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Red flag raised on CMS indication–based formulary design policy
Physician groups are expressing concerns regarding a new policy that will allow indication-based formulary design in the Medicare Part D prescription drug benefit.
The Centers for Medicare & Medicaid Services announced the new policy in an Aug. 29 memo to Part D plan sponsors.
According to a fact sheet issued by CMS on the same day, indication-based formulary design “is a formulary management tool that allows health plans to tailor on-formulary coverage of drugs predicated on specific indications.”
Current Part D policy requires plan sponsors to cover all Food and Drug Administration–approved indications for each drug that is on a plan formulary. Sponsors can begin to implement the new indication-based formulary design policy for plans issued in 2020.
The memo notes that if a Part D plan sponsor chooses to opt into this policy, “it must ensure that there is another therapeutically similar drug on formulary for the nonformulary indication. For example, if a tumor necrosis factor (TNF) blocker is FDA-approved for both Crohn’s disease and plaque psoriasis, but the Part D plan will include it on formulary for plaque psoriasis only, the plan must ensure that there is another TNF blocker on formulary that will be covered for Crohn’s disease.”
Beneficiaries can use the exceptions process to get coverage for a drug that has an indication not on the formulary.
“By allowing Medicare’s prescription drug plans to cover the best drug for each patient condition, plans will have more negotiating power with drug companies, which will result in lower prices for Medicare beneficiaries,” CMS Administrator Seema Verma said in a statement.
However, physician groups see this more as something that could create access issues for patients.
The “proposed changes will exacerbate many of the access issues patients currently face with plan usage of existing utilization management practices, such as step therapy,” the American College of Rheumatology said in a statement. “Unlike step therapy, which often delays effective treatments, this proposal would go even further and allow plans to remove therapies from the formulary altogether, leaving patients completely unable to access treatments that doctors and patients choose together. ... We also have concerns on what this would mean for work being done on compendia inclusion to secure off-label drug coverage if plans don’t have to cover all approved FDA-approved indications.”
The ACR called on CMS to clarify the exception process to make sure patients have access to their needed drugs.
The American Medical Association agreed.
“Under the plan, Medicare patients will face increased challenges as they navigate health plans to make sure that their needed drug is on their selected formulary, which can change based on what health conditions they have,” AMA President Barbara McAneny, MD, said in a statement. “While the CMS notice included a statement that plans had to include information addressing indication-based formularies in materials provided to prospective enrollees, that is not much help to patients who are not sophisticated in how formularies work.”
Dr. McAneny added that it will be even more difficult for physicians who are working with patients to get them on the best medicines covered by the patient’s formulary.
“Physicians already lack ready access to accurate formulary information – preferred/tier status, on/off formulary, PA [prior authorization] and step therapy requirements – at the point of care in their EHRs,” she said. “These transparency problems will expand by an order of magnitude by the complications this change introduces.”
She also noted that it could be difficult for patients who have multiple chronic conditions to find a drug plan that covers the range of their medications, although CMS said the move is expected to increase the number of drugs available on a given plan’s formulary.
Physician groups are expressing concerns regarding a new policy that will allow indication-based formulary design in the Medicare Part D prescription drug benefit.
The Centers for Medicare & Medicaid Services announced the new policy in an Aug. 29 memo to Part D plan sponsors.
According to a fact sheet issued by CMS on the same day, indication-based formulary design “is a formulary management tool that allows health plans to tailor on-formulary coverage of drugs predicated on specific indications.”
Current Part D policy requires plan sponsors to cover all Food and Drug Administration–approved indications for each drug that is on a plan formulary. Sponsors can begin to implement the new indication-based formulary design policy for plans issued in 2020.
The memo notes that if a Part D plan sponsor chooses to opt into this policy, “it must ensure that there is another therapeutically similar drug on formulary for the nonformulary indication. For example, if a tumor necrosis factor (TNF) blocker is FDA-approved for both Crohn’s disease and plaque psoriasis, but the Part D plan will include it on formulary for plaque psoriasis only, the plan must ensure that there is another TNF blocker on formulary that will be covered for Crohn’s disease.”
Beneficiaries can use the exceptions process to get coverage for a drug that has an indication not on the formulary.
“By allowing Medicare’s prescription drug plans to cover the best drug for each patient condition, plans will have more negotiating power with drug companies, which will result in lower prices for Medicare beneficiaries,” CMS Administrator Seema Verma said in a statement.
However, physician groups see this more as something that could create access issues for patients.
The “proposed changes will exacerbate many of the access issues patients currently face with plan usage of existing utilization management practices, such as step therapy,” the American College of Rheumatology said in a statement. “Unlike step therapy, which often delays effective treatments, this proposal would go even further and allow plans to remove therapies from the formulary altogether, leaving patients completely unable to access treatments that doctors and patients choose together. ... We also have concerns on what this would mean for work being done on compendia inclusion to secure off-label drug coverage if plans don’t have to cover all approved FDA-approved indications.”
The ACR called on CMS to clarify the exception process to make sure patients have access to their needed drugs.
The American Medical Association agreed.
“Under the plan, Medicare patients will face increased challenges as they navigate health plans to make sure that their needed drug is on their selected formulary, which can change based on what health conditions they have,” AMA President Barbara McAneny, MD, said in a statement. “While the CMS notice included a statement that plans had to include information addressing indication-based formularies in materials provided to prospective enrollees, that is not much help to patients who are not sophisticated in how formularies work.”
