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Study finds community-hospital lung cancer screening feasible
HOUSTON – Implementing a lung cancer screening program in a community hospital setting is feasible and saves lives, but implementation comes with its share of challenges, results from a single-center analysis demonstrated.
“Deaths from lung cancer surpass mortality of all other malignancies,” Simran Randhawa, MD, said during a press briefing at the annual meeting of the Society of Thoracic Surgeons. “The majority of lung cancers are found at an advanced stage, and the 5-year overall survival has only marginally improved over the past 40 years, and is approximately 17% according to recent data.
“Most people who die from lung cancer are former smokers,” said Dr. Randhawa, of the Einstein Healthcare Network, Philadelphia. “Former smokers cannot benefit from primary prevention, so this is where lung cancer screening comes into action.”
In 2011, the National Lung Screening Trial (NLST) showed a 20% relative reduction in lung cancer death with annual low-dose CT of the chest in high-risk patients. The reduction in mortality by any cause was by 6.7%.
“The number needed to be screened to prevent one death is 320, which may seem like a lot, but it is a very competitive number when compared to mammography or colonoscopy,” Dr. Randhawa said. “Lung cancer screening is also cost effective. It costs about $73,000 per quality adjusted life year, which can be further improved if offered with smoking cessation intervention.”
In October 2013, Einstein Healthcare Network offered a free lung cancer screening program. The purpose of the current study, which was led by Doraid Jarrar, MD, at the University of Pennsylvania, Philadelphia, was to evaluate the feasibility of establishing a lung cancer screening program in a community hospital system, to identify barriers to adoption, and to benchmark their experience with NLST results.
They promoted the screening program through flyers, radio programs, face-to-face information sessions, and a multidisciplinary lung symposium, prospectively collected data over 12 months, and decided patient eligibility based on NLST criteria. Results were reported using the Lung CT Screening Reporting and Data System (Lung-RADS).
Dr. Randhawa reported results from a total of 278 patients. Their average age was 64 years, 62% were female, 65% were African American, and the average number of pack years was 43.
Most (88%) were diagnosed with Lung-RADS 1 or 2 (negative or benign appearance), 7% were Lung-RADS 3 (probably benign but requiring close follow-up with CT scan), and 5% were Lung-RADS 4 (suspicious with a chance of malignancy).
Of the 11 patients who were diagnosed with Lung-RADS 4, 4 underwent lifesaving lung resection surgery for stage 1 disease, 1 patient was diagnosed with stage 4 disease, and the rest were either benign on follow-up or lost to follow-up.
“On further investigation, we found that 60% of the patients who showed up for the lung cancer screening were referred to us by their primary care physician, 22% had heard about our program through flyers as well as radio advertisements, 2% via Web search, and 1% through newsletters,” Dr. Randhawa said.
At the end of the study period, the researchers distributed a survey to all primary care and referring physicians. About 42% said they referred more than 10 patients in the last year, while 16% made no such referrals. When asked if they knew that lung cancer screening is recommended by the U.S. Preventive Services Task Force on par with mammography and colonoscopy, 74% said that they knew, but 26% indicated that they were not aware of that fact.
“When asked about any barriers they may have encountered, one physician commented on the lack of time to counsel his patients,” Dr. Randhawa said. “Most of the physicians expressed concerns about precertification [delays] and requirement for prior authorization for lung cancer screening.”
She acknowledged certain limitations of the study, including its small sample size and the fact that the researchers interviewed primary care physicians catering to an underserved population in the community, “which is not comparable to the NLST population,” she said.
“However, [our results] could be potentially more generalizable,” Dr. Randhawa noted. “In the future, we hope that there is evolving technology used for CT screening with reduction in radiation dose, and more accurate biomarkers will be developed to identify patients at highest risk for lung cancer. We aim to save lives through early detection of lung cancer with responsible CT lung screening.”
One of the study authors, Tracy Kane, MD, disclosed being a member of the speakers bureau for AstraZeneca and receiving honoraria from the company. The other researchers reported having no financial disclosures.
HOUSTON – Implementing a lung cancer screening program in a community hospital setting is feasible and saves lives, but implementation comes with its share of challenges, results from a single-center analysis demonstrated.
“Deaths from lung cancer surpass mortality of all other malignancies,” Simran Randhawa, MD, said during a press briefing at the annual meeting of the Society of Thoracic Surgeons. “The majority of lung cancers are found at an advanced stage, and the 5-year overall survival has only marginally improved over the past 40 years, and is approximately 17% according to recent data.
“Most people who die from lung cancer are former smokers,” said Dr. Randhawa, of the Einstein Healthcare Network, Philadelphia. “Former smokers cannot benefit from primary prevention, so this is where lung cancer screening comes into action.”
In 2011, the National Lung Screening Trial (NLST) showed a 20% relative reduction in lung cancer death with annual low-dose CT of the chest in high-risk patients. The reduction in mortality by any cause was by 6.7%.
“The number needed to be screened to prevent one death is 320, which may seem like a lot, but it is a very competitive number when compared to mammography or colonoscopy,” Dr. Randhawa said. “Lung cancer screening is also cost effective. It costs about $73,000 per quality adjusted life year, which can be further improved if offered with smoking cessation intervention.”
In October 2013, Einstein Healthcare Network offered a free lung cancer screening program. The purpose of the current study, which was led by Doraid Jarrar, MD, at the University of Pennsylvania, Philadelphia, was to evaluate the feasibility of establishing a lung cancer screening program in a community hospital system, to identify barriers to adoption, and to benchmark their experience with NLST results.
They promoted the screening program through flyers, radio programs, face-to-face information sessions, and a multidisciplinary lung symposium, prospectively collected data over 12 months, and decided patient eligibility based on NLST criteria. Results were reported using the Lung CT Screening Reporting and Data System (Lung-RADS).
Dr. Randhawa reported results from a total of 278 patients. Their average age was 64 years, 62% were female, 65% were African American, and the average number of pack years was 43.
Most (88%) were diagnosed with Lung-RADS 1 or 2 (negative or benign appearance), 7% were Lung-RADS 3 (probably benign but requiring close follow-up with CT scan), and 5% were Lung-RADS 4 (suspicious with a chance of malignancy).
Of the 11 patients who were diagnosed with Lung-RADS 4, 4 underwent lifesaving lung resection surgery for stage 1 disease, 1 patient was diagnosed with stage 4 disease, and the rest were either benign on follow-up or lost to follow-up.
“On further investigation, we found that 60% of the patients who showed up for the lung cancer screening were referred to us by their primary care physician, 22% had heard about our program through flyers as well as radio advertisements, 2% via Web search, and 1% through newsletters,” Dr. Randhawa said.
At the end of the study period, the researchers distributed a survey to all primary care and referring physicians. About 42% said they referred more than 10 patients in the last year, while 16% made no such referrals. When asked if they knew that lung cancer screening is recommended by the U.S. Preventive Services Task Force on par with mammography and colonoscopy, 74% said that they knew, but 26% indicated that they were not aware of that fact.
“When asked about any barriers they may have encountered, one physician commented on the lack of time to counsel his patients,” Dr. Randhawa said. “Most of the physicians expressed concerns about precertification [delays] and requirement for prior authorization for lung cancer screening.”
She acknowledged certain limitations of the study, including its small sample size and the fact that the researchers interviewed primary care physicians catering to an underserved population in the community, “which is not comparable to the NLST population,” she said.
“However, [our results] could be potentially more generalizable,” Dr. Randhawa noted. “In the future, we hope that there is evolving technology used for CT screening with reduction in radiation dose, and more accurate biomarkers will be developed to identify patients at highest risk for lung cancer. We aim to save lives through early detection of lung cancer with responsible CT lung screening.”
One of the study authors, Tracy Kane, MD, disclosed being a member of the speakers bureau for AstraZeneca and receiving honoraria from the company. The other researchers reported having no financial disclosures.
HOUSTON – Implementing a lung cancer screening program in a community hospital setting is feasible and saves lives, but implementation comes with its share of challenges, results from a single-center analysis demonstrated.
“Deaths from lung cancer surpass mortality of all other malignancies,” Simran Randhawa, MD, said during a press briefing at the annual meeting of the Society of Thoracic Surgeons. “The majority of lung cancers are found at an advanced stage, and the 5-year overall survival has only marginally improved over the past 40 years, and is approximately 17% according to recent data.
“Most people who die from lung cancer are former smokers,” said Dr. Randhawa, of the Einstein Healthcare Network, Philadelphia. “Former smokers cannot benefit from primary prevention, so this is where lung cancer screening comes into action.”
In 2011, the National Lung Screening Trial (NLST) showed a 20% relative reduction in lung cancer death with annual low-dose CT of the chest in high-risk patients. The reduction in mortality by any cause was by 6.7%.
“The number needed to be screened to prevent one death is 320, which may seem like a lot, but it is a very competitive number when compared to mammography or colonoscopy,” Dr. Randhawa said. “Lung cancer screening is also cost effective. It costs about $73,000 per quality adjusted life year, which can be further improved if offered with smoking cessation intervention.”
In October 2013, Einstein Healthcare Network offered a free lung cancer screening program. The purpose of the current study, which was led by Doraid Jarrar, MD, at the University of Pennsylvania, Philadelphia, was to evaluate the feasibility of establishing a lung cancer screening program in a community hospital system, to identify barriers to adoption, and to benchmark their experience with NLST results.
They promoted the screening program through flyers, radio programs, face-to-face information sessions, and a multidisciplinary lung symposium, prospectively collected data over 12 months, and decided patient eligibility based on NLST criteria. Results were reported using the Lung CT Screening Reporting and Data System (Lung-RADS).
Dr. Randhawa reported results from a total of 278 patients. Their average age was 64 years, 62% were female, 65% were African American, and the average number of pack years was 43.
Most (88%) were diagnosed with Lung-RADS 1 or 2 (negative or benign appearance), 7% were Lung-RADS 3 (probably benign but requiring close follow-up with CT scan), and 5% were Lung-RADS 4 (suspicious with a chance of malignancy).
Of the 11 patients who were diagnosed with Lung-RADS 4, 4 underwent lifesaving lung resection surgery for stage 1 disease, 1 patient was diagnosed with stage 4 disease, and the rest were either benign on follow-up or lost to follow-up.
“On further investigation, we found that 60% of the patients who showed up for the lung cancer screening were referred to us by their primary care physician, 22% had heard about our program through flyers as well as radio advertisements, 2% via Web search, and 1% through newsletters,” Dr. Randhawa said.
At the end of the study period, the researchers distributed a survey to all primary care and referring physicians. About 42% said they referred more than 10 patients in the last year, while 16% made no such referrals. When asked if they knew that lung cancer screening is recommended by the U.S. Preventive Services Task Force on par with mammography and colonoscopy, 74% said that they knew, but 26% indicated that they were not aware of that fact.
“When asked about any barriers they may have encountered, one physician commented on the lack of time to counsel his patients,” Dr. Randhawa said. “Most of the physicians expressed concerns about precertification [delays] and requirement for prior authorization for lung cancer screening.”
She acknowledged certain limitations of the study, including its small sample size and the fact that the researchers interviewed primary care physicians catering to an underserved population in the community, “which is not comparable to the NLST population,” she said.
“However, [our results] could be potentially more generalizable,” Dr. Randhawa noted. “In the future, we hope that there is evolving technology used for CT screening with reduction in radiation dose, and more accurate biomarkers will be developed to identify patients at highest risk for lung cancer. We aim to save lives through early detection of lung cancer with responsible CT lung screening.”
