Thoracic Surgery News (Archived)

As telemedicine gains momentum, more health providers are moving from stand-alone programs to system-wide approaches.

In a survey of 436 U.S. health care executives, physicians, nurses, hospitals, and other health professionals, 25% of respondents with a telemedicine program began with a departmental approach but are now shifting to an enterprise system, 39% had an established enterprise system, and 36% remain with a departmental basis.

The survey of health care professionals’ priorities, objectives, challenges, and telemedicine models of care was conducted between December 2016 and January 2017 for REACH Health, a telemedicine software company.

Fifty-one percent of respondents reported that telemedicine is a top priority or high priority, a decrease from last year’s survey in which 66% of respondents said so. This shift could be linked to a continuing evolution and maturation of telemedicine as more programs move from ad-hoc project status to mainstream service, according to the report.

The telemedicine features most valuable to health providers were clinical documentation, the ability to send documentation to/from the electronic medical record, and the ability to analyze consult data. For the second year, health providers rated their top three telemedicine objectives as: improving patient outcomes, improving patient convenience, and increasing patient engagement.

Overall, health providers responded that the possible repeal and replacement of the Affordable Care Act would be positive for telemedicine. Forty-one percent of respondents said that patient adoption and the use of telemedicine would increase with ACA repeal/replace and 40% of health providers said that internal adoption and use of telemedicine would rise with replacement of the health law.

Just under half (47%) said they were uncertain how health care law changes would impact telemedicine parity laws, and 45% were unsure how repeal and replace would affect Medicare and Medicaid reimbursement for telemedicine services.

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On Twitter @legal_med

As telemedicine gains momentum, more health providers are moving from stand-alone programs to system-wide approaches.

In a survey of 436 U.S. health care executives, physicians, nurses, hospitals, and other health professionals, 25% of respondents with a telemedicine program began with a departmental approach but are now shifting to an enterprise system, 39% had an established enterprise system, and 36% remain with a departmental basis.

The survey of health care professionals’ priorities, objectives, challenges, and telemedicine models of care was conducted between December 2016 and January 2017 for REACH Health, a telemedicine software company.

Fifty-one percent of respondents reported that telemedicine is a top priority or high priority, a decrease from last year’s survey in which 66% of respondents said so. This shift could be linked to a continuing evolution and maturation of telemedicine as more programs move from ad-hoc project status to mainstream service, according to the report.

The telemedicine features most valuable to health providers were clinical documentation, the ability to send documentation to/from the electronic medical record, and the ability to analyze consult data. For the second year, health providers rated their top three telemedicine objectives as: improving patient outcomes, improving patient convenience, and increasing patient engagement.

Overall, health providers responded that the possible repeal and replacement of the Affordable Care Act would be positive for telemedicine. Forty-one percent of respondents said that patient adoption and the use of telemedicine would increase with ACA repeal/replace and 40% of health providers said that internal adoption and use of telemedicine would rise with replacement of the health law.

Just under half (47%) said they were uncertain how health care law changes would impact telemedicine parity laws, and 45% were unsure how repeal and replace would affect Medicare and Medicaid reimbursement for telemedicine services.

[email protected]

On Twitter @legal_med

As telemedicine gains momentum, more health providers are moving from stand-alone programs to system-wide approaches.

In a survey of 436 U.S. health care executives, physicians, nurses, hospitals, and other health professionals, 25% of respondents with a telemedicine program began with a departmental approach but are now shifting to an enterprise system, 39% had an established enterprise system, and 36% remain with a departmental basis.

The survey of health care professionals’ priorities, objectives, challenges, and telemedicine models of care was conducted between December 2016 and January 2017 for REACH Health, a telemedicine software company.

Fifty-one percent of respondents reported that telemedicine is a top priority or high priority, a decrease from last year’s survey in which 66% of respondents said so. This shift could be linked to a continuing evolution and maturation of telemedicine as more programs move from ad-hoc project status to mainstream service, according to the report.

The telemedicine features most valuable to health providers were clinical documentation, the ability to send documentation to/from the electronic medical record, and the ability to analyze consult data. For the second year, health providers rated their top three telemedicine objectives as: improving patient outcomes, improving patient convenience, and increasing patient engagement.

Overall, health providers responded that the possible repeal and replacement of the Affordable Care Act would be positive for telemedicine. Forty-one percent of respondents said that patient adoption and the use of telemedicine would increase with ACA repeal/replace and 40% of health providers said that internal adoption and use of telemedicine would rise with replacement of the health law.

Just under half (47%) said they were uncertain how health care law changes would impact telemedicine parity laws, and 45% were unsure how repeal and replace would affect Medicare and Medicaid reimbursement for telemedicine services.

[email protected]

On Twitter @legal_med

BOSTON – Individual surgeon case volume is a significant factor in degenerative mitral valve repair rates and overall patient survival, according to a study presented at the annual meeting of the American Association for Thoracic Surgery.

The analysis, which reviewed the outcomes of 38,128 adult patients, found that higher surgeon volume of mitral cases is associated with better degenerative mitral repair rates and higher survival. In this video, Ralph Damiano Jr., MD, of Washington University, St. Louis, discusses the threshold of mitral cases that led to better repair rates and how further cardiac surgical subspecialization could improve outcomes in patients with degenerative mitral disease.

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On Twitter @legal_med

BOSTON – Individual surgeon case volume is a significant factor in degenerative mitral valve repair rates and overall patient survival, according to a study presented at the annual meeting of the American Association for Thoracic Surgery.

The analysis, which reviewed the outcomes of 38,128 adult patients, found that higher surgeon volume of mitral cases is associated with better degenerative mitral repair rates and higher survival. In this video, Ralph Damiano Jr., MD, of Washington University, St. Louis, discusses the threshold of mitral cases that led to better repair rates and how further cardiac surgical subspecialization could improve outcomes in patients with degenerative mitral disease.

[email protected]

On Twitter @legal_med

BOSTON – Individual surgeon case volume is a significant factor in degenerative mitral valve repair rates and overall patient survival, according to a study presented at the annual meeting of the American Association for Thoracic Surgery.