Dr. McAneny added that it will be even more difficult for physicians who are working with patients to get them on the best medicines covered by the patient’s formulary.
“Physicians already lack ready access to accurate formulary information – preferred/tier status, on/off formulary, PA [prior authorization] and step therapy requirements – at the point of care in their EHRs,” she said. “These transparency problems will expand by an order of magnitude by the complications this change introduces.”
She also noted that it could be difficult for patients who have multiple chronic conditions to find a drug plan that covers the range of their medications, although CMS said the move is expected to increase the number of drugs available on a given plan’s formulary.
Physician groups are expressing concerns regarding a new policy that will allow indication-based formulary design in the Medicare Part D prescription drug benefit.
The Centers for Medicare & Medicaid Services announced the new policy in an Aug. 29 memo to Part D plan sponsors.
According to a fact sheet issued by CMS on the same day, indication-based formulary design “is a formulary management tool that allows health plans to tailor on-formulary coverage of drugs predicated on specific indications.”
Current Part D policy requires plan sponsors to cover all Food and Drug Administration–approved indications for each drug that is on a plan formulary. Sponsors can begin to implement the new indication-based formulary design policy for plans issued in 2020.
The memo notes that if a Part D plan sponsor chooses to opt into this policy, “it must ensure that there is another therapeutically similar drug on formulary for the nonformulary indication. For example, if a tumor necrosis factor (TNF) blocker is FDA-approved for both Crohn’s disease and plaque psoriasis, but the Part D plan will include it on formulary for plaque psoriasis only, the plan must ensure that there is another TNF blocker on formulary that will be covered for Crohn’s disease.”
Beneficiaries can use the exceptions process to get coverage for a drug that has an indication not on the formulary.
“By allowing Medicare’s prescription drug plans to cover the best drug for each patient condition, plans will have more negotiating power with drug companies, which will result in lower prices for Medicare beneficiaries,” CMS Administrator Seema Verma said in a statement.
However, physician groups see this more as something that could create access issues for patients.
The “proposed changes will exacerbate many of the access issues patients currently face with plan usage of existing utilization management practices, such as step therapy,” the American College of Rheumatology said in a statement. “Unlike step therapy, which often delays effective treatments, this proposal would go even further and allow plans to remove therapies from the formulary altogether, leaving patients completely unable to access treatments that doctors and patients choose together. ... We also have concerns on what this would mean for work being done on compendia inclusion to secure off-label drug coverage if plans don’t have to cover all approved FDA-approved indications.”
The ACR called on CMS to clarify the exception process to make sure patients have access to their needed drugs.
The American Medical Association agreed.
“Under the plan, Medicare patients will face increased challenges as they navigate health plans to make sure that their needed drug is on their selected formulary, which can change based on what health conditions they have,” AMA President Barbara McAneny, MD, said in a statement. “While the CMS notice included a statement that plans had to include information addressing indication-based formularies in materials provided to prospective enrollees, that is not much help to patients who are not sophisticated in how formularies work.”
Dr. McAneny added that it will be even more difficult for physicians who are working with patients to get them on the best medicines covered by the patient’s formulary.
“Physicians already lack ready access to accurate formulary information – preferred/tier status, on/off formulary, PA [prior authorization] and step therapy requirements – at the point of care in their EHRs,” she said. “These transparency problems will expand by an order of magnitude by the complications this change introduces.”
She also noted that it could be difficult for patients who have multiple chronic conditions to find a drug plan that covers the range of their medications, although CMS said the move is expected to increase the number of drugs available on a given plan’s formulary.
Study examines POEM learning curve
Technical failures or adverse events complicated 4% of peroral endoscopic myotomies (POEMs) in a large single-center retrospective study.
Individual predictors of this composite negative outcome included case number, full-thickness myotomy, and procedure time, Zuqiang Liu, PhD, and his associates at Fudan University, Shanghai, China, wrote in the September issue of Clinical Gastroenterology and Hepatology.
After controlling for these risk factors, the composite rate of adverse events and technical failures dropped gradually after an endoscopist had performed his or her first 100 cases, according to the researchers. “Technical proficiency, demonstrated by plateauing of the procedure time, could be achieved after 70 cases,” they wrote. “The volume of cases required to manage challenging situations and prevent adverse events was thus higher than that needed for simple technical proficiency.” The experience of the training surgeon helped trainees gain technical proficiency faster, they added.
Peroral endoscopic myotomy (POEM) is minimally invasive and effectively treats spastic esophageal motility disorders. However, it is also a challenging procedure, and little is known about its learning curve. For the study, the researchers retrospectively reviewed technical failures and adverse events among 1,346 POEMs performed for achalasia at a single hospital in China between August 2010 and July 2015. They also assessed procedure time and a secondary composite outcome consisting of technical failure, adverse events, and clinical failure (further symptoms) for the first 192 cases performed by the original training surgeon.
There were 10 technical failures and 44 adverse events affecting a total of 54 patients (4%). Case number (P = .010), full-thickness myotomy (P = .002), and procedure time (P = .001) independently predicted this primary composite outcome. Adjusted cumulative sum analysis showed that the rate of this composite outcome decreased gradually after a surgeon had performed his or her first 100 cases. “The procedure time was high during the first few cases and decreased after endoscopists performed 70 cases,” indicating technical proficiency, the investigators wrote. The rate of the secondary composite outcome also fell gradually after the primary surgeon had performed between 90 and 100 cases.