One of the study authors, Tracy Kane, MD, disclosed being a member of the speakers bureau for AstraZeneca and receiving honoraria from the company. The other researchers reported having no financial disclosures.
Key clinical point:
Major finding: Of patients who participated in a community screening program over the course of 1 year, 88% were diagnosed with Lung-RADS 1 or 2, 7% were Lung-RADS 3, and 5% were Lung-RADS 4.
Data source: A 12-month prospective study of 278 patients at risk for lung cancer.
Disclosures: One of the study authors, Tracy Kane, MD, disclosed being a member of the speakers bureau for AstraZeneca and receiving honoraria from the company. The other researchers reported having no financial disclosures.
VIDEO: Public reporting of congenital heart disease outcomes should be easily understood
HOUSTON – Survival statistics, surgeon-specific experience, and complication rates are the types of information most sought by parents of children with congenital heart disease, results from a large survey suggest.
Future efforts in public reporting for congenital heart surgery outcomes should have better methods for presenting the data in a valid, easily interpreted format, explained study investigator Mallory L. Irons, MD, an integrated cardiac surgery resident at the Hospital of the University of Pennsylvania, Philadelphia.
“We’re doing a good job of public reporting currently, but what we’re doing is not meeting the needs of all of our stakeholders – in this case, the parents of children with congenital heart disease,” Dr. Irons said in an interview at the annual meeting of the Society of Thoracic Surgeons. “The optimal public reporting scheme still has yet to be determined.”
Dr. Irons reported having no financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
HOUSTON – Survival statistics, surgeon-specific experience, and complication rates are the types of information most sought by parents of children with congenital heart disease, results from a large survey suggest.
Future efforts in public reporting for congenital heart surgery outcomes should have better methods for presenting the data in a valid, easily interpreted format, explained study investigator Mallory L. Irons, MD, an integrated cardiac surgery resident at the Hospital of the University of Pennsylvania, Philadelphia.
“We’re doing a good job of public reporting currently, but what we’re doing is not meeting the needs of all of our stakeholders – in this case, the parents of children with congenital heart disease,” Dr. Irons said in an interview at the annual meeting of the Society of Thoracic Surgeons. “The optimal public reporting scheme still has yet to be determined.”
Dr. Irons reported having no financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
HOUSTON – Survival statistics, surgeon-specific experience, and complication rates are the types of information most sought by parents of children with congenital heart disease, results from a large survey suggest.
Future efforts in public reporting for congenital heart surgery outcomes should have better methods for presenting the data in a valid, easily interpreted format, explained study investigator Mallory L. Irons, MD, an integrated cardiac surgery resident at the Hospital of the University of Pennsylvania, Philadelphia.
“We’re doing a good job of public reporting currently, but what we’re doing is not meeting the needs of all of our stakeholders – in this case, the parents of children with congenital heart disease,” Dr. Irons said in an interview at the annual meeting of the Society of Thoracic Surgeons. “The optimal public reporting scheme still has yet to be determined.”
Dr. Irons reported having no financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
FROM THE STS ANNUAL MEETING HOUSTON
Our new year’s resolutions
Be at war with your vices, at peace with your neighbors, and let every new year find you a better person.
– Benjamin Franklin
Traditionally, the new year is a time for reflection, looking back to review what could have been done better, and looking forward to the opportunity to rectify those inadequacies over the coming year. We thought we would take this opportunity to look at our use of the electronic health record and think about the things we might do over the next year to make our lives easier and our charting better.
Top of our list is a renewed commitment to finish our notes by the end of each session. Too many physicians we know rush through patient hours and then are left with 10-20 notes to finish at the end of the day. Realistically, this is when we least feel like completing notes. Such work encroaches on personal and family time, likely contributes to the burnout that has been increasing among physicians, and is much less likely to accurately represent the encounter than notes completed in real time.
As we have spoken with many of our colleagues, it has become clear to us that many clinicians have learned how to be “just proficient enough” in their use of their EHR; they are not pulling out their hair every 5 minutes in frustration, but they have not taken the extra time and effort that are needed to optimize their productivity. To efficiently use an EHR requires some time spent designing templates and macros to make it easy to repetitively carry out common tasks.
A lot of physicians – particularly physicians over 40 years of age – are still typing their notes with the ol’ two-finger hunt-and-peck technique. This is incredibly time consuming, inefficient, and frustrating.
While many solutions have been proposed, including having a scribe walk around with the doctor, the simplest and easiest to implement is voice transcription. Even though medical transcription software is expensive, the return on investment is large for those who do not type well. After a short period of training on the software, notes are generally of higher quality and are finished considerably faster than when typing. The technology also has the ability to learn the names of frequently used consultants, medications, and procedures, so users don’t even have to type uncommon names or words.
Another area in which we hope to advance over the next year is working more effectively as a team to share the documentation burden. Nurses and medical assistants – within the boundaries of their licensing – can be empowered to document in predefined areas of the chart as much as possible.
For example, given the fact that the prevalence of depression is about twice as high in patients with diabetes as it is in the general population, our medical assistants now screen our diabetes patients with a PHQ-2 depression screen and record the results in the chart. This has been good for our patients, satisfying for our medical assistants, and has offloaded this task from the doctors.
We need to think of more areas where we can facilitate team care and really make everyone – physicians, nurses, front staff, and patients – more satisfied with the care that is being given.
Most EHRs have a reminder function – the ability to prompt a user to follow up on an abnormal x-ray or lab results in case a patient does not come back into the office as recommended. Our sense is that most of us are not using this function. It is worth finding out how to use it and giving it a try.
Patient portals have gained a lot of traction over the past few years. For a little while, we were really making an effort to have patients register, so that currently many (but by far not most) of our patients have signed up. We want to make better use of this fantastic resource.
We say “fantastic” because when we talk to patients (or friends or family) who use the portal, they have shared that it really makes their lives easier. They are able to see their labs, ponder the meaning of their results (perhaps of a slightly high glucose or an LDL cholesterol level), and if they have questions, they can correspond electronically with their care providers. It enhances care and allows us to spend less time on the phone, while giving patients better access to information.
New year’s resolutions are an opportunity for reflection and optimism. As we look back on the past year, we should learn from our experience and approach the year in front of us with greater enthusiasm, in the hope that through that enthusiasm we can continue to grow, be better and healthier, and simply be more like the people we want to be.
The electronic health record affects all of our interactions with patients and colleagues, and, when not used optimally, encroaches into our personal and family lives. It is a perfect place to focus during the new year to enable us to have more productive, effective, and happier times both in the office and at home.
Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is associate director of the family medicine residency program at Abington Memorial Hospital and professor of family and community medicine at Temple University in Philadelphia.
Be at war with your vices, at peace with your neighbors, and let every new year find you a better person.
– Benjamin Franklin
Traditionally, the new year is a time for reflection, looking back to review what could have been done better, and looking forward to the opportunity to rectify those inadequacies over the coming year. We thought we would take this opportunity to look at our use of the electronic health record and think about the things we might do over the next year to make our lives easier and our charting better.
Top of our list is a renewed commitment to finish our notes by the end of each session. Too many physicians we know rush through patient hours and then are left with 10-20 notes to finish at the end of the day. Realistically, this is when we least feel like completing notes. Such work encroaches on personal and family time, likely contributes to the burnout that has been increasing among physicians, and is much less likely to accurately represent the encounter than notes completed in real time.
As we have spoken with many of our colleagues, it has become clear to us that many clinicians have learned how to be “just proficient enough” in their use of their EHR; they are not pulling out their hair every 5 minutes in frustration, but they have not taken the extra time and effort that are needed to optimize their productivity. To efficiently use an EHR requires some time spent designing templates and macros to make it easy to repetitively carry out common tasks.
A lot of physicians – particularly physicians over 40 years of age – are still typing their notes with the ol’ two-finger hunt-and-peck technique. This is incredibly time consuming, inefficient, and frustrating.
While many solutions have been proposed, including having a scribe walk around with the doctor, the simplest and easiest to implement is voice transcription. Even though medical transcription software is expensive, the return on investment is large for those who do not type well. After a short period of training on the software, notes are generally of higher quality and are finished considerably faster than when typing. The technology also has the ability to learn the names of frequently used consultants, medications, and procedures, so users don’t even have to type uncommon names or words.
Another area in which we hope to advance over the next year is working more effectively as a team to share the documentation burden. Nurses and medical assistants – within the boundaries of their licensing – can be empowered to document in predefined areas of the chart as much as possible.
For example, given the fact that the prevalence of depression is about twice as high in patients with diabetes as it is in the general population, our medical assistants now screen our diabetes patients with a PHQ-2 depression screen and record the results in the chart. This has been good for our patients, satisfying for our medical assistants, and has offloaded this task from the doctors.
We need to think of more areas where we can facilitate team care and really make everyone – physicians, nurses, front staff, and patients – more satisfied with the care that is being given.
Most EHRs have a reminder function – the ability to prompt a user to follow up on an abnormal x-ray or lab results in case a patient does not come back into the office as recommended. Our sense is that most of us are not using this function. It is worth finding out how to use it and giving it a try.
Patient portals have gained a lot of traction over the past few years. For a little while, we were really making an effort to have patients register, so that currently many (but by far not most) of our patients have signed up. We want to make better use of this fantastic resource.
We say “fantastic” because when we talk to patients (or friends or family) who use the portal, they have shared that it really makes their lives easier. They are able to see their labs, ponder the meaning of their results (perhaps of a slightly high glucose or an LDL cholesterol level), and if they have questions, they can correspond electronically with their care providers. It enhances care and allows us to spend less time on the phone, while giving patients better access to information.
New year’s resolutions are an opportunity for reflection and optimism. As we look back on the past year, we should learn from our experience and approach the year in front of us with greater enthusiasm, in the hope that through that enthusiasm we can continue to grow, be better and healthier, and simply be more like the people we want to be.
The electronic health record affects all of our interactions with patients and colleagues, and, when not used optimally, encroaches into our personal and family lives. It is a perfect place to focus during the new year to enable us to have more productive, effective, and happier times both in the office and at home.
Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is associate director of the family medicine residency program at Abington Memorial Hospital and professor of family and community medicine at Temple University in Philadelphia.
Be at war with your vices, at peace with your neighbors, and let every new year find you a better person.
– Benjamin Franklin
Traditionally, the new year is a time for reflection, looking back to review what could have been done better, and looking forward to the opportunity to rectify those inadequacies over the coming year. We thought we would take this opportunity to look at our use of the electronic health record and think about the things we might do over the next year to make our lives easier and our charting better.
Top of our list is a renewed commitment to finish our notes by the end of each session. Too many physicians we know rush through patient hours and then are left with 10-20 notes to finish at the end of the day. Realistically, this is when we least feel like completing notes. Such work encroaches on personal and family time, likely contributes to the burnout that has been increasing among physicians, and is much less likely to accurately represent the encounter than notes completed in real time.
As we have spoken with many of our colleagues, it has become clear to us that many clinicians have learned how to be “just proficient enough” in their use of their EHR; they are not pulling out their hair every 5 minutes in frustration, but they have not taken the extra time and effort that are needed to optimize their productivity. To efficiently use an EHR requires some time spent designing templates and macros to make it easy to repetitively carry out common tasks.
A lot of physicians – particularly physicians over 40 years of age – are still typing their notes with the ol’ two-finger hunt-and-peck technique. This is incredibly time consuming, inefficient, and frustrating.