The analysis, which reviewed the outcomes of 38,128 adult patients, found that higher surgeon volume of mitral cases is associated with better degenerative mitral repair rates and higher survival. In this video, Ralph Damiano Jr., MD, of Washington University, St. Louis, discusses the threshold of mitral cases that led to better repair rates and how further cardiac surgical subspecialization could improve outcomes in patients with degenerative mitral disease.

[email protected]

On Twitter @legal_med

Statin therapy given as primary prevention to adults aged 65 years and older produced no benefit in any primary or secondary outcomes, according to post-hoc analysis of the ALLHAT trial published online May 22 in JAMA Internal Medicine.

Many older Americans take statins for primary cardiovascular prevention even though the evidence supporting such use is both sparse and conflicting, particularly for patients aged 75 years and older, said Benjamin H. Han, MD, of the division of geriatric medicine and palliative care, New York University, and his associates.

Creative-Family/Thinkstock

Statin therapy given as primary prevention to adults aged 65 years and older produced no benefit in any primary or secondary outcomes, according to post-hoc analysis of the ALLHAT trial published online May 22 in JAMA Internal Medicine.

Many older Americans take statins for primary cardiovascular prevention even though the evidence supporting such use is both sparse and conflicting, particularly for patients aged 75 years and older, said Benjamin H. Han, MD, of the division of geriatric medicine and palliative care, New York University, and his associates.

Creative-Family/Thinkstock

Statin therapy given as primary prevention to adults aged 65 years and older produced no benefit in any primary or secondary outcomes, according to post-hoc analysis of the ALLHAT trial published online May 22 in JAMA Internal Medicine.

Many older Americans take statins for primary cardiovascular prevention even though the evidence supporting such use is both sparse and conflicting, particularly for patients aged 75 years and older, said Benjamin H. Han, MD, of the division of geriatric medicine and palliative care, New York University, and his associates.

Creative-Family/Thinkstock

Three physician-created advanced alternative payment models have been recommended for approval by an advisory committee of the Health & Human Services department. Their path to this milestone can help guide organizations and groups who want to benefit from the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)–based Quality Payment Program on a more intense scale.

Advanced alternative payment models (APMs) involve physicians taking on two-sided risk along with Medicare in exchange for the potential for higher bonus payments for delivering higher value care to patients. Officials at the Centers for Medicare & Medicaid Services have created seven APMs (some primary care and some specialty focused), but they may not appeal to everyone. That’s where physician-created APMs come in.

• Scope of proposed PFPM (high priority)
• Quality and cost (high priority)
• Payment methodology (high priority)
• Value over volume
• Flexibility
• Ability to be evaluated
• Integration and care coordination
• Patient choice
• Patient safety
• Health information technology

While each proposal met a few of the criteria, none met all three high priority criteria and none were recommended for approval by its preliminary reviewers; however, after committee deliberation, two received provisional recommendation.

“We are recommending the two models for small-scale testing,” PTAC Vice-Chairman Elizabeth Mitchell said in an interview. “Even though we think they are very good ideas, we know that more experience and evidence is required before they may be ready.”

The two models that got the limited recommendation were

• Project Sonar, submitted by the Illinois Gastroenterology Group and SonarMD, a web-based platform that queries patients with inflammatory bowel disease monthly to determine which are in need of more hands-on care.
• APM, submitted by the American College of Surgeons, an episode-based payment model that uses claims data but expands on existing CMS value-based models by not requiring hospitalizations. It creates an episodic payment using outpatient settings, including acute and chronic care.

The COPD [chronic obstructive pulmonary disease] and Asthma Monitoring Project (CAMP), a smartphone app to remotely monitor and guide treatment of patients with asthma and chronic obstructive pulmonary disease, was not recommended. It was submitted by Pulmonary Medicine, Infectious Disease and Critical Care Consultants Medical Group of Sacremento, Calif.

PTAC has received more than 20 letters of intent from physicians and aims to hold another round of public hearings in September to determine their usefulness.

“I think it is very safe to say that our whole committee has been really gratified with the level of interest and engagement,” said Ms. Mitchell, president and CEO of Network for Regional Healthcare Improvement in Portland, Maine. The volume of applications “underscores the level of interest from the field. The entire reason PTAC was established was to get those good ideas from practicing physicians and others who are identifying better ways to deliver care but are facing barriers in the current payment system.”

She offered advice to those who are contemplating submission of a payment model.

“Really understand the criteria and review the request for proposals,” she said. “I think the committee lays out what we are looking for in terms of information, and we are hoping that it is really straight forward.”

She also stressed that successful models need to work broadly. “We are not talking about something that works for a single practice,” she said. “We are talking about models that are ready for inclusion in the whole CMS portfolio. It is helpful if there is experience to draw from that informs our deliberations, but we recognize that, in some cases, there has not been the opportunity to test these models broadly.”

Most of all, the highest priority when it comes to the models is related to quality of care and cost.

“We are not soliciting models that are essentially tweaks to fee-for-service. We are looking for changes that cannot be made without a new method of payment,” she said, adding that the models “have to either reduce cost while maintaining quality or improve quality without raising cost.”

Meeting transcripts and video are posted online and can help potential applicants see how the committee came to its recommendations.

“The committee does not deliberate on the proposals except in public,” Ms. Mitchell said. “So, those public meetings were the first time we had deliberated on any of the proposals we have considered. The preliminary review teams have discussed it [in depth], but the full committee can only deliberate in public.”

[email protected]

Three physician-created advanced alternative payment models have been recommended for approval by an advisory committee of the Health & Human Services department. Their path to this milestone can help guide organizations and groups who want to benefit from the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)–based Quality Payment Program on a more intense scale.

Advanced alternative payment models (APMs) involve physicians taking on two-sided risk along with Medicare in exchange for the potential for higher bonus payments for delivering higher value care to patients. Officials at the Centers for Medicare & Medicaid Services have created seven APMs (some primary care and some specialty focused), but they may not appeal to everyone. That’s where physician-created APMs come in.

• Scope of proposed PFPM (high priority)
• Quality and cost (high priority)
• Payment methodology (high priority)
• Value over volume
• Flexibility
• Ability to be evaluated
• Integration and care coordination
• Patient choice
• Patient safety
• Health information technology

While each proposal met a few of the criteria, none met all three high priority criteria and none were recommended for approval by its preliminary reviewers; however, after committee deliberation, two received provisional recommendation.