For the first 192 cases performed by the lead surgeon, postprocedural follow-up time was typically 59 months, with a range of 3-71 months. Clinical failures occurred in 20 cases (10%). Rates of clinical failure were 6% at 1 year, 8% at 2 years, and 10% at 3 years.
This is the first study and the largest POEM database so far to assess the learning curve for this procedure by evaluating adverse events and clinical and technical failure, said the researchers. Previous studies consisted of small cases, usually of less than 100 patients each, they added. Such studies would inherently be biased because the smaller the caseload, the longer it might take for the learning curves of surgeons to plateau, they added.
Funders included the National Natural Science Foundation of China, the Major Project of Shanghai Municipal Science and Technology Committee, the Chen Guang Program of Shanghai Municipal Education Commission, and the Outstanding Young Doctor Training Project of Shanghai Municipal Commission of Health and Family Planning. The investigators reported having no relevant conflicts of interest.
SOURCE: Zuqiang L et al. Clin Gastroenterol Hepatol. 2017 Dec 5. doi: 10.1016/j.cgh.2017.11.048.
Determining competency in endoscopic procedures has been a vexing challenge since the introduction of flexible endoscopy. Traditionally, procedure volume has been used as a surrogate for technical competence. However, each endoscopist has their own learning curve. Furthermore, that curve is influenced by both the endoscopist and the characteristics of each patient. Thus, relying on procedure volume or length of time are likely inadequate markers of the true learning process. It has become more important to rely on more sophisticated measurements of competence, as illustrated in this study by Liu et al.
By using a large database of patients undergoing POEM, the authors applied risk-adjusted cumulative sum and moving averages (CUSUM) analysis to develop individual learning curves of six training endoscopists. The primary outcomes used to develop the curve were technical failure and adverse effects (likely the two outcomes patients are most concerned about). The analysis was adjusted for case complexity as well, reflecting that not all training episodes are the same. The results reveal that, although trainee endoscopists were able to perform POEM “quickly” by 70 cases, they did not achieve the more important primary outcomes of technical success and low adverse events until at least 100 procedures. This is akin to the difference between getting to the cecum quickly and having a high adenoma detection rate in colonoscopy.
Moving forward, using sophisticated measurement of individual endoscopists’ learning curves will allow maximal effectiveness of routine procedures such as colonoscopy.
Kal Patel, MD, is associate professor of medicine, Baylor College of Medicine, Houston. He has no conflicts of interest.
Determining competency in endoscopic procedures has been a vexing challenge since the introduction of flexible endoscopy. Traditionally, procedure volume has been used as a surrogate for technical competence. However, each endoscopist has their own learning curve. Furthermore, that curve is influenced by both the endoscopist and the characteristics of each patient. Thus, relying on procedure volume or length of time are likely inadequate markers of the true learning process. It has become more important to rely on more sophisticated measurements of competence, as illustrated in this study by Liu et al.
By using a large database of patients undergoing POEM, the authors applied risk-adjusted cumulative sum and moving averages (CUSUM) analysis to develop individual learning curves of six training endoscopists. The primary outcomes used to develop the curve were technical failure and adverse effects (likely the two outcomes patients are most concerned about). The analysis was adjusted for case complexity as well, reflecting that not all training episodes are the same. The results reveal that, although trainee endoscopists were able to perform POEM “quickly” by 70 cases, they did not achieve the more important primary outcomes of technical success and low adverse events until at least 100 procedures. This is akin to the difference between getting to the cecum quickly and having a high adenoma detection rate in colonoscopy.
Moving forward, using sophisticated measurement of individual endoscopists’ learning curves will allow maximal effectiveness of routine procedures such as colonoscopy.
Kal Patel, MD, is associate professor of medicine, Baylor College of Medicine, Houston. He has no conflicts of interest.
Determining competency in endoscopic procedures has been a vexing challenge since the introduction of flexible endoscopy. Traditionally, procedure volume has been used as a surrogate for technical competence. However, each endoscopist has their own learning curve. Furthermore, that curve is influenced by both the endoscopist and the characteristics of each patient. Thus, relying on procedure volume or length of time are likely inadequate markers of the true learning process. It has become more important to rely on more sophisticated measurements of competence, as illustrated in this study by Liu et al.
By using a large database of patients undergoing POEM, the authors applied risk-adjusted cumulative sum and moving averages (CUSUM) analysis to develop individual learning curves of six training endoscopists. The primary outcomes used to develop the curve were technical failure and adverse effects (likely the two outcomes patients are most concerned about). The analysis was adjusted for case complexity as well, reflecting that not all training episodes are the same. The results reveal that, although trainee endoscopists were able to perform POEM “quickly” by 70 cases, they did not achieve the more important primary outcomes of technical success and low adverse events until at least 100 procedures. This is akin to the difference between getting to the cecum quickly and having a high adenoma detection rate in colonoscopy.
Moving forward, using sophisticated measurement of individual endoscopists’ learning curves will allow maximal effectiveness of routine procedures such as colonoscopy.
Kal Patel, MD, is associate professor of medicine, Baylor College of Medicine, Houston. He has no conflicts of interest.
