medical Education and this news organization are owned by the same parent company.
LAS VEGAS – whether they are open or laparoscopic. Small bowel obstructions can result, and management decisions can be complex. What if the patient resolves? Should you offer elective adhesiolysis? If it doesn’t resolve, can the surgery be done laparoscopically or should the procedure be open?
Bradley R. Davis, MD, FACS, discussed some of these options, and the case circumstances that inform the surgeon’s choices at the Annual Minimally Invasive Surgery Symposium by -Global Academy for Medical Education. Dr. Davis is chief of general surgery and of rectal surgery at Carolinas Medical Center, Charlotte, N.C.
Laparoscopic surgeries are associated with significantly lower rates of small bowel obstruction, but it can still happen. More often, patients will have had a previous open surgery, and this should be a selling point for doing first-time surgeries using minimally invasive techniques. “That’s one thing I tell my patients when I see them in the office. There’s a real reduction in adhesive small bowel obstruction and certainly in hernia formation, so there are long-term benefits that I don’t think we talk enough about,” said Dr. Davis.
Although the majority of obstructions are caused by adhesions, some are the result of malignancies or hernias, and Dr. Davis encourages his residents to do exams to determine if a hernia is to blame. “That’s harder and harder to do now that everyone does a CT scan, but that’s always an interesting question to ask a resident,” he said. Inflammatory bowel disease is sometimes also a cause, but that’s rare.
CT scans are the diagnostic mode of choice for small bowel obstructions. Some believe that oral contrast agents may help resolve obstructions, but Dr. Davis mentioned evidence from a study showing that contrast agents don’t change the course of obstructions or reduce laparotomy rates. However, contrast agents can help predict the clinical course of an obstruction. If the contrast agent is present in the colon at 24 hours, then that predicts that the patient will resolve with conservative treatment. “You have a pretty good idea that the patient is going to get better,” said Dr. Davis.
The American Association for the Surgery of Trauma severity grade is helpful for adhesive small bowel obstructions. Grade 2 cases involve intestinal distension and possibly a transition zone, some passage of contrast on follow-up films, and no evidence of intestinal compromise. Grade 3 cases have no distal contrast flow and evidence of complete obstruction or impending bowel compromise. In the latter cases, “we’re scratching our heads wondering whether to take the patient to the operating room. Certainly most of these cases we’ll manage initially nonoperatively, but those patients will end up getting an earlier operation,” said Dr. Davis.
The majority of surgeries are adhesiolysis, sometimes with a bowel resection. Whether or not the surgery can be performed laparoscopically or as an open surgery depends on several factors. If the index operation was done laparoscopically, chances are good that the adhesiolysis can be performed the same way. On the other hand, “if a patient has a known hostile abdomen, I wouldn’t even try. I would basically go straight to an open procedure,” said Dr. Davis.
Generally speaking, though, reoperative surgeries can be attempted laparoscopically and then converted to open procedures if needed, he added. The most common reasons for conversion are dense adhesions and ischemia-related resection.
However, iatrogenic injuries can also occur as a result of trocar access. “Just keep in mind that if you put the trocar into the bowel, the worst thing you can do is take it out because you won’t always find that hole. Just leave the trocar in the bowel, convert to an open procedure, and find the hole and fix it,” said Dr. Davis.
Cases are particularly challenging when the transition zone is in the pelvis. Those procedures are difficult to do laparoscopically because of a difficult angle, and they are more likely to convert to open surgery. “To be honest, that’s not an easy operation to open either, so beware that transition zone in the pelvis can be a difficult case.
“I don’t try to do anything heroic laparoscopically. If you put a camera in and you find it’s going to be a massive adhesiolysis laparoscopically, you might just be better off to open,” said Dr. Davis. In cases like that it can be hard to find the transition zone, which must be identified in order to ensure that the underlying problem is fixed.