“We are recommending the two models for small-scale testing,” PTAC Vice-Chairman Elizabeth Mitchell said in an interview. “Even though we think they are very good ideas, we know that more experience and evidence is required before they may be ready.”

The two models that got the limited recommendation were

• Project Sonar, submitted by the Illinois Gastroenterology Group and SonarMD, a web-based platform that queries patients with inflammatory bowel disease monthly to determine which are in need of more hands-on care.
• APM, submitted by the American College of Surgeons, an episode-based payment model that uses claims data but expands on existing CMS value-based models by not requiring hospitalizations. It creates an episodic payment using outpatient settings, including acute and chronic care.

The COPD [chronic obstructive pulmonary disease] and Asthma Monitoring Project (CAMP), a smartphone app to remotely monitor and guide treatment of patients with asthma and chronic obstructive pulmonary disease, was not recommended. It was submitted by Pulmonary Medicine, Infectious Disease and Critical Care Consultants Medical Group of Sacremento, Calif.

PTAC has received more than 20 letters of intent from physicians and aims to hold another round of public hearings in September to determine their usefulness.

“I think it is very safe to say that our whole committee has been really gratified with the level of interest and engagement,” said Ms. Mitchell, president and CEO of Network for Regional Healthcare Improvement in Portland, Maine. The volume of applications “underscores the level of interest from the field. The entire reason PTAC was established was to get those good ideas from practicing physicians and others who are identifying better ways to deliver care but are facing barriers in the current payment system.”

She offered advice to those who are contemplating submission of a payment model.

“Really understand the criteria and review the request for proposals,” she said. “I think the committee lays out what we are looking for in terms of information, and we are hoping that it is really straight forward.”

She also stressed that successful models need to work broadly. “We are not talking about something that works for a single practice,” she said. “We are talking about models that are ready for inclusion in the whole CMS portfolio. It is helpful if there is experience to draw from that informs our deliberations, but we recognize that, in some cases, there has not been the opportunity to test these models broadly.”

Most of all, the highest priority when it comes to the models is related to quality of care and cost.

“We are not soliciting models that are essentially tweaks to fee-for-service. We are looking for changes that cannot be made without a new method of payment,” she said, adding that the models “have to either reduce cost while maintaining quality or improve quality without raising cost.”

Meeting transcripts and video are posted online and can help potential applicants see how the committee came to its recommendations.

“The committee does not deliberate on the proposals except in public,” Ms. Mitchell said. “So, those public meetings were the first time we had deliberated on any of the proposals we have considered. The preliminary review teams have discussed it [in depth], but the full committee can only deliberate in public.”

[email protected]

Three physician-created advanced alternative payment models have been recommended for approval by an advisory committee of the Health & Human Services department. Their path to this milestone can help guide organizations and groups who want to benefit from the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)–based Quality Payment Program on a more intense scale.

Advanced alternative payment models (APMs) involve physicians taking on two-sided risk along with Medicare in exchange for the potential for higher bonus payments for delivering higher value care to patients. Officials at the Centers for Medicare & Medicaid Services have created seven APMs (some primary care and some specialty focused), but they may not appeal to everyone. That’s where physician-created APMs come in.

• Scope of proposed PFPM (high priority)
• Quality and cost (high priority)
• Payment methodology (high priority)
• Value over volume
• Flexibility
• Ability to be evaluated
• Integration and care coordination
• Patient choice
• Patient safety
• Health information technology

While each proposal met a few of the criteria, none met all three high priority criteria and none were recommended for approval by its preliminary reviewers; however, after committee deliberation, two received provisional recommendation.

“We are recommending the two models for small-scale testing,” PTAC Vice-Chairman Elizabeth Mitchell said in an interview. “Even though we think they are very good ideas, we know that more experience and evidence is required before they may be ready.”

The two models that got the limited recommendation were

• Project Sonar, submitted by the Illinois Gastroenterology Group and SonarMD, a web-based platform that queries patients with inflammatory bowel disease monthly to determine which are in need of more hands-on care.
• APM, submitted by the American College of Surgeons, an episode-based payment model that uses claims data but expands on existing CMS value-based models by not requiring hospitalizations. It creates an episodic payment using outpatient settings, including acute and chronic care.

The COPD [chronic obstructive pulmonary disease] and Asthma Monitoring Project (CAMP), a smartphone app to remotely monitor and guide treatment of patients with asthma and chronic obstructive pulmonary disease, was not recommended. It was submitted by Pulmonary Medicine, Infectious Disease and Critical Care Consultants Medical Group of Sacremento, Calif.

PTAC has received more than 20 letters of intent from physicians and aims to hold another round of public hearings in September to determine their usefulness.

“I think it is very safe to say that our whole committee has been really gratified with the level of interest and engagement,” said Ms. Mitchell, president and CEO of Network for Regional Healthcare Improvement in Portland, Maine. The volume of applications “underscores the level of interest from the field. The entire reason PTAC was established was to get those good ideas from practicing physicians and others who are identifying better ways to deliver care but are facing barriers in the current payment system.”

She offered advice to those who are contemplating submission of a payment model.

“Really understand the criteria and review the request for proposals,” she said. “I think the committee lays out what we are looking for in terms of information, and we are hoping that it is really straight forward.”

She also stressed that successful models need to work broadly. “We are not talking about something that works for a single practice,” she said. “We are talking about models that are ready for inclusion in the whole CMS portfolio. It is helpful if there is experience to draw from that informs our deliberations, but we recognize that, in some cases, there has not been the opportunity to test these models broadly.”

Most of all, the highest priority when it comes to the models is related to quality of care and cost.

“We are not soliciting models that are essentially tweaks to fee-for-service. We are looking for changes that cannot be made without a new method of payment,” she said, adding that the models “have to either reduce cost while maintaining quality or improve quality without raising cost.”

Meeting transcripts and video are posted online and can help potential applicants see how the committee came to its recommendations.

“The committee does not deliberate on the proposals except in public,” Ms. Mitchell said. “So, those public meetings were the first time we had deliberated on any of the proposals we have considered. The preliminary review teams have discussed it [in depth], but the full committee can only deliberate in public.”