Technical failures or adverse events complicated 4% of peroral endoscopic myotomies (POEMs) in a large single-center retrospective study.
Individual predictors of this composite negative outcome included case number, full-thickness myotomy, and procedure time, Zuqiang Liu, PhD, and his associates at Fudan University, Shanghai, China, wrote in the September issue of Clinical Gastroenterology and Hepatology.
After controlling for these risk factors, the composite rate of adverse events and technical failures dropped gradually after an endoscopist had performed his or her first 100 cases, according to the researchers. “Technical proficiency, demonstrated by plateauing of the procedure time, could be achieved after 70 cases,” they wrote. “The volume of cases required to manage challenging situations and prevent adverse events was thus higher than that needed for simple technical proficiency.” The experience of the training surgeon helped trainees gain technical proficiency faster, they added.
Peroral endoscopic myotomy (POEM) is minimally invasive and effectively treats spastic esophageal motility disorders. However, it is also a challenging procedure, and little is known about its learning curve. For the study, the researchers retrospectively reviewed technical failures and adverse events among 1,346 POEMs performed for achalasia at a single hospital in China between August 2010 and July 2015. They also assessed procedure time and a secondary composite outcome consisting of technical failure, adverse events, and clinical failure (further symptoms) for the first 192 cases performed by the original training surgeon.
There were 10 technical failures and 44 adverse events affecting a total of 54 patients (4%). Case number (P = .010), full-thickness myotomy (P = .002), and procedure time (P = .001) independently predicted this primary composite outcome. Adjusted cumulative sum analysis showed that the rate of this composite outcome decreased gradually after a surgeon had performed his or her first 100 cases. “The procedure time was high during the first few cases and decreased after endoscopists performed 70 cases,” indicating technical proficiency, the investigators wrote. The rate of the secondary composite outcome also fell gradually after the primary surgeon had performed between 90 and 100 cases.
For the first 192 cases performed by the lead surgeon, postprocedural follow-up time was typically 59 months, with a range of 3-71 months. Clinical failures occurred in 20 cases (10%). Rates of clinical failure were 6% at 1 year, 8% at 2 years, and 10% at 3 years.
This is the first study and the largest POEM database so far to assess the learning curve for this procedure by evaluating adverse events and clinical and technical failure, said the researchers. Previous studies consisted of small cases, usually of less than 100 patients each, they added. Such studies would inherently be biased because the smaller the caseload, the longer it might take for the learning curves of surgeons to plateau, they added.
Funders included the National Natural Science Foundation of China, the Major Project of Shanghai Municipal Science and Technology Committee, the Chen Guang Program of Shanghai Municipal Education Commission, and the Outstanding Young Doctor Training Project of Shanghai Municipal Commission of Health and Family Planning. The investigators reported having no relevant conflicts of interest.
SOURCE: Zuqiang L et al. Clin Gastroenterol Hepatol. 2017 Dec 5. doi: 10.1016/j.cgh.2017.11.048.
Technical failures or adverse events complicated 4% of peroral endoscopic myotomies (POEMs) in a large single-center retrospective study.
Individual predictors of this composite negative outcome included case number, full-thickness myotomy, and procedure time, Zuqiang Liu, PhD, and his associates at Fudan University, Shanghai, China, wrote in the September issue of Clinical Gastroenterology and Hepatology.
After controlling for these risk factors, the composite rate of adverse events and technical failures dropped gradually after an endoscopist had performed his or her first 100 cases, according to the researchers. “Technical proficiency, demonstrated by plateauing of the procedure time, could be achieved after 70 cases,” they wrote. “The volume of cases required to manage challenging situations and prevent adverse events was thus higher than that needed for simple technical proficiency.” The experience of the training surgeon helped trainees gain technical proficiency faster, they added.
Peroral endoscopic myotomy (POEM) is minimally invasive and effectively treats spastic esophageal motility disorders. However, it is also a challenging procedure, and little is known about its learning curve. For the study, the researchers retrospectively reviewed technical failures and adverse events among 1,346 POEMs performed for achalasia at a single hospital in China between August 2010 and July 2015. They also assessed procedure time and a secondary composite outcome consisting of technical failure, adverse events, and clinical failure (further symptoms) for the first 192 cases performed by the original training surgeon.
There were 10 technical failures and 44 adverse events affecting a total of 54 patients (4%). Case number (P = .010), full-thickness myotomy (P = .002), and procedure time (P = .001) independently predicted this primary composite outcome. Adjusted cumulative sum analysis showed that the rate of this composite outcome decreased gradually after a surgeon had performed his or her first 100 cases. “The procedure time was high during the first few cases and decreased after endoscopists performed 70 cases,” indicating technical proficiency, the investigators wrote. The rate of the secondary composite outcome also fell gradually after the primary surgeon had performed between 90 and 100 cases.
For the first 192 cases performed by the lead surgeon, postprocedural follow-up time was typically 59 months, with a range of 3-71 months. Clinical failures occurred in 20 cases (10%). Rates of clinical failure were 6% at 1 year, 8% at 2 years, and 10% at 3 years.
This is the first study and the largest POEM database so far to assess the learning curve for this procedure by evaluating adverse events and clinical and technical failure, said the researchers. Previous studies consisted of small cases, usually of less than 100 patients each, they added. Such studies would inherently be biased because the smaller the caseload, the longer it might take for the learning curves of surgeons to plateau, they added.