While many solutions have been proposed, including having a scribe walk around with the doctor, the simplest and easiest to implement is voice transcription. Even though medical transcription software is expensive, the return on investment is large for those who do not type well. After a short period of training on the software, notes are generally of higher quality and are finished considerably faster than when typing. The technology also has the ability to learn the names of frequently used consultants, medications, and procedures, so users don’t even have to type uncommon names or words.
Another area in which we hope to advance over the next year is working more effectively as a team to share the documentation burden. Nurses and medical assistants – within the boundaries of their licensing – can be empowered to document in predefined areas of the chart as much as possible.
For example, given the fact that the prevalence of depression is about twice as high in patients with diabetes as it is in the general population, our medical assistants now screen our diabetes patients with a PHQ-2 depression screen and record the results in the chart. This has been good for our patients, satisfying for our medical assistants, and has offloaded this task from the doctors.
We need to think of more areas where we can facilitate team care and really make everyone – physicians, nurses, front staff, and patients – more satisfied with the care that is being given.
Most EHRs have a reminder function – the ability to prompt a user to follow up on an abnormal x-ray or lab results in case a patient does not come back into the office as recommended. Our sense is that most of us are not using this function. It is worth finding out how to use it and giving it a try.
Patient portals have gained a lot of traction over the past few years. For a little while, we were really making an effort to have patients register, so that currently many (but by far not most) of our patients have signed up. We want to make better use of this fantastic resource.
We say “fantastic” because when we talk to patients (or friends or family) who use the portal, they have shared that it really makes their lives easier. They are able to see their labs, ponder the meaning of their results (perhaps of a slightly high glucose or an LDL cholesterol level), and if they have questions, they can correspond electronically with their care providers. It enhances care and allows us to spend less time on the phone, while giving patients better access to information.
New year’s resolutions are an opportunity for reflection and optimism. As we look back on the past year, we should learn from our experience and approach the year in front of us with greater enthusiasm, in the hope that through that enthusiasm we can continue to grow, be better and healthier, and simply be more like the people we want to be.
The electronic health record affects all of our interactions with patients and colleagues, and, when not used optimally, encroaches into our personal and family lives. It is a perfect place to focus during the new year to enable us to have more productive, effective, and happier times both in the office and at home.
Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is associate director of the family medicine residency program at Abington Memorial Hospital and professor of family and community medicine at Temple University in Philadelphia.
Bortezomib-based regimen led to durable remissions in mantle cell lymphoma
SAN DIEGO – For adults with mantle cell lymphoma, adding bortezomib to a modified hyper-CVAD (VcR-CVAD) regimen followed by rituximab maintenance induced durable remissions at rates resembling those seen with more intensive chemotherapy followed by autologous hematopoietic stem cell transplantation, according to long-term results from a multicenter phase II trial.
Two-thirds of patients were alive and 50% remained in remission after a median follow-up period of 7.8 years, said Julie E. Chang, MD, who reported the results of the study at the annual meeting of the American Society of Hematology. “VcR-CVAD is a moderate-intensity chemotherapy regimen that is tolerable for many older and less fit adult patients as first-line therapy of mantle cell lymphoma,” she emphasized.
Mantle cell lymphoma lacks a clear standard first-line therapy, noted Dr. Chang of the University of Wisconsin in Madison. “We hypothesized that the addition of bortezomib would improve the complete response rate, and maintenance rituximab would improve the remission duration,” she said.
To test that idea, she and her associates enrolled 30 adults with histologically confirmed mantle cell lymphoma who had received either no treatment or just one cycle of CHOP or CHOP-like chemotherapy.
Patients received six 21-day cycles of VcR-CVAD induction chemotherapy. This regimen consisted of rituximab (375 mg/m2 IV) on day 1; bortezomib (1.3 mg/m2 IV) on days 1 and 4; cyclophosphamide (300 mg/m2 IV every 12 hours) on days 1 through 3; doxorubicin (50 mg/m2 IV given as a continuous infusion) on days 1 and 2; vincristine (1 mg IV) on day 3; and dexamethasone (40 mg orally) on days 1 through 4.
Patients were permitted all supportive care measures, including prophylaxis for tumor lysis syndrome, transfusions, and antibiotics. Those with at least a partial response received rituximab consolidation (375 mg/m2 IV per week for 4 weeks) followed by rituximab maintenance (375 mg/m2 IV every 12 weeks for 5 years).
Median age was 61 years (range, 48-74 years), 80% of patients were male, all had advanced-stage disease, 60% were mantle cell lymphoma international prognostic index (MIPI) medium or high risk, and six had blastic morphology, the researchers noted.
Estimated 6-year rates of progression-free and overall survival were 53% (95% confidence interval, 38%-75%) and 70% (95% CI, 55%-84%), respectively. Neither age nor MIPI score significantly affected the chances of progression-free or overall survival, but there was a trend toward worse survival among MIPI high-risk patients.
The 10 deaths included 5 from progressive disease, 3 from complications after allogeneic transplant, and 2 from unrelated causes. No patients who remained progression free for 5 years subsequently relapsed, nor were there late toxicities related to treatment.
A recent phase III trial (N Engl J Med. 2015 Mar 5;372[10]:944-53) confirmed the benefits of adding bortezomib to standard immunochemotherapy in mantle cell lymphoma, Dr. Chang noted. “VcR-CVAD remains an effective therapy choice for initial treatment of MCL, both in younger and older MCL populations,” she concluded.
Dr. Chang had no relevant disclosures. Senior author Brad S. Kahl, MD, disclosed ties to Celgene, Gilead, Infinity, Juno, Pharmacyclics, and Seattle Genetics.
SAN DIEGO – For adults with mantle cell lymphoma, adding bortezomib to a modified hyper-CVAD (VcR-CVAD) regimen followed by rituximab maintenance induced durable remissions at rates resembling those seen with more intensive chemotherapy followed by autologous hematopoietic stem cell transplantation, according to long-term results from a multicenter phase II trial.
Two-thirds of patients were alive and 50% remained in remission after a median follow-up period of 7.8 years, said Julie E. Chang, MD, who reported the results of the study at the annual meeting of the American Society of Hematology. “VcR-CVAD is a moderate-intensity chemotherapy regimen that is tolerable for many older and less fit adult patients as first-line therapy of mantle cell lymphoma,” she emphasized.
Mantle cell lymphoma lacks a clear standard first-line therapy, noted Dr. Chang of the University of Wisconsin in Madison. “We hypothesized that the addition of bortezomib would improve the complete response rate, and maintenance rituximab would improve the remission duration,” she said.
To test that idea, she and her associates enrolled 30 adults with histologically confirmed mantle cell lymphoma who had received either no treatment or just one cycle of CHOP or CHOP-like chemotherapy.
Patients received six 21-day cycles of VcR-CVAD induction chemotherapy. This regimen consisted of rituximab (375 mg/m2 IV) on day 1; bortezomib (1.3 mg/m2 IV) on days 1 and 4; cyclophosphamide (300 mg/m2 IV every 12 hours) on days 1 through 3; doxorubicin (50 mg/m2 IV given as a continuous infusion) on days 1 and 2; vincristine (1 mg IV) on day 3; and dexamethasone (40 mg orally) on days 1 through 4.
Patients were permitted all supportive care measures, including prophylaxis for tumor lysis syndrome, transfusions, and antibiotics. Those with at least a partial response received rituximab consolidation (375 mg/m2 IV per week for 4 weeks) followed by rituximab maintenance (375 mg/m2 IV every 12 weeks for 5 years).
Median age was 61 years (range, 48-74 years), 80% of patients were male, all had advanced-stage disease, 60% were mantle cell lymphoma international prognostic index (MIPI) medium or high risk, and six had blastic morphology, the researchers noted.
Estimated 6-year rates of progression-free and overall survival were 53% (95% confidence interval, 38%-75%) and 70% (95% CI, 55%-84%), respectively. Neither age nor MIPI score significantly affected the chances of progression-free or overall survival, but there was a trend toward worse survival among MIPI high-risk patients.
The 10 deaths included 5 from progressive disease, 3 from complications after allogeneic transplant, and 2 from unrelated causes. No patients who remained progression free for 5 years subsequently relapsed, nor were there late toxicities related to treatment.
A recent phase III trial (N Engl J Med. 2015 Mar 5;372[10]:944-53) confirmed the benefits of adding bortezomib to standard immunochemotherapy in mantle cell lymphoma, Dr. Chang noted. “VcR-CVAD remains an effective therapy choice for initial treatment of MCL, both in younger and older MCL populations,” she concluded.
Dr. Chang had no relevant disclosures. Senior author Brad S. Kahl, MD, disclosed ties to Celgene, Gilead, Infinity, Juno, Pharmacyclics, and Seattle Genetics.
SAN DIEGO – For adults with mantle cell lymphoma, adding bortezomib to a modified hyper-CVAD (VcR-CVAD) regimen followed by rituximab maintenance induced durable remissions at rates resembling those seen with more intensive chemotherapy followed by autologous hematopoietic stem cell transplantation, according to long-term results from a multicenter phase II trial.
Two-thirds of patients were alive and 50% remained in remission after a median follow-up period of 7.8 years, said Julie E. Chang, MD, who reported the results of the study at the annual meeting of the American Society of Hematology. “VcR-CVAD is a moderate-intensity chemotherapy regimen that is tolerable for many older and less fit adult patients as first-line therapy of mantle cell lymphoma,” she emphasized.
Mantle cell lymphoma lacks a clear standard first-line therapy, noted Dr. Chang of the University of Wisconsin in Madison. “We hypothesized that the addition of bortezomib would improve the complete response rate, and maintenance rituximab would improve the remission duration,” she said.
To test that idea, she and her associates enrolled 30 adults with histologically confirmed mantle cell lymphoma who had received either no treatment or just one cycle of CHOP or CHOP-like chemotherapy.
Patients received six 21-day cycles of VcR-CVAD induction chemotherapy. This regimen consisted of rituximab (375 mg/m2 IV) on day 1; bortezomib (1.3 mg/m2 IV) on days 1 and 4; cyclophosphamide (300 mg/m2 IV every 12 hours) on days 1 through 3; doxorubicin (50 mg/m2 IV given as a continuous infusion) on days 1 and 2; vincristine (1 mg IV) on day 3; and dexamethasone (40 mg orally) on days 1 through 4.
Patients were permitted all supportive care measures, including prophylaxis for tumor lysis syndrome, transfusions, and antibiotics. Those with at least a partial response received rituximab consolidation (375 mg/m2 IV per week for 4 weeks) followed by rituximab maintenance (375 mg/m2 IV every 12 weeks for 5 years).
Median age was 61 years (range, 48-74 years), 80% of patients were male, all had advanced-stage disease, 60% were mantle cell lymphoma international prognostic index (MIPI) medium or high risk, and six had blastic morphology, the researchers noted.
Estimated 6-year rates of progression-free and overall survival were 53% (95% confidence interval, 38%-75%) and 70% (95% CI, 55%-84%), respectively. Neither age nor MIPI score significantly affected the chances of progression-free or overall survival, but there was a trend toward worse survival among MIPI high-risk patients.
The 10 deaths included 5 from progressive disease, 3 from complications after allogeneic transplant, and 2 from unrelated causes. No patients who remained progression free for 5 years subsequently relapsed, nor were there late toxicities related to treatment.