[email protected]

PARIS – The investigational mechanically expandable Lotus valve system for transcatheter aortic valve replacement proved significantly more effective than the commercially available CoreValve platform in patients with severe aortic stenosis deemed at high or extreme surgical risk in the randomized pivotal phase III REPRISE III trial, Ted E. Feldman, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

The 1-year composite primary effectiveness endpoint comprised of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak (PVL) occurred in 17% of patients randomized to the Lotus transcatheter aortic valve replacement (TAVR) device, compared with 29% of those in the CoreValve group, said Dr. Feldman, director of the cardiac catheterization laboratory at NorthShore University HealthSystem in Evanston, Ill.

Bruce Jancin/Frontline Medical News

PARIS – The investigational mechanically expandable Lotus valve system for transcatheter aortic valve replacement proved significantly more effective than the commercially available CoreValve platform in patients with severe aortic stenosis deemed at high or extreme surgical risk in the randomized pivotal phase III REPRISE III trial, Ted E. Feldman, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

The 1-year composite primary effectiveness endpoint comprised of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak (PVL) occurred in 17% of patients randomized to the Lotus transcatheter aortic valve replacement (TAVR) device, compared with 29% of those in the CoreValve group, said Dr. Feldman, director of the cardiac catheterization laboratory at NorthShore University HealthSystem in Evanston, Ill.

Bruce Jancin/Frontline Medical News

PARIS – The investigational mechanically expandable Lotus valve system for transcatheter aortic valve replacement proved significantly more effective than the commercially available CoreValve platform in patients with severe aortic stenosis deemed at high or extreme surgical risk in the randomized pivotal phase III REPRISE III trial, Ted E. Feldman, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

The 1-year composite primary effectiveness endpoint comprised of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak (PVL) occurred in 17% of patients randomized to the Lotus transcatheter aortic valve replacement (TAVR) device, compared with 29% of those in the CoreValve group, said Dr. Feldman, director of the cardiac catheterization laboratory at NorthShore University HealthSystem in Evanston, Ill.

Bruce Jancin/Frontline Medical News

Reduced opioid prescribing did not correlate with inpatient pain management scores, a study has shown.

The Centers for Medicare & Medicaid Services announced recently that, as of 2018, pain management will no longer be rated in the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey, citing concerns that patient satisfaction surveys given at the time of postoperative discharge incentivizes clinicians to over-prescribe pain medication. Surgical patients are key contributors to HCAHPS scores, and opioids account for almost 40% of surgical prescriptions, according to the study.

A new study throws some shade on the CMS decision to delete pain management from the HCAHPS survey.

Ingram/thinkstock

Dr. Brummett disclosed relationships with Tonix and Neuros Medical. He also holds a patent for peripheral perineural dexmedetomidine. Mr. Syrjamaki and Dr. Dupree received support from Blue Cross Blue Shield of Michigan for their respective roles in the Michigan Value Collaborative. Dr. Waljee is an unpaid consultant for 3MHealth.

[email protected]

On Twitter @whitneymcknight

Reduced opioid prescribing did not correlate with inpatient pain management scores, a study has shown.

The Centers for Medicare & Medicaid Services announced recently that, as of 2018, pain management will no longer be rated in the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey, citing concerns that patient satisfaction surveys given at the time of postoperative discharge incentivizes clinicians to over-prescribe pain medication. Surgical patients are key contributors to HCAHPS scores, and opioids account for almost 40% of surgical prescriptions, according to the study.

A new study throws some shade on the CMS decision to delete pain management from the HCAHPS survey.

Ingram/thinkstock

Dr. Brummett disclosed relationships with Tonix and Neuros Medical. He also holds a patent for peripheral perineural dexmedetomidine. Mr. Syrjamaki and Dr. Dupree received support from Blue Cross Blue Shield of Michigan for their respective roles in the Michigan Value Collaborative. Dr. Waljee is an unpaid consultant for 3MHealth.

[email protected]

On Twitter @whitneymcknight

Reduced opioid prescribing did not correlate with inpatient pain management scores, a study has shown.

The Centers for Medicare & Medicaid Services announced recently that, as of 2018, pain management will no longer be rated in the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey, citing concerns that patient satisfaction surveys given at the time of postoperative discharge incentivizes clinicians to over-prescribe pain medication. Surgical patients are key contributors to HCAHPS scores, and opioids account for almost 40% of surgical prescriptions, according to the study.

A new study throws some shade on the CMS decision to delete pain management from the HCAHPS survey.

Ingram/thinkstock

Dr. Brummett disclosed relationships with Tonix and Neuros Medical. He also holds a patent for peripheral perineural dexmedetomidine. Mr. Syrjamaki and Dr. Dupree received support from Blue Cross Blue Shield of Michigan for their respective roles in the Michigan Value Collaborative. Dr. Waljee is an unpaid consultant for 3MHealth.

[email protected]

On Twitter @whitneymcknight

The targeted agent gefitinib is superior to the standard of care chemotherapy for treating resected early non–small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) activating mutation, finds the phase III randomized Chinese ADJUVANT trial.

Gefitinib, an oral tyrosine kinase inhibitor that targets the EGFR kinase among others, is already approved by the Food and Drug Administration for treatment of locally advanced or metastatic disease having mutations in the gene for this receptor.

Trial results reported in a presscast leading up to the annual meeting of the American Society of Clinical Oncology showed that compared with vinorelbine and cisplatin combination chemotherapy, 2 years of gefitinib prolonged the time to recurrence or death by more than 10 months, reducing risk of these events by a significant 40%. Gefitinib also was better tolerated: The rate of grade 3 or worse adverse events with the targeted agent was one-fourth that seen with the chemotherapy.

“Targeted therapy can delay recurrence of intermediate-stage lung cancer after surgery. Two-year treatment duration of gefitinib is efficacious and tolerated well,” said lead study author Yi-Long Wu, MD, director of the Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangzhou, China. “Adjuvant gefitinib should be considered as an important option for stage II to IIIA lung cancer patients with an activating EGFR mutation.”

Clinical implications

The improved disease-free survival seen with gefitinib in ADJUVANT is “encouraging,” according to ASCO President-Elect Bruce E. Johnson, MD, chief clinical research officer and an Institute Physician at the Dana-Farber Cancer Institute in Boston.