An aggressive option in difficult cases is to use a PEEK Port, which starts with a 6-8 cm incision. The surgeon can open up a minimum of disposables and put a hand in to assist the laparoscopic view and determine if the procedure can be completed laparoscopically. “If you encounter extensive adhesions, you just convert to a laparotomy and you haven’t lost any time or spent any money in terms of disposables,” he said.
Dr. Davis had no disclosures. Global Academy for Medical Education and this news organization are owned by the same parent company.
LAS VEGAS – whether they are open or laparoscopic. Small bowel obstructions can result, and management decisions can be complex. What if the patient resolves? Should you offer elective adhesiolysis? If it doesn’t resolve, can the surgery be done laparoscopically or should the procedure be open?
Bradley R. Davis, MD, FACS, discussed some of these options, and the case circumstances that inform the surgeon’s choices at the Annual Minimally Invasive Surgery Symposium by -Global Academy for Medical Education. Dr. Davis is chief of general surgery and of rectal surgery at Carolinas Medical Center, Charlotte, N.C.
Laparoscopic surgeries are associated with significantly lower rates of small bowel obstruction, but it can still happen. More often, patients will have had a previous open surgery, and this should be a selling point for doing first-time surgeries using minimally invasive techniques. “That’s one thing I tell my patients when I see them in the office. There’s a real reduction in adhesive small bowel obstruction and certainly in hernia formation, so there are long-term benefits that I don’t think we talk enough about,” said Dr. Davis.
Although the majority of obstructions are caused by adhesions, some are the result of malignancies or hernias, and Dr. Davis encourages his residents to do exams to determine if a hernia is to blame. “That’s harder and harder to do now that everyone does a CT scan, but that’s always an interesting question to ask a resident,” he said. Inflammatory bowel disease is sometimes also a cause, but that’s rare.
CT scans are the diagnostic mode of choice for small bowel obstructions. Some believe that oral contrast agents may help resolve obstructions, but Dr. Davis mentioned evidence from a study showing that contrast agents don’t change the course of obstructions or reduce laparotomy rates. However, contrast agents can help predict the clinical course of an obstruction. If the contrast agent is present in the colon at 24 hours, then that predicts that the patient will resolve with conservative treatment. “You have a pretty good idea that the patient is going to get better,” said Dr. Davis.
The American Association for the Surgery of Trauma severity grade is helpful for adhesive small bowel obstructions. Grade 2 cases involve intestinal distension and possibly a transition zone, some passage of contrast on follow-up films, and no evidence of intestinal compromise. Grade 3 cases have no distal contrast flow and evidence of complete obstruction or impending bowel compromise. In the latter cases, “we’re scratching our heads wondering whether to take the patient to the operating room. Certainly most of these cases we’ll manage initially nonoperatively, but those patients will end up getting an earlier operation,” said Dr. Davis.
The majority of surgeries are adhesiolysis, sometimes with a bowel resection. Whether or not the surgery can be performed laparoscopically or as an open surgery depends on several factors. If the index operation was done laparoscopically, chances are good that the adhesiolysis can be performed the same way. On the other hand, “if a patient has a known hostile abdomen, I wouldn’t even try. I would basically go straight to an open procedure,” said Dr. Davis.
Generally speaking, though, reoperative surgeries can be attempted laparoscopically and then converted to open procedures if needed, he added. The most common reasons for conversion are dense adhesions and ischemia-related resection.
However, iatrogenic injuries can also occur as a result of trocar access. “Just keep in mind that if you put the trocar into the bowel, the worst thing you can do is take it out because you won’t always find that hole. Just leave the trocar in the bowel, convert to an open procedure, and find the hole and fix it,” said Dr. Davis.
Cases are particularly challenging when the transition zone is in the pelvis. Those procedures are difficult to do laparoscopically because of a difficult angle, and they are more likely to convert to open surgery. “To be honest, that’s not an easy operation to open either, so beware that transition zone in the pelvis can be a difficult case.
“I don’t try to do anything heroic laparoscopically. If you put a camera in and you find it’s going to be a massive adhesiolysis laparoscopically, you might just be better off to open,” said Dr. Davis. In cases like that it can be hard to find the transition zone, which must be identified in order to ensure that the underlying problem is fixed.