A recent phase III trial (N Engl J Med. 2015 Mar 5;372[10]:944-53) confirmed the benefits of adding bortezomib to standard immunochemotherapy in mantle cell lymphoma, Dr. Chang noted. “VcR-CVAD remains an effective therapy choice for initial treatment of MCL, both in younger and older MCL populations,” she concluded.
Dr. Chang had no relevant disclosures. Senior author Brad S. Kahl, MD, disclosed ties to Celgene, Gilead, Infinity, Juno, Pharmacyclics, and Seattle Genetics.
Key clinical point: First-line therapy with bortezomib plus modified hyper-CVAD followed by rituximab maintenance induced durable remissions in mantle cell lymphoma.
Major finding: Two-thirds of patients were alive and 50% remained in remission after a median follow-up period of 7.8 years.
Data source: A multicenter phase II trial of 30 adults with mantle cell lymphoma who were treatment-naïve or had received only one cycle of CHOP or CHOP-like chemotherapy.
Disclosures: Dr. Chang had no relevant disclosures. Senior author Brad S. Kahl, MD, disclosed ties to Celgene, Gilead, Infinity, Juno, Pharmacyclics, and Seattle Genetics.
Model: Quadrivalent vaccine could cost effectively cut MSM’s HPV-related cancers
Use of a quadrivalent HPV vaccine in men who have sex with men, administered in genitourinary specialty clinics, would cost effectively provide herd immunity against the ill effects of the virus, particularly anogenital warts and male HPV-related cancers, according to an English mathematical model.
Mark Jit, PhD, a professor of vaccine epidemiology at the London School of Hygiene & Tropical Medicine, and his colleagues considered in which settings HPV vaccination delivery would have the greatest effect size; the patterns of sexual behavior in MSM leading to the transmission of HPV 6, 11, 16, and 18; and the costs and quality adjusted life year (QALY) implications of disease outcomes (Clin Infect Dis. 2016 Dec 23. doi: 10.1093/cid/ciw845).
Clinic attendance rates were based on genitourinary clinic returns in England recorded in public health surveillance data recorded between 2009 and 2012, stratified according to diagnosed HIV-positive status. Also modeled were the effects of vaccination in MSM between the ages of 16 and 40 years, according to groups aged 16-25 years, 16-30 years, 16-35 years, and 16-40 years. Models for ages on either side of 16 or 40 years were not considered because of confidentiality constraints in the former and limited specialty clinic use in the latter.
Herd protection likely would be notable in the first year, because of the breadth of the age ranges modeled, Dr. Jit and his colleagues determined. Specifically, the models predicted a 35% decline in incidence rates of anogenital warts within 5 years of initiating the vaccine across all MSM men seen in specialty clinics. If only HIV-positive MSM across the age groups were vaccinated, the models predicted a 5-year decline of 15%.
Declines predicted in HPV-related cancers would happen more slowly, because progression from infection to malignancies tends to occur over years. For example, there would be a 55% reduction over 100 years for anal cancer if all 16- to 40-year-old MSM attending specialty clinics are offered vaccination. However, the reduction rate would drop to 40% in that same time period if only HIV-positive men across the age groups were vaccinated.
Using a cost-effectiveness threshold of 20,000 British pounds (about $24,500) per QALY, with no more than a 10% probability that the incremental cost-effectiveness ratio would exceed 30,000 pounds per QALY ($36,710), Dr. Jit and his colleagues determined that using a quadrivalent HPV vaccination in MSM between ages 16 and 40 years in the specialty clinic setting would be cost effective if delivery cost an average of 63 pounds ($77) per dose.
By offering vaccination only to HIV-positive MSM between 16 and 40 years, even if the quadrivalent vaccine were to cost as much as 96.50 pounds ($118), it would still be cost effective. A nonavalent vaccine at the same price would also be cost effective, because nearly all HPV-related cancers are linked to HPV 16 and 18. However, a bivalent vaccine was not shown by the models to be cost effective in such a limited program.
The investigators theorized that HIV infection is associated with the rate of HPV-related disease progression. To simplify computation, however, their models only considered the overall cost effectiveness of offering HPV vaccination to either HIV-positive MSM or to MSM regardless of current HIV status. That could mean “the cost effectiveness of MSM vaccination may be even better than reported,” the researchers noted.
This study was funded primarily by the National Institute for Health Research and Public Health England in the United Kingdom. The authors had no relevant disclosures.
[email protected]On Twitter @whitneymcknight
Use of a quadrivalent HPV vaccine in men who have sex with men, administered in genitourinary specialty clinics, would cost effectively provide herd immunity against the ill effects of the virus, particularly anogenital warts and male HPV-related cancers, according to an English mathematical model.
Mark Jit, PhD, a professor of vaccine epidemiology at the London School of Hygiene & Tropical Medicine, and his colleagues considered in which settings HPV vaccination delivery would have the greatest effect size; the patterns of sexual behavior in MSM leading to the transmission of HPV 6, 11, 16, and 18; and the costs and quality adjusted life year (QALY) implications of disease outcomes (Clin Infect Dis. 2016 Dec 23. doi: 10.1093/cid/ciw845).
Clinic attendance rates were based on genitourinary clinic returns in England recorded in public health surveillance data recorded between 2009 and 2012, stratified according to diagnosed HIV-positive status. Also modeled were the effects of vaccination in MSM between the ages of 16 and 40 years, according to groups aged 16-25 years, 16-30 years, 16-35 years, and 16-40 years. Models for ages on either side of 16 or 40 years were not considered because of confidentiality constraints in the former and limited specialty clinic use in the latter.
Herd protection likely would be notable in the first year, because of the breadth of the age ranges modeled, Dr. Jit and his colleagues determined. Specifically, the models predicted a 35% decline in incidence rates of anogenital warts within 5 years of initiating the vaccine across all MSM men seen in specialty clinics. If only HIV-positive MSM across the age groups were vaccinated, the models predicted a 5-year decline of 15%.
Declines predicted in HPV-related cancers would happen more slowly, because progression from infection to malignancies tends to occur over years. For example, there would be a 55% reduction over 100 years for anal cancer if all 16- to 40-year-old MSM attending specialty clinics are offered vaccination. However, the reduction rate would drop to 40% in that same time period if only HIV-positive men across the age groups were vaccinated.
Using a cost-effectiveness threshold of 20,000 British pounds (about $24,500) per QALY, with no more than a 10% probability that the incremental cost-effectiveness ratio would exceed 30,000 pounds per QALY ($36,710), Dr. Jit and his colleagues determined that using a quadrivalent HPV vaccination in MSM between ages 16 and 40 years in the specialty clinic setting would be cost effective if delivery cost an average of 63 pounds ($77) per dose.
By offering vaccination only to HIV-positive MSM between 16 and 40 years, even if the quadrivalent vaccine were to cost as much as 96.50 pounds ($118), it would still be cost effective. A nonavalent vaccine at the same price would also be cost effective, because nearly all HPV-related cancers are linked to HPV 16 and 18. However, a bivalent vaccine was not shown by the models to be cost effective in such a limited program.
The investigators theorized that HIV infection is associated with the rate of HPV-related disease progression. To simplify computation, however, their models only considered the overall cost effectiveness of offering HPV vaccination to either HIV-positive MSM or to MSM regardless of current HIV status. That could mean “the cost effectiveness of MSM vaccination may be even better than reported,” the researchers noted.
This study was funded primarily by the National Institute for Health Research and Public Health England in the United Kingdom. The authors had no relevant disclosures.
[email protected]On Twitter @whitneymcknight
Use of a quadrivalent HPV vaccine in men who have sex with men, administered in genitourinary specialty clinics, would cost effectively provide herd immunity against the ill effects of the virus, particularly anogenital warts and male HPV-related cancers, according to an English mathematical model.
Mark Jit, PhD, a professor of vaccine epidemiology at the London School of Hygiene & Tropical Medicine, and his colleagues considered in which settings HPV vaccination delivery would have the greatest effect size; the patterns of sexual behavior in MSM leading to the transmission of HPV 6, 11, 16, and 18; and the costs and quality adjusted life year (QALY) implications of disease outcomes (Clin Infect Dis. 2016 Dec 23. doi: 10.1093/cid/ciw845).
Clinic attendance rates were based on genitourinary clinic returns in England recorded in public health surveillance data recorded between 2009 and 2012, stratified according to diagnosed HIV-positive status. Also modeled were the effects of vaccination in MSM between the ages of 16 and 40 years, according to groups aged 16-25 years, 16-30 years, 16-35 years, and 16-40 years. Models for ages on either side of 16 or 40 years were not considered because of confidentiality constraints in the former and limited specialty clinic use in the latter.
Herd protection likely would be notable in the first year, because of the breadth of the age ranges modeled, Dr. Jit and his colleagues determined. Specifically, the models predicted a 35% decline in incidence rates of anogenital warts within 5 years of initiating the vaccine across all MSM men seen in specialty clinics. If only HIV-positive MSM across the age groups were vaccinated, the models predicted a 5-year decline of 15%.
Declines predicted in HPV-related cancers would happen more slowly, because progression from infection to malignancies tends to occur over years. For example, there would be a 55% reduction over 100 years for anal cancer if all 16- to 40-year-old MSM attending specialty clinics are offered vaccination. However, the reduction rate would drop to 40% in that same time period if only HIV-positive men across the age groups were vaccinated.
Using a cost-effectiveness threshold of 20,000 British pounds (about $24,500) per QALY, with no more than a 10% probability that the incremental cost-effectiveness ratio would exceed 30,000 pounds per QALY ($36,710), Dr. Jit and his colleagues determined that using a quadrivalent HPV vaccination in MSM between ages 16 and 40 years in the specialty clinic setting would be cost effective if delivery cost an average of 63 pounds ($77) per dose.
By offering vaccination only to HIV-positive MSM between 16 and 40 years, even if the quadrivalent vaccine were to cost as much as 96.50 pounds ($118), it would still be cost effective. A nonavalent vaccine at the same price would also be cost effective, because nearly all HPV-related cancers are linked to HPV 16 and 18. However, a bivalent vaccine was not shown by the models to be cost effective in such a limited program.
The investigators theorized that HIV infection is associated with the rate of HPV-related disease progression. To simplify computation, however, their models only considered the overall cost effectiveness of offering HPV vaccination to either HIV-positive MSM or to MSM regardless of current HIV status. That could mean “the cost effectiveness of MSM vaccination may be even better than reported,” the researchers noted.
This study was funded primarily by the National Institute for Health Research and Public Health England in the United Kingdom. The authors had no relevant disclosures.
[email protected]On Twitter @whitneymcknight
Key clinical point:
Major finding: Substantial declines in HPV-related events in MSM were projected within 5 years of vaccination between ages 16 and 40 years in this cohort.
Data source: Mathematical modeling of HPV 6, 11, 16, and 18 sexual transmission in the MSM population of England.
Disclosures: This study was funded primarily by the National Institute for Health Research and Public Health England in the United Kingdom. The authors had no relevant disclosures.
Everything We Say and Do: Use familiar terminology to allay patients’ fears
Editor’s note: “Everything We Say and Do” is an informational series developed by SHM ’s Patient Experience Committee to provide readers with thoughtful and actionable communication tactics that have great potential to positively impact patients’ experience of care. Each article will focus on how the contributor applies one or more of the “key communication” tactics in practice to maintain provider accountability for “everything we say and do that affects our patients’ thoughts, feelings, and well-being.”
What I say and do
I clearly explain diagnoses and treatment plans in plain terms.