Funders included the National Natural Science Foundation of China, the Major Project of Shanghai Municipal Science and Technology Committee, the Chen Guang Program of Shanghai Municipal Education Commission, and the Outstanding Young Doctor Training Project of Shanghai Municipal Commission of Health and Family Planning. The investigators reported having no relevant conflicts of interest.
SOURCE: Zuqiang L et al. Clin Gastroenterol Hepatol. 2017 Dec 5. doi: 10.1016/j.cgh.2017.11.048.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Key clinical point: One hundred cases was the typical learning curve for peroral endoscopic myotomy (POEM).
Major finding: The composite rate of technical failure or adverse events was 4%. An adjusted analysis showed that the rate of this negative composite outcome fell gradually after an endoscopist had performed his or her first 100 cases.
Study details: Single-center retrospective study of 1,346 patients undergoing POEM.
Disclosures: Funders included the National Natural Science Foundation of China, the Major Project of Shanghai Municipal Science and Technology Committee, the Chen Guang Program of Shanghai Municipal Education Commission, and the Outstanding Young Doctor Training Project of Shanghai Municipal Commission of Health and Family Planning. The investigators reported having no relevant conflicts of interest..
Source: Zuqiang L et al. Clin Gastroenterol Hepatol. 2017 Dec 5. doi: 10.1016/j.cgh.2017.11.048.
Patient transfers between hospitals contribute substantially to CDI burden
ATLANTA – Patient sharing among hospital facilities contributed substantially to the overall Clostridium difficile infection rate, an analysis of interhospital contamination effects showed.
In fact, 7.6% of all Clostridium difficile infection (CDI) cases at the nearly 400 California hospitals included in the study were directly attributable to the patient-sharing network, Daniel Sewell, PhD, reported at the International Conference on Emerging Infectious Diseases.
“The methods that we employed allowed us to estimate the expected increase in CDI cases due to transfers as a function of the CDI rate at the hospital from which those patients were brought. These transfer patients were responsible for about 3.06 times the number of CDI cases as a normal patient,” said Dr. Sewell, a biostatistician at the University of Iowa, Iowa City.
The findings, which underscored the importance of regional (rather than local) efforts to minimize the spread of health care–associated infections, are based on an analysis of 27,200,873 hospital admissions and 532,320 same-day patient transfers identified from the Healthcare Cost and Utilization Project California State Inpatient Database for 2005-2011.
Transfer networks based on the monthly average number of patients discharged from one hospital and admitted to another on the same day were constructed, and the monthly average number of CDI cases per hospital were considered, along with hospital-level characteristics such as patient length of stay, age, and number of diagnoses. Network autocorrelation models that help eliminate bias were then used to assess the contamination effects between hospitals, he explained.
This led to development of an equation that can be used to determine the expected number of CDI cases in a hospital as a function of the number of transfers coming in and the contamination level of the source hospitals. The ability to calculate the expected number of CDI cases in this fashion is an important factor for the success of regional versus local intervention efforts, which are increasingly thought to be important for reducing health care–associated infections.
“If we want to design a coordinated or regional approach, we’ve got to have a much better understanding of the role that patient transfers have in these diseases,” Dr. Sewell said.
As most hospitals included in the study had a low CDI rate and a low transfer rate, the CDIs attributable to transfers represent a minority of cases, but they are a substantial minority, he said, noting that the main concern is with the “perfect storm” of high CDI rate plus high transfer rate.
The methodological approach used in this study to estimate CDI rates can be used for any health care–associated infection of interest, he added.
Dr. Sewell reported that he had no disclosures.
ATLANTA – Patient sharing among hospital facilities contributed substantially to the overall Clostridium difficile infection rate, an analysis of interhospital contamination effects showed.
In fact, 7.6% of all Clostridium difficile infection (CDI) cases at the nearly 400 California hospitals included in the study were directly attributable to the patient-sharing network, Daniel Sewell, PhD, reported at the International Conference on Emerging Infectious Diseases.
“The methods that we employed allowed us to estimate the expected increase in CDI cases due to transfers as a function of the CDI rate at the hospital from which those patients were brought. These transfer patients were responsible for about 3.06 times the number of CDI cases as a normal patient,” said Dr. Sewell, a biostatistician at the University of Iowa, Iowa City.
The findings, which underscored the importance of regional (rather than local) efforts to minimize the spread of health care–associated infections, are based on an analysis of 27,200,873 hospital admissions and 532,320 same-day patient transfers identified from the Healthcare Cost and Utilization Project California State Inpatient Database for 2005-2011.
Transfer networks based on the monthly average number of patients discharged from one hospital and admitted to another on the same day were constructed, and the monthly average number of CDI cases per hospital were considered, along with hospital-level characteristics such as patient length of stay, age, and number of diagnoses. Network autocorrelation models that help eliminate bias were then used to assess the contamination effects between hospitals, he explained.
This led to development of an equation that can be used to determine the expected number of CDI cases in a hospital as a function of the number of transfers coming in and the contamination level of the source hospitals. The ability to calculate the expected number of CDI cases in this fashion is an important factor for the success of regional versus local intervention efforts, which are increasingly thought to be important for reducing health care–associated infections.