Longer follow-up will be needed to obtain a full picture as the horizon for events in the adjuvant setting is more on the order of years, and the disease-free survival curves began converging over time, he noted. “We will ultimately be interested in seeing whether this actually prolongs survival in a longer follow-up study, which Dr. Wu’s group is planning to do.

“I haven’t changed my approach yet for the patients with EGFR-mutant lung cancer,” Dr. Johnson concluded. “But I will be following this [trial] very closely to see what happens to the survival.”

The new data from ADJUVANT will likely have several effects on the clinical management of NSCLC, according to presscast moderator and ASCO Chief Medical Officer Richard L. Schilsky, MD.

“I suspect that many doctors will begin testing these lung cancer tumors right after surgery, to see if they actually have an EGFR mutation. That is not currently standard of care in the U.S.; typically the testing doesn’t take place until the cancer recurs or becomes metastatic,” he said. “So that way, doctors and patients will know whether or not treatment with an EGFR inhibitor is even an option.

“If it is an option, then many factors will likely come into play, and most importantly we will be waiting for the survival data,” said Dr. Schilsky, professor emeritus at the University of Chicago. Another consideration is that the trial compared 12 weeks of chemotherapy with 2 years of continuous gefitinib therapy, the latter of which requires a long-term commitment to adherence by patients and carries much greater cost.

“At the end of the day, I think that once the survival data is known in particular, doctors and patients are going to have to have very thoughtful discussions about what is the magnitude of the survival benefit; what is the burden on the patient to take either cytotoxic chemotherapy for 12 weeks or 2 years of an oral treatment, which, while it is less toxic, is not without toxicity; and what’s the financial burden of that treatment choice going to be for the patient,” he concluded.

Study details

Eligibility for the ADJUVANT trial required completely resected pathological stage II-IIIA (N1-N2) NSCLC with an EGFR-activating mutation. In all, 220 patients were randomized evenly to receive gefitinib (Iressa) once daily for 24 months or vinorelbine plus cisplatin every 3 weeks for 4 cycles.

Results showed that median disease-free survival – the trial’s primary endpoint—was 28.7 months with gefitinib compared with 18.0 months with chemotherapy (hazard ratio, 0.60; P = .005), Dr. Wu reported in the presscast. Corresponding 3-year disease-free survival rates were 34% and 27%.

The rate of grade 3 or worse adverse events was 12.3% in the gefitinib group, compared with 48.3% in the chemotherapy group. Most types of events were less common with the tyrosine kinase inhibitor, with the exception of rash, diarrhea, and elevation of liver enzymes.

Dr. Wu disclosed ties with AstraZeneca, Roche, Merck, Boehringer Ingelheim; Lilly, Pierre Fabre, Pfizer, and Sanofi. The Chinese Thoracic Oncology Group and AstraZeneca Chin funded the trial.

The targeted agent gefitinib is superior to the standard of care chemotherapy for treating resected early non–small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) activating mutation, finds the phase III randomized Chinese ADJUVANT trial.

Gefitinib, an oral tyrosine kinase inhibitor that targets the EGFR kinase among others, is already approved by the Food and Drug Administration for treatment of locally advanced or metastatic disease having mutations in the gene for this receptor.

Trial results reported in a presscast leading up to the annual meeting of the American Society of Clinical Oncology showed that compared with vinorelbine and cisplatin combination chemotherapy, 2 years of gefitinib prolonged the time to recurrence or death by more than 10 months, reducing risk of these events by a significant 40%. Gefitinib also was better tolerated: The rate of grade 3 or worse adverse events with the targeted agent was one-fourth that seen with the chemotherapy.

“Targeted therapy can delay recurrence of intermediate-stage lung cancer after surgery. Two-year treatment duration of gefitinib is efficacious and tolerated well,” said lead study author Yi-Long Wu, MD, director of the Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangzhou, China. “Adjuvant gefitinib should be considered as an important option for stage II to IIIA lung cancer patients with an activating EGFR mutation.”

Clinical implications

The improved disease-free survival seen with gefitinib in ADJUVANT is “encouraging,” according to ASCO President-Elect Bruce E. Johnson, MD, chief clinical research officer and an Institute Physician at the Dana-Farber Cancer Institute in Boston.

Longer follow-up will be needed to obtain a full picture as the horizon for events in the adjuvant setting is more on the order of years, and the disease-free survival curves began converging over time, he noted. “We will ultimately be interested in seeing whether this actually prolongs survival in a longer follow-up study, which Dr. Wu’s group is planning to do.

“I haven’t changed my approach yet for the patients with EGFR-mutant lung cancer,” Dr. Johnson concluded. “But I will be following this [trial] very closely to see what happens to the survival.”

The new data from ADJUVANT will likely have several effects on the clinical management of NSCLC, according to presscast moderator and ASCO Chief Medical Officer Richard L. Schilsky, MD.

“I suspect that many doctors will begin testing these lung cancer tumors right after surgery, to see if they actually have an EGFR mutation. That is not currently standard of care in the U.S.; typically the testing doesn’t take place until the cancer recurs or becomes metastatic,” he said. “So that way, doctors and patients will know whether or not treatment with an EGFR inhibitor is even an option.

“If it is an option, then many factors will likely come into play, and most importantly we will be waiting for the survival data,” said Dr. Schilsky, professor emeritus at the University of Chicago. Another consideration is that the trial compared 12 weeks of chemotherapy with 2 years of continuous gefitinib therapy, the latter of which requires a long-term commitment to adherence by patients and carries much greater cost.

“At the end of the day, I think that once the survival data is known in particular, doctors and patients are going to have to have very thoughtful discussions about what is the magnitude of the survival benefit; what is the burden on the patient to take either cytotoxic chemotherapy for 12 weeks or 2 years of an oral treatment, which, while it is less toxic, is not without toxicity; and what’s the financial burden of that treatment choice going to be for the patient,” he concluded.

Study details

Eligibility for the ADJUVANT trial required completely resected pathological stage II-IIIA (N1-N2) NSCLC with an EGFR-activating mutation. In all, 220 patients were randomized evenly to receive gefitinib (Iressa) once daily for 24 months or vinorelbine plus cisplatin every 3 weeks for 4 cycles.