Why I do it
We hear repeatedly from patients and families that a major source of their fear comes from “not knowing.” Fear of the unknown. If our patients and their families do not understand the message we are trying to communicate, these fears will be realized. It is our responsibility to explain their medical situation(s) to them in plain terms that they can comprehend, so as to allay those fears and enable them to become active, informed participants in their care.
How I do it
I start by reminding myself that I want to treat each patient as I would want a member of my own family to be treated. No one else in my family is in the medical field, so this means I must avoid medical terminology and use more familiar, everyday phrases. For example, I say “heart doctor” or “lung doctor” instead of “cardiologist” or “pulmonologist.” I also prefer “sonogram” to “ultrasound” because most people have heard that term in relation to a pregnancy. Even “EEG” and “EKG” need more plain descriptions.
I also try to use common, relatable analogies when explaining diseases. My favorite is to describe COPD (or any restrictive lung disease) like an old, hard sponge as compared with normal lungs, which are like a new, soft sponge.
I use the Teach-Back Method (which has already been well-discussed in this column by Dr. Trina Dorrah) to check for comprehension. If there are still issues with my message not being received as I had hoped, then I try again to find the terminology or an analogy that will connect with that patient.
Hopefully, using familiar, relatable language in this manner gives my patients and their families a better understanding of their diagnoses and care plans, quells their fears, and enhances their experience.
Dr. Sharp is a chief hospitalist with Sound Physicians at UF Health in Jacksonville, Fla., and a member of SHM's Patient Experience Committee.
Editor’s note: “Everything We Say and Do” is an informational series developed by SHM ’s Patient Experience Committee to provide readers with thoughtful and actionable communication tactics that have great potential to positively impact patients’ experience of care. Each article will focus on how the contributor applies one or more of the “key communication” tactics in practice to maintain provider accountability for “everything we say and do that affects our patients’ thoughts, feelings, and well-being.”
What I say and do
I clearly explain diagnoses and treatment plans in plain terms.
Why I do it
We hear repeatedly from patients and families that a major source of their fear comes from “not knowing.” Fear of the unknown. If our patients and their families do not understand the message we are trying to communicate, these fears will be realized. It is our responsibility to explain their medical situation(s) to them in plain terms that they can comprehend, so as to allay those fears and enable them to become active, informed participants in their care.
How I do it
I start by reminding myself that I want to treat each patient as I would want a member of my own family to be treated. No one else in my family is in the medical field, so this means I must avoid medical terminology and use more familiar, everyday phrases. For example, I say “heart doctor” or “lung doctor” instead of “cardiologist” or “pulmonologist.” I also prefer “sonogram” to “ultrasound” because most people have heard that term in relation to a pregnancy. Even “EEG” and “EKG” need more plain descriptions.
I also try to use common, relatable analogies when explaining diseases. My favorite is to describe COPD (or any restrictive lung disease) like an old, hard sponge as compared with normal lungs, which are like a new, soft sponge.
I use the Teach-Back Method (which has already been well-discussed in this column by Dr. Trina Dorrah) to check for comprehension. If there are still issues with my message not being received as I had hoped, then I try again to find the terminology or an analogy that will connect with that patient.
Hopefully, using familiar, relatable language in this manner gives my patients and their families a better understanding of their diagnoses and care plans, quells their fears, and enhances their experience.
Dr. Sharp is a chief hospitalist with Sound Physicians at UF Health in Jacksonville, Fla., and a member of SHM's Patient Experience Committee.
Editor’s note: “Everything We Say and Do” is an informational series developed by SHM ’s Patient Experience Committee to provide readers with thoughtful and actionable communication tactics that have great potential to positively impact patients’ experience of care. Each article will focus on how the contributor applies one or more of the “key communication” tactics in practice to maintain provider accountability for “everything we say and do that affects our patients’ thoughts, feelings, and well-being.”
What I say and do
I clearly explain diagnoses and treatment plans in plain terms.
Why I do it
We hear repeatedly from patients and families that a major source of their fear comes from “not knowing.” Fear of the unknown. If our patients and their families do not understand the message we are trying to communicate, these fears will be realized. It is our responsibility to explain their medical situation(s) to them in plain terms that they can comprehend, so as to allay those fears and enable them to become active, informed participants in their care.
How I do it
I start by reminding myself that I want to treat each patient as I would want a member of my own family to be treated. No one else in my family is in the medical field, so this means I must avoid medical terminology and use more familiar, everyday phrases. For example, I say “heart doctor” or “lung doctor” instead of “cardiologist” or “pulmonologist.” I also prefer “sonogram” to “ultrasound” because most people have heard that term in relation to a pregnancy. Even “EEG” and “EKG” need more plain descriptions.
I also try to use common, relatable analogies when explaining diseases. My favorite is to describe COPD (or any restrictive lung disease) like an old, hard sponge as compared with normal lungs, which are like a new, soft sponge.
I use the Teach-Back Method (which has already been well-discussed in this column by Dr. Trina Dorrah) to check for comprehension. If there are still issues with my message not being received as I had hoped, then I try again to find the terminology or an analogy that will connect with that patient.
Hopefully, using familiar, relatable language in this manner gives my patients and their families a better understanding of their diagnoses and care plans, quells their fears, and enhances their experience.
Dr. Sharp is a chief hospitalist with Sound Physicians at UF Health in Jacksonville, Fla., and a member of SHM's Patient Experience Committee.
Cabozantinib shows promise for carcinoid tumors, pNET
SAN FRANCISCO – Treatment with cabozantinib was associated with objective tumor responses and encouraging progression-free survival in patients with advanced carcinoid and pancreatic neuroendocrine tumors in a two-cohort phase II trial.
Of 41 patients in the carcinoid tumor cohort, 6 achieved RECIST-defined partial response (objective response rate, 15%), and 26 had stable disease. Median progression-free survival was 31.4 months.
Of 20 patients in the pancreatic neuroendocrine tumors (pNET) cohort, 3 achieved a partial response (objective response rate, 15%), and 15 had stable disease. Median progression-free survival was 21.8 months, Jennifer A. Chan, MD, reported at the symposium, sponsored by ASCO, ASTRO, the American Gastroenterological Association, and the Society of Surgical Oncology.
Although dose reduction was common – occurring in 81% of 53 patients who completed at least one treatment cycle – treatment was tolerable, said Dr. Chan of Dana-Farber Cancer Institute, Boston.
Study patients had progressive, well-differentiated grade 1-2 carcinoid tumors or pNET, and were treated with 60 mg of oral cabozantinib daily. There were no limits on prior therapy, and patients were restaged every 2 months for the first 6 months, then every 3 months thereafter.
The 41 patients with carcinoid tumors had a median age of 63 years and ECOG performance status of 0 or 1. Only 20 patients were enrolled in the pNET group, because accrual was halted, in part because of funding considerations. Patients in that group had a median age of 55 years, and also had ECOG performance status of 0 or 1, Dr. Chan said.
Carcinoid tumor patients completed a median of 8 28-day treatment cycles (range, 0-44), and pNET patients completed a median of 10 cycles (range, 0-25).
The most common reasons for discontinuation were progression or death in 51% of patients, withdrawal of consent or investigator decision in 28%, and adverse events in 21%, she noted.
The most common grade 3/4 toxicities included hypertension in 13% of patients, hypophosphatemia in 11%, and diarrhea in 10%.
Unexpected grade 3/4 events included heart failure and autoimmune hemolytic anemia, which each occurred in 1 patient.
This phase II study was initiated in light of promising preclinical work, Dr. Chan said.
“There has been much progress in recent years in the treatment of advanced neuroendocrine tumors,” she said. “The VEGF pathway inhibitors have been demonstrated to show activity, and the tyrosine kinase inhibitor sunitinib is approved for patients with progressive pancreatic neuroendocrine tumors.”
Recent studies also suggest that inhibition of MET may be an effective treatment strategy. MET activation has been shown to be associated with tumor growth, expression of MET has been observed in a significant proportion of neuroendocrine tumors, and increased expression of MET has been associated with decreased overall survival in pancreatic neuroendocrine tumors, she noted.
“Cabozantinib is a tyrosine kinase inhibitor that targets multiple receptors, including the VEGF receptors MET, ASL, and RET,” Dr. Chan explained. “It improves progression-free survival in advanced renal cell carcinoma in the first-line setting, compared with sunitinib, and also in the second-line setting, compared with everolimus in patients previously treated with anti-angiogenic therapy.” Cabozantinib is also approved for use in patients with progressive, metastatic medullary thyroid carcinoma, she added.
In preclinical models of neuroendocrine tumors, cabozantinib inhibited cell viability, and in a mouse model it decreased metastasis and invasion of pNET.
The current findings provide further evidence of cabozantinib’s safety and efficacy, Dr. Chan said. The progression-free survival in this phase II study is of particularly interest in the context of historical results, she added.
“Recognizing the limitations of interpreting progression-free survival data in an uncontrolled phase II trial, as well as comparing data to previous clinical trials, the progression-free survival results that we observed do appear encouraging,” she said. “It will be important to confirm the activity of cabozantinib in a randomized phase III setting.”
Dr. Chan reported having stock or other ownership interests in Merck; having a consulting or advisory role with Bayer, Ipsen, Novartis, Pfizer, and Pozen; and receiving research funding from Novartis and Sanofi.
SAN FRANCISCO – Treatment with cabozantinib was associated with objective tumor responses and encouraging progression-free survival in patients with advanced carcinoid and pancreatic neuroendocrine tumors in a two-cohort phase II trial.
Of 41 patients in the carcinoid tumor cohort, 6 achieved RECIST-defined partial response (objective response rate, 15%), and 26 had stable disease. Median progression-free survival was 31.4 months.
Of 20 patients in the pancreatic neuroendocrine tumors (pNET) cohort, 3 achieved a partial response (objective response rate, 15%), and 15 had stable disease. Median progression-free survival was 21.8 months, Jennifer A. Chan, MD, reported at the symposium, sponsored by ASCO, ASTRO, the American Gastroenterological Association, and the Society of Surgical Oncology.
Although dose reduction was common – occurring in 81% of 53 patients who completed at least one treatment cycle – treatment was tolerable, said Dr. Chan of Dana-Farber Cancer Institute, Boston.
Study patients had progressive, well-differentiated grade 1-2 carcinoid tumors or pNET, and were treated with 60 mg of oral cabozantinib daily. There were no limits on prior therapy, and patients were restaged every 2 months for the first 6 months, then every 3 months thereafter.
The 41 patients with carcinoid tumors had a median age of 63 years and ECOG performance status of 0 or 1. Only 20 patients were enrolled in the pNET group, because accrual was halted, in part because of funding considerations. Patients in that group had a median age of 55 years, and also had ECOG performance status of 0 or 1, Dr. Chan said.
Carcinoid tumor patients completed a median of 8 28-day treatment cycles (range, 0-44), and pNET patients completed a median of 10 cycles (range, 0-25).
The most common reasons for discontinuation were progression or death in 51% of patients, withdrawal of consent or investigator decision in 28%, and adverse events in 21%, she noted.
The most common grade 3/4 toxicities included hypertension in 13% of patients, hypophosphatemia in 11%, and diarrhea in 10%.
Unexpected grade 3/4 events included heart failure and autoimmune hemolytic anemia, which each occurred in 1 patient.
This phase II study was initiated in light of promising preclinical work, Dr. Chan said.
“There has been much progress in recent years in the treatment of advanced neuroendocrine tumors,” she said. “The VEGF pathway inhibitors have been demonstrated to show activity, and the tyrosine kinase inhibitor sunitinib is approved for patients with progressive pancreatic neuroendocrine tumors.”