An aggressive option in difficult cases is to use a PEEK Port, which starts with a 6-8 cm incision. The surgeon can open up a minimum of disposables and put a hand in to assist the laparoscopic view and determine if the procedure can be completed laparoscopically. “If you encounter extensive adhesions, you just convert to a laparotomy and you haven’t lost any time or spent any money in terms of disposables,” he said.
Dr. Davis had no disclosures. Global Academy for Medical Education and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM MISS
New PsA questionnaire fails to beat existing early screening methods
A new screening tool for detecting early psoriatic arthritis in patients with psoriasis that combined the “most discriminative questions” from several other questionnaires performed as well as the Psoriasis Epidemiology Screening Tool (PEST) for detecting the disease.
“The CONTEST questionnaire was developed using the best performing items from three other screening questionnaires in the hope that it would perform better than its originators,” Laura Coates, MBChB, PhD, of the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences at the University of Oxford, England, and her coauthors wrote in the Journal of the European Academy of Dermatology and Venereology. “In development this was partly correct but the current study does not support this – statistically there was no difference between PEST and CONTEST in terms of ability to detect psoriatic arthritis [PsA] in patients with psoriasis.”
The researchers found 27 patients (17%; 95% confidence interval, 12.3%-21.7%) with previously undiagnosed PsA, 71 with a different musculoskeletal disease, and 61 without musculoskeletal disease. Patients with PsA tended to be male, older, with “worse functional ability,” a similar age at onset of psoriasis, and had similar skin and nail disease severity. The sensitivity for PEST was 0.60 (95% CI, 0.42-0.78) and the specificity was 0.76 (95% CI, 0.69-0.83), while for CONTEST, the sensitivity was 0.53 (95% CI, 0.34-0.72) and the specificity was 0.71 (95% CI, 0.63-0.79). The area under the receiver operating curve confidence intervals for both screening tools were similar, with PEST having an AUC of 0.72 (95% CI, 0.61-0.84) and CONTEST having an AUC of 0.66 (95% CI, 0.54-0.77).
“The relative simplicity of the PEST questionnaire has raised concerns that the tool is not able to detect pure axial forms of the disease,” Dr. Coates and her colleagues wrote. “The CONTEST questionnaire includes items specific to back and neck pain, and so it was hoped it would better detect this subgroup. In this study this is not the case, although the numbers were small and imaging of the spine was not part of the study.”
AbbVie supported this study with an educational grant. The study was supported by the National Institute for Health Research Leeds Biomedical Research Centre. Some of the authors reported potential conflicts of interest.
SOURCE: Coates L et al. J Eur Acad Dermatol Venereol. 2018 Mar 26. doi: 10.1111/jdv.14971.
A new screening tool for detecting early psoriatic arthritis in patients with psoriasis that combined the “most discriminative questions” from several other questionnaires performed as well as the Psoriasis Epidemiology Screening Tool (PEST) for detecting the disease.
“The CONTEST questionnaire was developed using the best performing items from three other screening questionnaires in the hope that it would perform better than its originators,” Laura Coates, MBChB, PhD, of the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences at the University of Oxford, England, and her coauthors wrote in the Journal of the European Academy of Dermatology and Venereology. “In development this was partly correct but the current study does not support this – statistically there was no difference between PEST and CONTEST in terms of ability to detect psoriatic arthritis [PsA] in patients with psoriasis.”
The researchers found 27 patients (17%; 95% confidence interval, 12.3%-21.7%) with previously undiagnosed PsA, 71 with a different musculoskeletal disease, and 61 without musculoskeletal disease. Patients with PsA tended to be male, older, with “worse functional ability,” a similar age at onset of psoriasis, and had similar skin and nail disease severity. The sensitivity for PEST was 0.60 (95% CI, 0.42-0.78) and the specificity was 0.76 (95% CI, 0.69-0.83), while for CONTEST, the sensitivity was 0.53 (95% CI, 0.34-0.72) and the specificity was 0.71 (95% CI, 0.63-0.79). The area under the receiver operating curve confidence intervals for both screening tools were similar, with PEST having an AUC of 0.72 (95% CI, 0.61-0.84) and CONTEST having an AUC of 0.66 (95% CI, 0.54-0.77).