Results showed that median disease-free survival – the trial’s primary endpoint—was 28.7 months with gefitinib compared with 18.0 months with chemotherapy (hazard ratio, 0.60; P = .005), Dr. Wu reported in the presscast. Corresponding 3-year disease-free survival rates were 34% and 27%.

The rate of grade 3 or worse adverse events was 12.3% in the gefitinib group, compared with 48.3% in the chemotherapy group. Most types of events were less common with the tyrosine kinase inhibitor, with the exception of rash, diarrhea, and elevation of liver enzymes.

Dr. Wu disclosed ties with AstraZeneca, Roche, Merck, Boehringer Ingelheim; Lilly, Pierre Fabre, Pfizer, and Sanofi. The Chinese Thoracic Oncology Group and AstraZeneca Chin funded the trial.

The targeted agent gefitinib is superior to the standard of care chemotherapy for treating resected early non–small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) activating mutation, finds the phase III randomized Chinese ADJUVANT trial.

Gefitinib, an oral tyrosine kinase inhibitor that targets the EGFR kinase among others, is already approved by the Food and Drug Administration for treatment of locally advanced or metastatic disease having mutations in the gene for this receptor.

Trial results reported in a presscast leading up to the annual meeting of the American Society of Clinical Oncology showed that compared with vinorelbine and cisplatin combination chemotherapy, 2 years of gefitinib prolonged the time to recurrence or death by more than 10 months, reducing risk of these events by a significant 40%. Gefitinib also was better tolerated: The rate of grade 3 or worse adverse events with the targeted agent was one-fourth that seen with the chemotherapy.

“Targeted therapy can delay recurrence of intermediate-stage lung cancer after surgery. Two-year treatment duration of gefitinib is efficacious and tolerated well,” said lead study author Yi-Long Wu, MD, director of the Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangzhou, China. “Adjuvant gefitinib should be considered as an important option for stage II to IIIA lung cancer patients with an activating EGFR mutation.”

Clinical implications

The improved disease-free survival seen with gefitinib in ADJUVANT is “encouraging,” according to ASCO President-Elect Bruce E. Johnson, MD, chief clinical research officer and an Institute Physician at the Dana-Farber Cancer Institute in Boston.

Longer follow-up will be needed to obtain a full picture as the horizon for events in the adjuvant setting is more on the order of years, and the disease-free survival curves began converging over time, he noted. “We will ultimately be interested in seeing whether this actually prolongs survival in a longer follow-up study, which Dr. Wu’s group is planning to do.

“I haven’t changed my approach yet for the patients with EGFR-mutant lung cancer,” Dr. Johnson concluded. “But I will be following this [trial] very closely to see what happens to the survival.”

The new data from ADJUVANT will likely have several effects on the clinical management of NSCLC, according to presscast moderator and ASCO Chief Medical Officer Richard L. Schilsky, MD.

“I suspect that many doctors will begin testing these lung cancer tumors right after surgery, to see if they actually have an EGFR mutation. That is not currently standard of care in the U.S.; typically the testing doesn’t take place until the cancer recurs or becomes metastatic,” he said. “So that way, doctors and patients will know whether or not treatment with an EGFR inhibitor is even an option.

“If it is an option, then many factors will likely come into play, and most importantly we will be waiting for the survival data,” said Dr. Schilsky, professor emeritus at the University of Chicago. Another consideration is that the trial compared 12 weeks of chemotherapy with 2 years of continuous gefitinib therapy, the latter of which requires a long-term commitment to adherence by patients and carries much greater cost.

“At the end of the day, I think that once the survival data is known in particular, doctors and patients are going to have to have very thoughtful discussions about what is the magnitude of the survival benefit; what is the burden on the patient to take either cytotoxic chemotherapy for 12 weeks or 2 years of an oral treatment, which, while it is less toxic, is not without toxicity; and what’s the financial burden of that treatment choice going to be for the patient,” he concluded.

Study details

Eligibility for the ADJUVANT trial required completely resected pathological stage II-IIIA (N1-N2) NSCLC with an EGFR-activating mutation. In all, 220 patients were randomized evenly to receive gefitinib (Iressa) once daily for 24 months or vinorelbine plus cisplatin every 3 weeks for 4 cycles.

Results showed that median disease-free survival – the trial’s primary endpoint—was 28.7 months with gefitinib compared with 18.0 months with chemotherapy (hazard ratio, 0.60; P = .005), Dr. Wu reported in the presscast. Corresponding 3-year disease-free survival rates were 34% and 27%.

The rate of grade 3 or worse adverse events was 12.3% in the gefitinib group, compared with 48.3% in the chemotherapy group. Most types of events were less common with the tyrosine kinase inhibitor, with the exception of rash, diarrhea, and elevation of liver enzymes.

Dr. Wu disclosed ties with AstraZeneca, Roche, Merck, Boehringer Ingelheim; Lilly, Pierre Fabre, Pfizer, and Sanofi. The Chinese Thoracic Oncology Group and AstraZeneca Chin funded the trial.

The FDA has authorized a medical device to treat infants up to age 1 year for esophageal atresia, called the Flourish Pediatric Esophageal Atresia Anastomosis.

The device uses magnets attached to two catheters to pull the upper and lower esophagus together, closing the gap for several days until a connection is formed. The catheters are then removed, and the infant can begin feeding via mouth.

[email protected]

The FDA has authorized a medical device to treat infants up to age 1 year for esophageal atresia, called the Flourish Pediatric Esophageal Atresia Anastomosis.

The device uses magnets attached to two catheters to pull the upper and lower esophagus together, closing the gap for several days until a connection is formed. The catheters are then removed, and the infant can begin feeding via mouth.

[email protected]

The FDA has authorized a medical device to treat infants up to age 1 year for esophageal atresia, called the Flourish Pediatric Esophageal Atresia Anastomosis.

The device uses magnets attached to two catheters to pull the upper and lower esophagus together, closing the gap for several days until a connection is formed. The catheters are then removed, and the infant can begin feeding via mouth.