Recent studies also suggest that inhibition of MET may be an effective treatment strategy. MET activation has been shown to be associated with tumor growth, expression of MET has been observed in a significant proportion of neuroendocrine tumors, and increased expression of MET has been associated with decreased overall survival in pancreatic neuroendocrine tumors, she noted.
“Cabozantinib is a tyrosine kinase inhibitor that targets multiple receptors, including the VEGF receptors MET, ASL, and RET,” Dr. Chan explained. “It improves progression-free survival in advanced renal cell carcinoma in the first-line setting, compared with sunitinib, and also in the second-line setting, compared with everolimus in patients previously treated with anti-angiogenic therapy.” Cabozantinib is also approved for use in patients with progressive, metastatic medullary thyroid carcinoma, she added.
In preclinical models of neuroendocrine tumors, cabozantinib inhibited cell viability, and in a mouse model it decreased metastasis and invasion of pNET.
The current findings provide further evidence of cabozantinib’s safety and efficacy, Dr. Chan said. The progression-free survival in this phase II study is of particularly interest in the context of historical results, she added.
“Recognizing the limitations of interpreting progression-free survival data in an uncontrolled phase II trial, as well as comparing data to previous clinical trials, the progression-free survival results that we observed do appear encouraging,” she said. “It will be important to confirm the activity of cabozantinib in a randomized phase III setting.”
Dr. Chan reported having stock or other ownership interests in Merck; having a consulting or advisory role with Bayer, Ipsen, Novartis, Pfizer, and Pozen; and receiving research funding from Novartis and Sanofi.
SAN FRANCISCO – Treatment with cabozantinib was associated with objective tumor responses and encouraging progression-free survival in patients with advanced carcinoid and pancreatic neuroendocrine tumors in a two-cohort phase II trial.
Of 41 patients in the carcinoid tumor cohort, 6 achieved RECIST-defined partial response (objective response rate, 15%), and 26 had stable disease. Median progression-free survival was 31.4 months.
Of 20 patients in the pancreatic neuroendocrine tumors (pNET) cohort, 3 achieved a partial response (objective response rate, 15%), and 15 had stable disease. Median progression-free survival was 21.8 months, Jennifer A. Chan, MD, reported at the symposium, sponsored by ASCO, ASTRO, the American Gastroenterological Association, and the Society of Surgical Oncology.
Although dose reduction was common – occurring in 81% of 53 patients who completed at least one treatment cycle – treatment was tolerable, said Dr. Chan of Dana-Farber Cancer Institute, Boston.
Study patients had progressive, well-differentiated grade 1-2 carcinoid tumors or pNET, and were treated with 60 mg of oral cabozantinib daily. There were no limits on prior therapy, and patients were restaged every 2 months for the first 6 months, then every 3 months thereafter.
The 41 patients with carcinoid tumors had a median age of 63 years and ECOG performance status of 0 or 1. Only 20 patients were enrolled in the pNET group, because accrual was halted, in part because of funding considerations. Patients in that group had a median age of 55 years, and also had ECOG performance status of 0 or 1, Dr. Chan said.
Carcinoid tumor patients completed a median of 8 28-day treatment cycles (range, 0-44), and pNET patients completed a median of 10 cycles (range, 0-25).
The most common reasons for discontinuation were progression or death in 51% of patients, withdrawal of consent or investigator decision in 28%, and adverse events in 21%, she noted.
The most common grade 3/4 toxicities included hypertension in 13% of patients, hypophosphatemia in 11%, and diarrhea in 10%.
Unexpected grade 3/4 events included heart failure and autoimmune hemolytic anemia, which each occurred in 1 patient.
This phase II study was initiated in light of promising preclinical work, Dr. Chan said.
“There has been much progress in recent years in the treatment of advanced neuroendocrine tumors,” she said. “The VEGF pathway inhibitors have been demonstrated to show activity, and the tyrosine kinase inhibitor sunitinib is approved for patients with progressive pancreatic neuroendocrine tumors.”
Recent studies also suggest that inhibition of MET may be an effective treatment strategy. MET activation has been shown to be associated with tumor growth, expression of MET has been observed in a significant proportion of neuroendocrine tumors, and increased expression of MET has been associated with decreased overall survival in pancreatic neuroendocrine tumors, she noted.
“Cabozantinib is a tyrosine kinase inhibitor that targets multiple receptors, including the VEGF receptors MET, ASL, and RET,” Dr. Chan explained. “It improves progression-free survival in advanced renal cell carcinoma in the first-line setting, compared with sunitinib, and also in the second-line setting, compared with everolimus in patients previously treated with anti-angiogenic therapy.” Cabozantinib is also approved for use in patients with progressive, metastatic medullary thyroid carcinoma, she added.
In preclinical models of neuroendocrine tumors, cabozantinib inhibited cell viability, and in a mouse model it decreased metastasis and invasion of pNET.
The current findings provide further evidence of cabozantinib’s safety and efficacy, Dr. Chan said. The progression-free survival in this phase II study is of particularly interest in the context of historical results, she added.
“Recognizing the limitations of interpreting progression-free survival data in an uncontrolled phase II trial, as well as comparing data to previous clinical trials, the progression-free survival results that we observed do appear encouraging,” she said. “It will be important to confirm the activity of cabozantinib in a randomized phase III setting.”
Dr. Chan reported having stock or other ownership interests in Merck; having a consulting or advisory role with Bayer, Ipsen, Novartis, Pfizer, and Pozen; and receiving research funding from Novartis and Sanofi.
Key clinical point:
Major finding: The objective response rate was 15% in both groups; median progression-free survival was 31.4 and 21.8 months in the carcinoid and pNET groups, respectively.
Data source: A phase II trial involving 61 patients.
Disclosures: Dr. Chan reported having stock or other ownership interests in Merck; having a consulting or advisory role with Bayer, Ipsen, Novartis, Pfizer, and Pozen; and receiving research funding from Novartis and Sanofi.
In ICU, pair MRSA testing method with isolation protocol
An ICU’s method of testing for methicillin-resistant Staphylococcus aureus (MRSA) should be paired with its patient isolation policy, according to researchers at the University of Colorado at Denver.
In an ICU with all patients preemptively isolated, it is worth the added expense to opt for the polymerase chain reaction (PCR) test – which generates results in a few hours – so that patients negative for the infection can be moved out of isolation more quickly, wrote Melanie D. Whittington, PhD, and her coauthors. But if the ICU is only isolating MRSA-positive patients, the authors instead recommend the less expensive but slower chromogenic agar 24-hour testing.
The other two MRSA tests the researchers assessed – conventional culture and chromogenic agar 48-hour testing – are less expensive. But when paired with either ICU isolation policy, those tests lead to excessive inappropriate isolation costs while waiting for the results, the study investigators cautioned (Am J Infect Control. 2017 Jan 23. doi: 10.1016/j.ajic.2016.12.014).
Adding together the cost per patient of the test, the “appropriate isolation costs,” and “inappropriate isolation costs,” the universal isolation policy is least expensive per patient with PCR, at $82.51 per patient. With conventional culture, which can take several days, this cost ballooned to $290.11 per patient, with high inappropriate isolation costs.
Doing the same math with the more targeted isolation policy, the least expensive screening method was the 24-hour chromogenic agar, at $8.54 per patient, while the expense of the PCR test made it the most expensive method when paired with this isolation policy, at $30.95 per patient.
“With knowledge of the screening test that minimizes inappropriate and total costs, hospitals can maximize the efficiency of their resource use and improve the health of their patients,” Dr. Whittington and her coauthors wrote.
The authors reported no conflicts of interest.
An ICU’s method of testing for methicillin-resistant Staphylococcus aureus (MRSA) should be paired with its patient isolation policy, according to researchers at the University of Colorado at Denver.
In an ICU with all patients preemptively isolated, it is worth the added expense to opt for the polymerase chain reaction (PCR) test – which generates results in a few hours – so that patients negative for the infection can be moved out of isolation more quickly, wrote Melanie D. Whittington, PhD, and her coauthors. But if the ICU is only isolating MRSA-positive patients, the authors instead recommend the less expensive but slower chromogenic agar 24-hour testing.
The other two MRSA tests the researchers assessed – conventional culture and chromogenic agar 48-hour testing – are less expensive. But when paired with either ICU isolation policy, those tests lead to excessive inappropriate isolation costs while waiting for the results, the study investigators cautioned (Am J Infect Control. 2017 Jan 23. doi: 10.1016/j.ajic.2016.12.014).
Adding together the cost per patient of the test, the “appropriate isolation costs,” and “inappropriate isolation costs,” the universal isolation policy is least expensive per patient with PCR, at $82.51 per patient. With conventional culture, which can take several days, this cost ballooned to $290.11 per patient, with high inappropriate isolation costs.
Doing the same math with the more targeted isolation policy, the least expensive screening method was the 24-hour chromogenic agar, at $8.54 per patient, while the expense of the PCR test made it the most expensive method when paired with this isolation policy, at $30.95 per patient.
“With knowledge of the screening test that minimizes inappropriate and total costs, hospitals can maximize the efficiency of their resource use and improve the health of their patients,” Dr. Whittington and her coauthors wrote.
The authors reported no conflicts of interest.
An ICU’s method of testing for methicillin-resistant Staphylococcus aureus (MRSA) should be paired with its patient isolation policy, according to researchers at the University of Colorado at Denver.
In an ICU with all patients preemptively isolated, it is worth the added expense to opt for the polymerase chain reaction (PCR) test – which generates results in a few hours – so that patients negative for the infection can be moved out of isolation more quickly, wrote Melanie D. Whittington, PhD, and her coauthors. But if the ICU is only isolating MRSA-positive patients, the authors instead recommend the less expensive but slower chromogenic agar 24-hour testing.
The other two MRSA tests the researchers assessed – conventional culture and chromogenic agar 48-hour testing – are less expensive. But when paired with either ICU isolation policy, those tests lead to excessive inappropriate isolation costs while waiting for the results, the study investigators cautioned (Am J Infect Control. 2017 Jan 23. doi: 10.1016/j.ajic.2016.12.014).
Adding together the cost per patient of the test, the “appropriate isolation costs,” and “inappropriate isolation costs,” the universal isolation policy is least expensive per patient with PCR, at $82.51 per patient. With conventional culture, which can take several days, this cost ballooned to $290.11 per patient, with high inappropriate isolation costs.
Doing the same math with the more targeted isolation policy, the least expensive screening method was the 24-hour chromogenic agar, at $8.54 per patient, while the expense of the PCR test made it the most expensive method when paired with this isolation policy, at $30.95 per patient.
“With knowledge of the screening test that minimizes inappropriate and total costs, hospitals can maximize the efficiency of their resource use and improve the health of their patients,” Dr. Whittington and her coauthors wrote.
The authors reported no conflicts of interest.
Capping gestational weight gain didn’t deliver better pregnancy outcomes
LAS VEGAS – Two similar behavioral interventions during pregnancy both succeeded in capping gestational weight gain in two independent randomized trials, but neither intervention produced improvements in obstetrical outcomes.
Results from several prior studies linked excess gestational weight gain (GWG) with adverse outcomes, including gestational diabetes, hypertension, macrosomia, and cesarean delivery. But none of the rates of these complications fell among women in the study groups that received intervention and had reduced GWG, compared with controls.
“The clinical significance of the difference in GWG we saw is not known,” said Alison G. Cahill, MD, who presented one of the two reports at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. In the study she led, women who received a behavioral intervention averaged about 3.5 pounds less GWG through 36 weeks of pregnancy.