“The relative simplicity of the PEST questionnaire has raised concerns that the tool is not able to detect pure axial forms of the disease,” Dr. Coates and her colleagues wrote. “The CONTEST questionnaire includes items specific to back and neck pain, and so it was hoped it would better detect this subgroup. In this study this is not the case, although the numbers were small and imaging of the spine was not part of the study.”
AbbVie supported this study with an educational grant. The study was supported by the National Institute for Health Research Leeds Biomedical Research Centre. Some of the authors reported potential conflicts of interest.
SOURCE: Coates L et al. J Eur Acad Dermatol Venereol. 2018 Mar 26. doi: 10.1111/jdv.14971.
A new screening tool for detecting early psoriatic arthritis in patients with psoriasis that combined the “most discriminative questions” from several other questionnaires performed as well as the Psoriasis Epidemiology Screening Tool (PEST) for detecting the disease.
“The CONTEST questionnaire was developed using the best performing items from three other screening questionnaires in the hope that it would perform better than its originators,” Laura Coates, MBChB, PhD, of the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences at the University of Oxford, England, and her coauthors wrote in the Journal of the European Academy of Dermatology and Venereology. “In development this was partly correct but the current study does not support this – statistically there was no difference between PEST and CONTEST in terms of ability to detect psoriatic arthritis [PsA] in patients with psoriasis.”
The researchers found 27 patients (17%; 95% confidence interval, 12.3%-21.7%) with previously undiagnosed PsA, 71 with a different musculoskeletal disease, and 61 without musculoskeletal disease. Patients with PsA tended to be male, older, with “worse functional ability,” a similar age at onset of psoriasis, and had similar skin and nail disease severity. The sensitivity for PEST was 0.60 (95% CI, 0.42-0.78) and the specificity was 0.76 (95% CI, 0.69-0.83), while for CONTEST, the sensitivity was 0.53 (95% CI, 0.34-0.72) and the specificity was 0.71 (95% CI, 0.63-0.79). The area under the receiver operating curve confidence intervals for both screening tools were similar, with PEST having an AUC of 0.72 (95% CI, 0.61-0.84) and CONTEST having an AUC of 0.66 (95% CI, 0.54-0.77).
“The relative simplicity of the PEST questionnaire has raised concerns that the tool is not able to detect pure axial forms of the disease,” Dr. Coates and her colleagues wrote. “The CONTEST questionnaire includes items specific to back and neck pain, and so it was hoped it would better detect this subgroup. In this study this is not the case, although the numbers were small and imaging of the spine was not part of the study.”
AbbVie supported this study with an educational grant. The study was supported by the National Institute for Health Research Leeds Biomedical Research Centre. Some of the authors reported potential conflicts of interest.
SOURCE: Coates L et al. J Eur Acad Dermatol Venereol. 2018 Mar 26. doi: 10.1111/jdv.14971.
FROM JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY
Key clinical point: The CONTEST screening tool detected psoriatic arthritis in psoriasis patients as accurately as the Psoriasis Epidemiology Screening Tool.
Major finding: The sensitivity and specificity of CONTEST was 0.53 and 0.71, respectively, while PEST had a sensitivity of 0.60 and specificity of 0.76.
Study details: An observational, cross-sectional study of 159 psoriasis patients at four secondary care dermatology centers in the United Kingdom from November 2013 to March 2017.
Disclosures: AbbVie supported this study with an educational grant. The study was supported by the National Institute for Health Research Leeds Biomedical Research Centre. Some of the authors reported potential conflicts of interest.
Source: Coates L et al. J Eur Acad Dermatol Venereol. 2018 Mar 26. doi: 10.1111/jdv.14971.