“If we want to design a coordinated or regional approach, we’ve got to have a much better understanding of the role that patient transfers have in these diseases,” Dr. Sewell said.
As most hospitals included in the study had a low CDI rate and a low transfer rate, the CDIs attributable to transfers represent a minority of cases, but they are a substantial minority, he said, noting that the main concern is with the “perfect storm” of high CDI rate plus high transfer rate.
The methodological approach used in this study to estimate CDI rates can be used for any health care–associated infection of interest, he added.
Dr. Sewell reported that he had no disclosures.
ATLANTA – Patient sharing among hospital facilities contributed substantially to the overall Clostridium difficile infection rate, an analysis of interhospital contamination effects showed.
In fact, 7.6% of all Clostridium difficile infection (CDI) cases at the nearly 400 California hospitals included in the study were directly attributable to the patient-sharing network, Daniel Sewell, PhD, reported at the International Conference on Emerging Infectious Diseases.
“The methods that we employed allowed us to estimate the expected increase in CDI cases due to transfers as a function of the CDI rate at the hospital from which those patients were brought. These transfer patients were responsible for about 3.06 times the number of CDI cases as a normal patient,” said Dr. Sewell, a biostatistician at the University of Iowa, Iowa City.
The findings, which underscored the importance of regional (rather than local) efforts to minimize the spread of health care–associated infections, are based on an analysis of 27,200,873 hospital admissions and 532,320 same-day patient transfers identified from the Healthcare Cost and Utilization Project California State Inpatient Database for 2005-2011.
Transfer networks based on the monthly average number of patients discharged from one hospital and admitted to another on the same day were constructed, and the monthly average number of CDI cases per hospital were considered, along with hospital-level characteristics such as patient length of stay, age, and number of diagnoses. Network autocorrelation models that help eliminate bias were then used to assess the contamination effects between hospitals, he explained.
This led to development of an equation that can be used to determine the expected number of CDI cases in a hospital as a function of the number of transfers coming in and the contamination level of the source hospitals. The ability to calculate the expected number of CDI cases in this fashion is an important factor for the success of regional versus local intervention efforts, which are increasingly thought to be important for reducing health care–associated infections.
“If we want to design a coordinated or regional approach, we’ve got to have a much better understanding of the role that patient transfers have in these diseases,” Dr. Sewell said.
As most hospitals included in the study had a low CDI rate and a low transfer rate, the CDIs attributable to transfers represent a minority of cases, but they are a substantial minority, he said, noting that the main concern is with the “perfect storm” of high CDI rate plus high transfer rate.
The methodological approach used in this study to estimate CDI rates can be used for any health care–associated infection of interest, he added.
Dr. Sewell reported that he had no disclosures.
REPORTING FROM ICEID 2018
Key clinical point: Patient sharing among hospitals contributes substantially to Clostridium difficile infection (CDI) rates.
Major finding: Patient transfers account for 7.6% of the overall CDI burden.
Study details: A statistical analysis to estimate interhospital CDI transmissions.
Disclosures: Dr. Sewell reported that he had no disclosures.
Hand hygiene linked to reduced ICU health care–associated infections
A hospital-wide infection control program (ICP) was found to be associated with reduced health care-associated severe sepsis/septic shock or death in the ICU, but it was not clear whether this decrease was a consequence of the ICP or because of a concomitant improvement in HAI case management, according to a the results of a prospective analysis.
In addition, there was no significant decrease in overall HAIs seen despite implementation of the program, according to the report published online in Clinical Microbiology and Infection (doi: 10.1016/j.cmi.2018.07.010), according to Stefan Hagel, MD, of the Institute for Infectious Diseases and Infection Control, Jena (Germany) University Hospital, and his colleagues.
They assessed two surveillance periods (September 2011 to August 2012 and May 2013 to August 2014). The ICP started in October 2012, and included hand-hygiene promotion and bundle implementation for common HAIs.
The data were analyzed by segmented mixed-effects Poisson regression and multi-state models and reported as adjusted incidence rate ratios (aIRR) and 50 adjusted hazard ratios (aHR) with 95% confidence intervals (CI).
In the first period, 62,154 patients were under surveillance, with 1,568 HAIs identified in 1,170 patients (4.3/100 admissions) and 2,336 HAIs identified in 1,711 patients (4.9/100 admissions) in the second surveillance period. No differences were found in the overall HAI incidence rates between the periods in the general wards and ICUs. There was only a slight decline in the incidence rate of HAIs in the ICUs (aIRR 0.98 [0.97, 1.00] per 1-week increment), compared with the general wards (aIRR 1.01 [1.00, 1.02]).
However, a reduction in severe HAIs (aIRR 0.13 [0.05, 0.32]) and a lower probability of HAI-associated in-hospital deaths (aHR 0.56 [0.31, 0.99]) were observed in the second period in the ICUs.
In attempting to explain the variance seen between the results for general wards and the ICU, an analysis of alcohol-based handrub solution consumption as a marker of hand-hygiene behavior indicated that a remarkable increase in consumption occurred in the ICUs while a less pronounced increase occurred in the general wards. “This finding might explain the observed decline in the HAI incidence after starting the campaign in the ICUs, which was not observed on the general wards.” Dr. Hagel and his colleagues suggested.