“Our findings call into question the association between GWG and adverse pregnancy outcomes,” said Alan M. Peaceman, MD, who presented the second study, in which women receiving the behavioral intervention averaged 4 pounds less in GWG, compared with control women.
Dr. Peaceman reported results from the Maternal Offspring Metabolics: Family Intervention Trial (MOMFIT), a trial run at Northwestern University in Chicago that randomized 263 pregnant women. The women had to be at less than 16 weeks singleton gestation with a body mass index of 25-40 kg/m2, no pregestational diabetes, and a first trimester weight gain of no more than 15 pounds.
The researchers randomized participants to receive either an intervention that included an individualized diet, Internet-based self monitoring of diet adherence, recommendations on physical activity, and weekly coaching calls and opportunities for group meetings, webinars and podcasts; or a control regimen of electronic newsletters and website access that dispensed pregnancy information without mentioning diet. The participants averaged 33 years old, their average body mass index was 31 kg/m2, and about 55% were obese, with a body mass index of 30 kg/m2 or greater.
The study’s primary outcome was weight gain from enrollment through 36 weeks of gestation, which averaged 19.1 pounds among women who received the intervention and 23.7 pounds among controls, an average 4.6 pounds difference that was statistically significant, Dr. Peaceman reported.
The percentage of patients exceeding the GWG recommendations made in 2009 by the Institute of Medicine (IOM) was 68% in the intervention group and 86% among the controls, an 18 percentage-point difference that was statistically significant.
Despite these differences, the two groups showed very similar rates for the incidence of gestational diabetes, preeclampsia or hypertension, birth weight above 4,000 g, and gestational age at delivery (39 weeks on average for both subgroups).
The rate of cesarean delivery (40%) was higher in the women who received the intervention and had less GWG, compared with 27% among the control women. Despite meeting the statistical test for significance, it is most likely a chance result, said Dr. Peaceman, chief of maternal fetal medicine at Northwestern.
He stressed that while no benefit from reduced GWG has yet been found in the MOMFIT results, additional endpoints are under study, such as neonatal metabolism, infant metabolism at 1 year, and maternal weight retention.
Dr. Cahill reported very similar findings from her study, run as part of the Weight Management in Obese Pregnant Underserved African American Women (LIFE-Moms) trial. She enrolled 267 socioeconomically disadvantaged African American women with singleton, normal-anatomy pregnancies who presented for prenatal care at her clinic at less than 16 weeks gestation and were overweight or obese.
The study randomized these women to receive either an exercise and lifestyle intervention along with home visits from the Parents as Teachers program, or just home visits without the exercise and lifestyle component. The enrolled women averaged about 25 years old, and their average body mass index was about 32 kg/m2, with two-thirds of patients being obese.
The study’s primary endpoint, the percentage of women who exceeded the IOM’s 2009 recommendations on GWG, was 37% among women who received the exercise and lifestyle intervention and 46% among those who did not, a difference that was not statistically significant in the full intention-to-treat analysis, Dr. Cahill reported.
A subgroup analysis showed that most of the benefit focused in obese participants, where 34% of women who received the extra intervention had a GWG greater than the IOM recommendation, compared with a 49% rate among controls, a 15 percentage-point difference that fell just short of statistical significance.
For the secondary endpoint of average amount of GWG, women in the intervention arm had a 8.05 kg average, compared with 9.64 kg among the controls, an average GWG reduction of 1.59 kg (3.5 pounds) in the intervention arm. This difference was statistically significant, said Dr. Cahill, chief of maternal fetal medicine at Washington University in St. Louis.
Dr. Cahill also ran a modified intention-to-treat analysis that excluded women with missing GWG data at term, those with fetal death or miscarriage, and one women mistakenly enrolled who was of normal weight. Among the remaining 240 women, the impact of the exercise and lifestyle intervention was even more pronounced, resulting in an average reduction in GWG of 4 pounds and a 12 percentage-point reduction in women exceeding the IOM’s GWG recommendations.
Despite these favorable effects on GWG, the two study arms showed no significant differences in the incidence of gestational diabetes, gestational hypertension, preterm births, or cesarean delivery.
Dr. Cahill said that she too planned to look at additional outcomes that might be affected by controlling GWG, including maternal weight retention and neurodevelopment in the children.
[email protected] On Twitter @mitchelzoler
LAS VEGAS – Two similar behavioral interventions during pregnancy both succeeded in capping gestational weight gain in two independent randomized trials, but neither intervention produced improvements in obstetrical outcomes.
Results from several prior studies linked excess gestational weight gain (GWG) with adverse outcomes, including gestational diabetes, hypertension, macrosomia, and cesarean delivery. But none of the rates of these complications fell among women in the study groups that received intervention and had reduced GWG, compared with controls.
“The clinical significance of the difference in GWG we saw is not known,” said Alison G. Cahill, MD, who presented one of the two reports at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. In the study she led, women who received a behavioral intervention averaged about 3.5 pounds less GWG through 36 weeks of pregnancy.
“Our findings call into question the association between GWG and adverse pregnancy outcomes,” said Alan M. Peaceman, MD, who presented the second study, in which women receiving the behavioral intervention averaged 4 pounds less in GWG, compared with control women.
Dr. Peaceman reported results from the Maternal Offspring Metabolics: Family Intervention Trial (MOMFIT), a trial run at Northwestern University in Chicago that randomized 263 pregnant women. The women had to be at less than 16 weeks singleton gestation with a body mass index of 25-40 kg/m2, no pregestational diabetes, and a first trimester weight gain of no more than 15 pounds.
The researchers randomized participants to receive either an intervention that included an individualized diet, Internet-based self monitoring of diet adherence, recommendations on physical activity, and weekly coaching calls and opportunities for group meetings, webinars and podcasts; or a control regimen of electronic newsletters and website access that dispensed pregnancy information without mentioning diet. The participants averaged 33 years old, their average body mass index was 31 kg/m2, and about 55% were obese, with a body mass index of 30 kg/m2 or greater.
The study’s primary outcome was weight gain from enrollment through 36 weeks of gestation, which averaged 19.1 pounds among women who received the intervention and 23.7 pounds among controls, an average 4.6 pounds difference that was statistically significant, Dr. Peaceman reported.
The percentage of patients exceeding the GWG recommendations made in 2009 by the Institute of Medicine (IOM) was 68% in the intervention group and 86% among the controls, an 18 percentage-point difference that was statistically significant.
Despite these differences, the two groups showed very similar rates for the incidence of gestational diabetes, preeclampsia or hypertension, birth weight above 4,000 g, and gestational age at delivery (39 weeks on average for both subgroups).
The rate of cesarean delivery (40%) was higher in the women who received the intervention and had less GWG, compared with 27% among the control women. Despite meeting the statistical test for significance, it is most likely a chance result, said Dr. Peaceman, chief of maternal fetal medicine at Northwestern.
He stressed that while no benefit from reduced GWG has yet been found in the MOMFIT results, additional endpoints are under study, such as neonatal metabolism, infant metabolism at 1 year, and maternal weight retention.
Dr. Cahill reported very similar findings from her study, run as part of the Weight Management in Obese Pregnant Underserved African American Women (LIFE-Moms) trial. She enrolled 267 socioeconomically disadvantaged African American women with singleton, normal-anatomy pregnancies who presented for prenatal care at her clinic at less than 16 weeks gestation and were overweight or obese.
The study randomized these women to receive either an exercise and lifestyle intervention along with home visits from the Parents as Teachers program, or just home visits without the exercise and lifestyle component. The enrolled women averaged about 25 years old, and their average body mass index was about 32 kg/m2, with two-thirds of patients being obese.
The study’s primary endpoint, the percentage of women who exceeded the IOM’s 2009 recommendations on GWG, was 37% among women who received the exercise and lifestyle intervention and 46% among those who did not, a difference that was not statistically significant in the full intention-to-treat analysis, Dr. Cahill reported.
A subgroup analysis showed that most of the benefit focused in obese participants, where 34% of women who received the extra intervention had a GWG greater than the IOM recommendation, compared with a 49% rate among controls, a 15 percentage-point difference that fell just short of statistical significance.
For the secondary endpoint of average amount of GWG, women in the intervention arm had a 8.05 kg average, compared with 9.64 kg among the controls, an average GWG reduction of 1.59 kg (3.5 pounds) in the intervention arm. This difference was statistically significant, said Dr. Cahill, chief of maternal fetal medicine at Washington University in St. Louis.
Dr. Cahill also ran a modified intention-to-treat analysis that excluded women with missing GWG data at term, those with fetal death or miscarriage, and one women mistakenly enrolled who was of normal weight. Among the remaining 240 women, the impact of the exercise and lifestyle intervention was even more pronounced, resulting in an average reduction in GWG of 4 pounds and a 12 percentage-point reduction in women exceeding the IOM’s GWG recommendations.
Despite these favorable effects on GWG, the two study arms showed no significant differences in the incidence of gestational diabetes, gestational hypertension, preterm births, or cesarean delivery.
Dr. Cahill said that she too planned to look at additional outcomes that might be affected by controlling GWG, including maternal weight retention and neurodevelopment in the children.
[email protected] On Twitter @mitchelzoler
LAS VEGAS – Two similar behavioral interventions during pregnancy both succeeded in capping gestational weight gain in two independent randomized trials, but neither intervention produced improvements in obstetrical outcomes.
Results from several prior studies linked excess gestational weight gain (GWG) with adverse outcomes, including gestational diabetes, hypertension, macrosomia, and cesarean delivery. But none of the rates of these complications fell among women in the study groups that received intervention and had reduced GWG, compared with controls.
“The clinical significance of the difference in GWG we saw is not known,” said Alison G. Cahill, MD, who presented one of the two reports at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine. In the study she led, women who received a behavioral intervention averaged about 3.5 pounds less GWG through 36 weeks of pregnancy.
“Our findings call into question the association between GWG and adverse pregnancy outcomes,” said Alan M. Peaceman, MD, who presented the second study, in which women receiving the behavioral intervention averaged 4 pounds less in GWG, compared with control women.
Dr. Peaceman reported results from the Maternal Offspring Metabolics: Family Intervention Trial (MOMFIT), a trial run at Northwestern University in Chicago that randomized 263 pregnant women. The women had to be at less than 16 weeks singleton gestation with a body mass index of 25-40 kg/m2, no pregestational diabetes, and a first trimester weight gain of no more than 15 pounds.
The researchers randomized participants to receive either an intervention that included an individualized diet, Internet-based self monitoring of diet adherence, recommendations on physical activity, and weekly coaching calls and opportunities for group meetings, webinars and podcasts; or a control regimen of electronic newsletters and website access that dispensed pregnancy information without mentioning diet. The participants averaged 33 years old, their average body mass index was 31 kg/m2, and about 55% were obese, with a body mass index of 30 kg/m2 or greater.
The study’s primary outcome was weight gain from enrollment through 36 weeks of gestation, which averaged 19.1 pounds among women who received the intervention and 23.7 pounds among controls, an average 4.6 pounds difference that was statistically significant, Dr. Peaceman reported.
The percentage of patients exceeding the GWG recommendations made in 2009 by the Institute of Medicine (IOM) was 68% in the intervention group and 86% among the controls, an 18 percentage-point difference that was statistically significant.
Despite these differences, the two groups showed very similar rates for the incidence of gestational diabetes, preeclampsia or hypertension, birth weight above 4,000 g, and gestational age at delivery (39 weeks on average for both subgroups).