[email protected]

Implementation of the Affordable Care Act (ACA) has been associated with a shift toward earlier stage at diagnosis for common screenable cancers, finds an analysis of nearly 273,000 patients reported in a presscast leading up to the annual meeting of the American Society of Clinical Oncology.

“Extensive evidence has shown that people without insurance are more likely to be diagnosed at later stage, especially for the cancers that can be detected earlier through screening or symptoms,” said lead study author Xuesong Han, PhD, strategic director of health policy and health care delivery research at the American Cancer Society in Atlanta. “In 2014, two major components of the Affordable Care Act – Medicaid expansion and marketplace exchange – were implemented. As a result, insurance coverage has substantially increased for nonelderly Americans.”

Study findings showed that, for four of five screenable cancers – breast and cervical cancer in women and lung and colorectal cancer in both sexes combined – the proportion of cancers that were stage I at diagnosis, and hence most curable, increased by an absolute 1% or so after the ACA was implemented. Prostate cancer was the outlier: the value for this malignancy decreased by 1%.

“The increases for the first four cancers were consistent with our hypothesis, with more people gaining insurance and access to screening services or access to physicians to detect early symptoms,” Dr. Han summarized. “But what about prostate cancer? We think [that pattern] may reflect the recent USPSTF recommendations against routine prostate cancer screening.”

“We think that this is an important study,” commented ASCO president-elect Bruce E. Johnson, MD, who is also chief clinical research officer and an institute physician at the Dana-Farber Cancer Institute in Boston. “Obviously, the changes are not enormous; they are not dramatic. But … because the uptake of screening is relatively slow, this is certainly consistent with the idea that, by doing additional screening, you can potentially find more stage I patients, and, the earlier the stage, the more likely one is to be cured.”

“The other important thing is that ASCO strongly supports the relative ease of access to screening capabilities, and that’s one of the characteristics of the Affordable Care Act, that most of the cancer screening is covered,” he further stated. “Whatever form our health care takes over the next several years, we advocate for patients to have early access to screening, which can identify cancers at an earlier stage in their more curable forms.”
 

Study details

For the study, the investigators used the National Cancer Database – which captures 70% of newly diagnosed cases in the United States – to identify patients younger than 65 who were eligible for cancer screening and who received a diagnosis of any of the five screenable cancers in 2013 or 2014. They compared stage distribution before ACA implementation (first nine months of 2013) and afterward (last nine months of 2014).

Analyses were based on data from 121,402 female breast cancer patients aged 40-64 years, 39,418 colorectal cancer patients aged 50-64 years, 11,190 cervical cancer patients aged 21-64 years, 59,210 prostate cancer patients aged 50-64 years, and 41,436 lung cancer patients aged 55-64 years.

Results showed that the proportion of cancers that were stage I at diagnosis increased after ACA implementation from 47.8% to 48.9% for breast cancer (adjusted prevalence ratio, 1.02) and from 47.3% to 48.8% for cervical cancer (APR, 1.02) in women, and from 16.6% to 17.7% for lung cancer (APR, 1.07) and from 22.8% to 23.7% for colorectal cancer (APR, 1.04) in men and women combined, Dr. Han reported.

Prostate cancer was the exception, with the proportion of cases that were stage I at diagnosis falling from 18.5% to 17.2% (APR, 0.93).

In a stratified analysis, the significant downshift in lung and colorectal cancer stage were seen only in states that had actually adopted the Medicaid expansion component of the ACA, which covers low-income individuals, according to Dr. Han. The downshift in female breast cancer stage and upshift in prostate cancer stage occurred regardless of whether states had done so.

Implementation of the Affordable Care Act (ACA) has been associated with a shift toward earlier stage at diagnosis for common screenable cancers, finds an analysis of nearly 273,000 patients reported in a presscast leading up to the annual meeting of the American Society of Clinical Oncology.

“Extensive evidence has shown that people without insurance are more likely to be diagnosed at later stage, especially for the cancers that can be detected earlier through screening or symptoms,” said lead study author Xuesong Han, PhD, strategic director of health policy and health care delivery research at the American Cancer Society in Atlanta. “In 2014, two major components of the Affordable Care Act – Medicaid expansion and marketplace exchange – were implemented. As a result, insurance coverage has substantially increased for nonelderly Americans.”

Study findings showed that, for four of five screenable cancers – breast and cervical cancer in women and lung and colorectal cancer in both sexes combined – the proportion of cancers that were stage I at diagnosis, and hence most curable, increased by an absolute 1% or so after the ACA was implemented. Prostate cancer was the outlier: the value for this malignancy decreased by 1%.

“The increases for the first four cancers were consistent with our hypothesis, with more people gaining insurance and access to screening services or access to physicians to detect early symptoms,” Dr. Han summarized. “But what about prostate cancer? We think [that pattern] may reflect the recent USPSTF recommendations against routine prostate cancer screening.”

“We think that this is an important study,” commented ASCO president-elect Bruce E. Johnson, MD, who is also chief clinical research officer and an institute physician at the Dana-Farber Cancer Institute in Boston. “Obviously, the changes are not enormous; they are not dramatic. But … because the uptake of screening is relatively slow, this is certainly consistent with the idea that, by doing additional screening, you can potentially find more stage I patients, and, the earlier the stage, the more likely one is to be cured.”

“The other important thing is that ASCO strongly supports the relative ease of access to screening capabilities, and that’s one of the characteristics of the Affordable Care Act, that most of the cancer screening is covered,” he further stated. “Whatever form our health care takes over the next several years, we advocate for patients to have early access to screening, which can identify cancers at an earlier stage in their more curable forms.”
 

Study details

For the study, the investigators used the National Cancer Database – which captures 70% of newly diagnosed cases in the United States – to identify patients younger than 65 who were eligible for cancer screening and who received a diagnosis of any of the five screenable cancers in 2013 or 2014. They compared stage distribution before ACA implementation (first nine months of 2013) and afterward (last nine months of 2014).

Analyses were based on data from 121,402 female breast cancer patients aged 40-64 years, 39,418 colorectal cancer patients aged 50-64 years, 11,190 cervical cancer patients aged 21-64 years, 59,210 prostate cancer patients aged 50-64 years, and 41,436 lung cancer patients aged 55-64 years.