The authors discussed how several confounding factors that influenced the incidence of HAIs needed to be considered. As a consequence of the improvement in HAI management, the number of collected blood culture sets nearly doubled hospital-wide from 13,126 to 25,805 per year between 2011 and 2014, which likely undermined the study objective, they stated. The increase in cultures may have impacted the number of overall HAIs found.
“Although the primary aim of the study of reducing the overall incidence of HAIs was not achieved, the study demonstrated a decline of severe HAIs in patients in ICUs in the second surveillance period. Whether this result was a consequence of the ICP or a general improvement in HAI management remains unclear,” the researchers concluded.
The authors reported that they had no conflicts of interest.
SOURCE: Hagel S et al. Clin Microbiol Infect. doi: 10.1016/j.cmi.2018.07.010].
A hospital-wide infection control program (ICP) was found to be associated with reduced health care-associated severe sepsis/septic shock or death in the ICU, but it was not clear whether this decrease was a consequence of the ICP or because of a concomitant improvement in HAI case management, according to a the results of a prospective analysis.
In addition, there was no significant decrease in overall HAIs seen despite implementation of the program, according to the report published online in Clinical Microbiology and Infection (doi: 10.1016/j.cmi.2018.07.010), according to Stefan Hagel, MD, of the Institute for Infectious Diseases and Infection Control, Jena (Germany) University Hospital, and his colleagues.
They assessed two surveillance periods (September 2011 to August 2012 and May 2013 to August 2014). The ICP started in October 2012, and included hand-hygiene promotion and bundle implementation for common HAIs.
The data were analyzed by segmented mixed-effects Poisson regression and multi-state models and reported as adjusted incidence rate ratios (aIRR) and 50 adjusted hazard ratios (aHR) with 95% confidence intervals (CI).
In the first period, 62,154 patients were under surveillance, with 1,568 HAIs identified in 1,170 patients (4.3/100 admissions) and 2,336 HAIs identified in 1,711 patients (4.9/100 admissions) in the second surveillance period. No differences were found in the overall HAI incidence rates between the periods in the general wards and ICUs. There was only a slight decline in the incidence rate of HAIs in the ICUs (aIRR 0.98 [0.97, 1.00] per 1-week increment), compared with the general wards (aIRR 1.01 [1.00, 1.02]).
However, a reduction in severe HAIs (aIRR 0.13 [0.05, 0.32]) and a lower probability of HAI-associated in-hospital deaths (aHR 0.56 [0.31, 0.99]) were observed in the second period in the ICUs.
In attempting to explain the variance seen between the results for general wards and the ICU, an analysis of alcohol-based handrub solution consumption as a marker of hand-hygiene behavior indicated that a remarkable increase in consumption occurred in the ICUs while a less pronounced increase occurred in the general wards. “This finding might explain the observed decline in the HAI incidence after starting the campaign in the ICUs, which was not observed on the general wards.” Dr. Hagel and his colleagues suggested.
The authors discussed how several confounding factors that influenced the incidence of HAIs needed to be considered. As a consequence of the improvement in HAI management, the number of collected blood culture sets nearly doubled hospital-wide from 13,126 to 25,805 per year between 2011 and 2014, which likely undermined the study objective, they stated. The increase in cultures may have impacted the number of overall HAIs found.
“Although the primary aim of the study of reducing the overall incidence of HAIs was not achieved, the study demonstrated a decline of severe HAIs in patients in ICUs in the second surveillance period. Whether this result was a consequence of the ICP or a general improvement in HAI management remains unclear,” the researchers concluded.
The authors reported that they had no conflicts of interest.
SOURCE: Hagel S et al. Clin Microbiol Infect. doi: 10.1016/j.cmi.2018.07.010].
A hospital-wide infection control program (ICP) was found to be associated with reduced health care-associated severe sepsis/septic shock or death in the ICU, but it was not clear whether this decrease was a consequence of the ICP or because of a concomitant improvement in HAI case management, according to a the results of a prospective analysis.
In addition, there was no significant decrease in overall HAIs seen despite implementation of the program, according to the report published online in Clinical Microbiology and Infection (doi: 10.1016/j.cmi.2018.07.010), according to Stefan Hagel, MD, of the Institute for Infectious Diseases and Infection Control, Jena (Germany) University Hospital, and his colleagues.
They assessed two surveillance periods (September 2011 to August 2012 and May 2013 to August 2014). The ICP started in October 2012, and included hand-hygiene promotion and bundle implementation for common HAIs.
The data were analyzed by segmented mixed-effects Poisson regression and multi-state models and reported as adjusted incidence rate ratios (aIRR) and 50 adjusted hazard ratios (aHR) with 95% confidence intervals (CI).
In the first period, 62,154 patients were under surveillance, with 1,568 HAIs identified in 1,170 patients (4.3/100 admissions) and 2,336 HAIs identified in 1,711 patients (4.9/100 admissions) in the second surveillance period. No differences were found in the overall HAI incidence rates between the periods in the general wards and ICUs. There was only a slight decline in the incidence rate of HAIs in the ICUs (aIRR 0.98 [0.97, 1.00] per 1-week increment), compared with the general wards (aIRR 1.01 [1.00, 1.02]).
However, a reduction in severe HAIs (aIRR 0.13 [0.05, 0.32]) and a lower probability of HAI-associated in-hospital deaths (aHR 0.56 [0.31, 0.99]) were observed in the second period in the ICUs.