The rate of cesarean delivery (40%) was higher in the women who received the intervention and had less GWG, compared with 27% among the control women. Despite meeting the statistical test for significance, it is most likely a chance result, said Dr. Peaceman, chief of maternal fetal medicine at Northwestern.
He stressed that while no benefit from reduced GWG has yet been found in the MOMFIT results, additional endpoints are under study, such as neonatal metabolism, infant metabolism at 1 year, and maternal weight retention.
Dr. Cahill reported very similar findings from her study, run as part of the Weight Management in Obese Pregnant Underserved African American Women (LIFE-Moms) trial. She enrolled 267 socioeconomically disadvantaged African American women with singleton, normal-anatomy pregnancies who presented for prenatal care at her clinic at less than 16 weeks gestation and were overweight or obese.
The study randomized these women to receive either an exercise and lifestyle intervention along with home visits from the Parents as Teachers program, or just home visits without the exercise and lifestyle component. The enrolled women averaged about 25 years old, and their average body mass index was about 32 kg/m2, with two-thirds of patients being obese.
The study’s primary endpoint, the percentage of women who exceeded the IOM’s 2009 recommendations on GWG, was 37% among women who received the exercise and lifestyle intervention and 46% among those who did not, a difference that was not statistically significant in the full intention-to-treat analysis, Dr. Cahill reported.
A subgroup analysis showed that most of the benefit focused in obese participants, where 34% of women who received the extra intervention had a GWG greater than the IOM recommendation, compared with a 49% rate among controls, a 15 percentage-point difference that fell just short of statistical significance.
For the secondary endpoint of average amount of GWG, women in the intervention arm had a 8.05 kg average, compared with 9.64 kg among the controls, an average GWG reduction of 1.59 kg (3.5 pounds) in the intervention arm. This difference was statistically significant, said Dr. Cahill, chief of maternal fetal medicine at Washington University in St. Louis.
Dr. Cahill also ran a modified intention-to-treat analysis that excluded women with missing GWG data at term, those with fetal death or miscarriage, and one women mistakenly enrolled who was of normal weight. Among the remaining 240 women, the impact of the exercise and lifestyle intervention was even more pronounced, resulting in an average reduction in GWG of 4 pounds and a 12 percentage-point reduction in women exceeding the IOM’s GWG recommendations.
Despite these favorable effects on GWG, the two study arms showed no significant differences in the incidence of gestational diabetes, gestational hypertension, preterm births, or cesarean delivery.
Dr. Cahill said that she too planned to look at additional outcomes that might be affected by controlling GWG, including maternal weight retention and neurodevelopment in the children.
[email protected] On Twitter @mitchelzoler
Key clinical point:
Major finding: Behavioral interventions linked with average reductions in gestational weight gain of 4.6 pounds in MOMFIT and 3.5 pounds in LIFE-Moms.
Data source: MOMFIT and LIFE-Moms, two single-center randomized trials with 263 and 267 mothers, respectively.
Disclosures: Neither trial had commercial support. Dr. Peaceman and Dr. Cahill had no relevant disclosures.
After TAVR, 1 in 10 Medicare patients need permanent pacemaker
HOUSTON – About 1 in 10 Medicare patients require implantation of a permanent pacemaker following transcatheter aortic valve replacement, results from a large analysis showed.
“There is conflicting evidence and some debate over permanent pacemaker placement following transcatheter aortic valve replacement – whether it has a protective or adverse effect, and how often it takes place,” study investigator Fenton H. McCarthy, MD, said in an interview at the annual meeting of the Society of Thoracic Surgeons.
One recent study found that permanent pacemaker placement within 30 days post TAVR was found in 6.7% of patients undergoing balloon-expanding or self-expanding valve implantation, and is associated with increased mortality and hospitalizations (JACC Cardiovasc Interv. 2016 Nov 14;9[21]:2189-2199).
To evaluate the relationship between permanent pacemaker implantation and long-term patient outcomes among Medicare beneficiaries undergoing TAVR, Dr. McCarthy, a cardiothoracic surgery fellow at the University of Pennsylvania, Philadelphia, and his associates used Medicare carrier claims and Medicare Provider Analysis and Review files to identify 14,305 TAVR patients between January 2011 and December 2013.
The researchers used univariate Kaplan survival estimates and multivariable models to analyze survival, readmission and risk factors for pacemaker implantation.
The mean age of the 14,305 TAVR patients studied was 83 years, and 11% received a permanent pacemaker after TAVR. Of these, 9% received the pacemaker at index hospitalization, 1% at 30 days after implant, 0.5% at 90 days after implant, and 1% at 1 year after implant. Patient age of greater than 90 years was a significant predictor of pacemaker placement, with an odds ratio of 1.7 (P less than .01).
Dr. McCarthy and his associates observed that the readmission rates for pacemaker placement and no pacemaker placement at index hospitalization were similar at 30 days (21% vs. 19%, respectively), at 90 days (33% vs. 31%) and at 1 year (43% in both groups of patients).
In addition, Kaplan Meier estimates revealed no significant difference in long-term survival for patients with pacemaker placement within 30 days of TAVR, while multivariate Cox proportional hazard modeling revealed that pacemaker placement is not a predictor of long-term mortality (hazard ratio, 1.03; P = .65).
“This was the largest study to evaluate the question of incidence and effect of permanent pacemaker in the transcatheter aortic valve replacement population in the United States,” Dr. McCarthy said. “The size of our data set and the fact that the Medicare database includes all types of patients, regardless of trial participation, study or registry, is a strength of this study. Some other studies have used different inclusion and exclusion criteria. We used broad inclusion criteria and evaluated patients from as many different centers as possible.”
A key limitation of the study, he said, was that the researchers were unable to determine whether a patient received a balloon-expanding or self-expanding TAVR.
Dr. McCarthy reported having no financial disclosures.
HOUSTON – About 1 in 10 Medicare patients require implantation of a permanent pacemaker following transcatheter aortic valve replacement, results from a large analysis showed.
“There is conflicting evidence and some debate over permanent pacemaker placement following transcatheter aortic valve replacement – whether it has a protective or adverse effect, and how often it takes place,” study investigator Fenton H. McCarthy, MD, said in an interview at the annual meeting of the Society of Thoracic Surgeons.
One recent study found that permanent pacemaker placement within 30 days post TAVR was found in 6.7% of patients undergoing balloon-expanding or self-expanding valve implantation, and is associated with increased mortality and hospitalizations (JACC Cardiovasc Interv. 2016 Nov 14;9[21]:2189-2199).
To evaluate the relationship between permanent pacemaker implantation and long-term patient outcomes among Medicare beneficiaries undergoing TAVR, Dr. McCarthy, a cardiothoracic surgery fellow at the University of Pennsylvania, Philadelphia, and his associates used Medicare carrier claims and Medicare Provider Analysis and Review files to identify 14,305 TAVR patients between January 2011 and December 2013.
The researchers used univariate Kaplan survival estimates and multivariable models to analyze survival, readmission and risk factors for pacemaker implantation.
The mean age of the 14,305 TAVR patients studied was 83 years, and 11% received a permanent pacemaker after TAVR. Of these, 9% received the pacemaker at index hospitalization, 1% at 30 days after implant, 0.5% at 90 days after implant, and 1% at 1 year after implant. Patient age of greater than 90 years was a significant predictor of pacemaker placement, with an odds ratio of 1.7 (P less than .01).
Dr. McCarthy and his associates observed that the readmission rates for pacemaker placement and no pacemaker placement at index hospitalization were similar at 30 days (21% vs. 19%, respectively), at 90 days (33% vs. 31%) and at 1 year (43% in both groups of patients).
In addition, Kaplan Meier estimates revealed no significant difference in long-term survival for patients with pacemaker placement within 30 days of TAVR, while multivariate Cox proportional hazard modeling revealed that pacemaker placement is not a predictor of long-term mortality (hazard ratio, 1.03; P = .65).
“This was the largest study to evaluate the question of incidence and effect of permanent pacemaker in the transcatheter aortic valve replacement population in the United States,” Dr. McCarthy said. “The size of our data set and the fact that the Medicare database includes all types of patients, regardless of trial participation, study or registry, is a strength of this study. Some other studies have used different inclusion and exclusion criteria. We used broad inclusion criteria and evaluated patients from as many different centers as possible.”
A key limitation of the study, he said, was that the researchers were unable to determine whether a patient received a balloon-expanding or self-expanding TAVR.
Dr. McCarthy reported having no financial disclosures.
HOUSTON – About 1 in 10 Medicare patients require implantation of a permanent pacemaker following transcatheter aortic valve replacement, results from a large analysis showed.
“There is conflicting evidence and some debate over permanent pacemaker placement following transcatheter aortic valve replacement – whether it has a protective or adverse effect, and how often it takes place,” study investigator Fenton H. McCarthy, MD, said in an interview at the annual meeting of the Society of Thoracic Surgeons.
One recent study found that permanent pacemaker placement within 30 days post TAVR was found in 6.7% of patients undergoing balloon-expanding or self-expanding valve implantation, and is associated with increased mortality and hospitalizations (JACC Cardiovasc Interv. 2016 Nov 14;9[21]:2189-2199).
To evaluate the relationship between permanent pacemaker implantation and long-term patient outcomes among Medicare beneficiaries undergoing TAVR, Dr. McCarthy, a cardiothoracic surgery fellow at the University of Pennsylvania, Philadelphia, and his associates used Medicare carrier claims and Medicare Provider Analysis and Review files to identify 14,305 TAVR patients between January 2011 and December 2013.
The researchers used univariate Kaplan survival estimates and multivariable models to analyze survival, readmission and risk factors for pacemaker implantation.
The mean age of the 14,305 TAVR patients studied was 83 years, and 11% received a permanent pacemaker after TAVR. Of these, 9% received the pacemaker at index hospitalization, 1% at 30 days after implant, 0.5% at 90 days after implant, and 1% at 1 year after implant. Patient age of greater than 90 years was a significant predictor of pacemaker placement, with an odds ratio of 1.7 (P less than .01).
Dr. McCarthy and his associates observed that the readmission rates for pacemaker placement and no pacemaker placement at index hospitalization were similar at 30 days (21% vs. 19%, respectively), at 90 days (33% vs. 31%) and at 1 year (43% in both groups of patients).
In addition, Kaplan Meier estimates revealed no significant difference in long-term survival for patients with pacemaker placement within 30 days of TAVR, while multivariate Cox proportional hazard modeling revealed that pacemaker placement is not a predictor of long-term mortality (hazard ratio, 1.03; P = .65).
“This was the largest study to evaluate the question of incidence and effect of permanent pacemaker in the transcatheter aortic valve replacement population in the United States,” Dr. McCarthy said. “The size of our data set and the fact that the Medicare database includes all types of patients, regardless of trial participation, study or registry, is a strength of this study. Some other studies have used different inclusion and exclusion criteria. We used broad inclusion criteria and evaluated patients from as many different centers as possible.”
A key limitation of the study, he said, was that the researchers were unable to determine whether a patient received a balloon-expanding or self-expanding TAVR.
Dr. McCarthy reported having no financial disclosures.
Key clinical point:
Major finding: Pacemaker placement is not a predictor of long-term mortality (hazard ratio, 1.03; P = .65).
Data source: A study of 14,305 Medicare beneficiaries who underwent TAVR between January 2011 and December 2013.
Disclosures: Dr. McCarthy reported having no financial disclosures.