Results showed that the proportion of cancers that were stage I at diagnosis increased after ACA implementation from 47.8% to 48.9% for breast cancer (adjusted prevalence ratio, 1.02) and from 47.3% to 48.8% for cervical cancer (APR, 1.02) in women, and from 16.6% to 17.7% for lung cancer (APR, 1.07) and from 22.8% to 23.7% for colorectal cancer (APR, 1.04) in men and women combined, Dr. Han reported.

Prostate cancer was the exception, with the proportion of cases that were stage I at diagnosis falling from 18.5% to 17.2% (APR, 0.93).

In a stratified analysis, the significant downshift in lung and colorectal cancer stage were seen only in states that had actually adopted the Medicaid expansion component of the ACA, which covers low-income individuals, according to Dr. Han. The downshift in female breast cancer stage and upshift in prostate cancer stage occurred regardless of whether states had done so.

Implementation of the Affordable Care Act (ACA) has been associated with a shift toward earlier stage at diagnosis for common screenable cancers, finds an analysis of nearly 273,000 patients reported in a presscast leading up to the annual meeting of the American Society of Clinical Oncology.

“Extensive evidence has shown that people without insurance are more likely to be diagnosed at later stage, especially for the cancers that can be detected earlier through screening or symptoms,” said lead study author Xuesong Han, PhD, strategic director of health policy and health care delivery research at the American Cancer Society in Atlanta. “In 2014, two major components of the Affordable Care Act – Medicaid expansion and marketplace exchange – were implemented. As a result, insurance coverage has substantially increased for nonelderly Americans.”

Study findings showed that, for four of five screenable cancers – breast and cervical cancer in women and lung and colorectal cancer in both sexes combined – the proportion of cancers that were stage I at diagnosis, and hence most curable, increased by an absolute 1% or so after the ACA was implemented. Prostate cancer was the outlier: the value for this malignancy decreased by 1%.

“The increases for the first four cancers were consistent with our hypothesis, with more people gaining insurance and access to screening services or access to physicians to detect early symptoms,” Dr. Han summarized. “But what about prostate cancer? We think [that pattern] may reflect the recent USPSTF recommendations against routine prostate cancer screening.”

“We think that this is an important study,” commented ASCO president-elect Bruce E. Johnson, MD, who is also chief clinical research officer and an institute physician at the Dana-Farber Cancer Institute in Boston. “Obviously, the changes are not enormous; they are not dramatic. But … because the uptake of screening is relatively slow, this is certainly consistent with the idea that, by doing additional screening, you can potentially find more stage I patients, and, the earlier the stage, the more likely one is to be cured.”

“The other important thing is that ASCO strongly supports the relative ease of access to screening capabilities, and that’s one of the characteristics of the Affordable Care Act, that most of the cancer screening is covered,” he further stated. “Whatever form our health care takes over the next several years, we advocate for patients to have early access to screening, which can identify cancers at an earlier stage in their more curable forms.”
 

Study details

For the study, the investigators used the National Cancer Database – which captures 70% of newly diagnosed cases in the United States – to identify patients younger than 65 who were eligible for cancer screening and who received a diagnosis of any of the five screenable cancers in 2013 or 2014. They compared stage distribution before ACA implementation (first nine months of 2013) and afterward (last nine months of 2014).

Analyses were based on data from 121,402 female breast cancer patients aged 40-64 years, 39,418 colorectal cancer patients aged 50-64 years, 11,190 cervical cancer patients aged 21-64 years, 59,210 prostate cancer patients aged 50-64 years, and 41,436 lung cancer patients aged 55-64 years.

Results showed that the proportion of cancers that were stage I at diagnosis increased after ACA implementation from 47.8% to 48.9% for breast cancer (adjusted prevalence ratio, 1.02) and from 47.3% to 48.8% for cervical cancer (APR, 1.02) in women, and from 16.6% to 17.7% for lung cancer (APR, 1.07) and from 22.8% to 23.7% for colorectal cancer (APR, 1.04) in men and women combined, Dr. Han reported.

Prostate cancer was the exception, with the proportion of cases that were stage I at diagnosis falling from 18.5% to 17.2% (APR, 0.93).

In a stratified analysis, the significant downshift in lung and colorectal cancer stage were seen only in states that had actually adopted the Medicaid expansion component of the ACA, which covers low-income individuals, according to Dr. Han. The downshift in female breast cancer stage and upshift in prostate cancer stage occurred regardless of whether states had done so.

BOSTON – A new study highlights the success, safety, and effectiveness of a new sutureless aortic valve device in patients with severe symptomatic aortic valve stenosis (AS).

The findings, reported at the annual meeting of the American Association for Thoracic Surgery, were based on a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption (IDE) that aimed to assess the safety and efficacy of a new bovine pericardial sutureless aortic valve in patients with severe AS undergoing aortic valve replacement with or without concomitant procedures. In this video interview, Michael Borger, MD, explains how the study was conducted and what the findings mean for future use of the sutureless aortic valve device.

[email protected]

On Twitter @legal_med

BOSTON – A new study highlights the success, safety, and effectiveness of a new sutureless aortic valve device in patients with severe symptomatic aortic valve stenosis (AS).

The findings, reported at the annual meeting of the American Association for Thoracic Surgery, were based on a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption (IDE) that aimed to assess the safety and efficacy of a new bovine pericardial sutureless aortic valve in patients with severe AS undergoing aortic valve replacement with or without concomitant procedures. In this video interview, Michael Borger, MD, explains how the study was conducted and what the findings mean for future use of the sutureless aortic valve device.

[email protected]

On Twitter @legal_med

BOSTON – A new study highlights the success, safety, and effectiveness of a new sutureless aortic valve device in patients with severe symptomatic aortic valve stenosis (AS).

The findings, reported at the annual meeting of the American Association for Thoracic Surgery, were based on a prospective, single-arm clinical trial approved under a Food and Drug Administration Investigational Device Exemption (IDE) that aimed to assess the safety and efficacy of a new bovine pericardial sutureless aortic valve in patients with severe AS undergoing aortic valve replacement with or without concomitant procedures. In this video interview, Michael Borger, MD, explains how the study was conducted and what the findings mean for future use of the sutureless aortic valve device.

[email protected]

On Twitter @legal_med