In attempting to explain the variance seen between the results for general wards and the ICU, an analysis of alcohol-based handrub solution consumption as a marker of hand-hygiene behavior indicated that a remarkable increase in consumption occurred in the ICUs while a less pronounced increase occurred in the general wards. “This finding might explain the observed decline in the HAI incidence after starting the campaign in the ICUs, which was not observed on the general wards.” Dr. Hagel and his colleagues suggested.
The authors discussed how several confounding factors that influenced the incidence of HAIs needed to be considered. As a consequence of the improvement in HAI management, the number of collected blood culture sets nearly doubled hospital-wide from 13,126 to 25,805 per year between 2011 and 2014, which likely undermined the study objective, they stated. The increase in cultures may have impacted the number of overall HAIs found.
“Although the primary aim of the study of reducing the overall incidence of HAIs was not achieved, the study demonstrated a decline of severe HAIs in patients in ICUs in the second surveillance period. Whether this result was a consequence of the ICP or a general improvement in HAI management remains unclear,” the researchers concluded.
The authors reported that they had no conflicts of interest.
SOURCE: Hagel S et al. Clin Microbiol Infect. doi: 10.1016/j.cmi.2018.07.010].
FROM CLINICAL MICROBIOLOGY AND INFECTION
Key clinical point: Hand hygiene was the key factor associated with a decrease in severe HAIs.
Major finding: A reduction in severe HAIs (aIRR 0.13) and a lower probability of HAI-associated in-hospital deaths (aHR 0.56]) were observed.
Study details: A prospective database analysis of more nearly 65,000 hospitalized patients.
Disclosures: The authors reported that they had no conflicts of interest.
Source: Hagel S et al. Clin Microbiol Infect. doi: 10.1016/j.cmi.2018.07.010.
McCain’s complicated health care legacy: He hated the ACA. He also saved it
There are many lawmakers who made their names in health care, seeking to usher through historic changes to a broken system.
Sen. John McCain was not one of them.
And yet, the six-term senator from Arizona and decorated military veteran leaves behind his own health care legacy, seemingly driven less by his interest in health care policy than his disdain for bullies trampling the “little guy.”
He was not always successful. While Sen. McCain was instrumental in the passage of the Americans with Disabilities Act in 1990, most of the health initiatives he undertook failed after running afoul of traditional Republican priorities. His prescriptions often involved more government regulation and increased taxes.
In 2008, as the Republican nominee for president, he ran on a health care platform that dumbfounded many in his party who worried it would raise taxes on top of overhauling the U.S. tradition of workplace insurance.
Many will remember Sen. McCain as the incidental savior of the Affordable Care Act, whose late-night thumbs-down vote halted his party’s most promising effort to overturn a major Democratic achievement – the signature achievement, in fact, of the Democrat who beat him to become president. It was a vote that earned him regular – and biting – admonishments from President Donald Trump.
Sen. McCain died Aug. 25, following a battle with brain cancer. He was 81. Coincidentally, his Senate colleague and good friend Ted Kennedy died on the same date, Aug. 25, 9 years ago, succumbing to the same type of rare brain tumor.
Whether indulging in conspiracy theories or wishful thinking, some have attributed Sen. McCain’s vote on the ACA in July 2017 to a change of heart shortly after his terminal cancer diagnosis.
But Sen. McCain spent much of his 35 years in Congress fighting a never-ending supply of goliaths, among them health insurance companies, the tobacco industry and, in his estimation, the Affordable Care Act, a law that extended insurance coverage to millions of Americans but did not solve the system’s ballooning costs.
His prey were the sort of boogeymen that made for compelling campaign ads in a career stacked with campaigns. But Sen. McCain was “always for the little guy,” said Douglas Holtz-Eakin, the chief domestic policy adviser on Sen. McCain’s 2008 presidential campaign.
“John’s idea of empathy is saying to you, ‘I’ll punch the bully for you,’ ” he said in an interview before Sen. McCain’s death.
Sen. McCain’s distaste for President Barack Obama’s health care law was no secret. While he agreed that the health care system was broken, he did not think more government involvement would fix it. Like most Republicans, he campaigned in his last Senate race on a promise to repeal and replace the law with something better.
After Republicans spent months bickering amongst themselves about what was better, Sen. McCain was disappointed in the option presented to senators hours before their vote: Hobble the ACA, and trust that a handful of lawmakers would be able to craft an alternative behind closed doors, despite failing to accomplish that very thing after years of trying.
What bothered Sen. McCain more, though, was his party’s strategy to pass their so-called skinny repeal measure, skipping committee consideration and delivering it straight to the floor. They also rejected any input from the opposing party, a tactic for which he had slammed Democrats when the ACA passed in 2010 without a single GOP vote. He lamented that Republican leaders had cast aside compromise-nurturing Senate procedures in pursuit of political victory.
In his 2018 memoirs, “The Restless Wave,” Sen. McCain said even President Obama called to express gratitude for Sen. McCain’s vote against the Republican repeal bill.
“I was thanked for my vote by Democratic friends more profusely than I should have been for helping save Obamacare,” Sen. McCain wrote. “That had not been my goal.”
Better known for his work on campaign finance reform and the military, Sen. McCain did have a hand in one landmark health bill – the Americans with Disabilities Act of 1990, the country’s first comprehensive civil rights law that addressed the needs of those with disabilities. An early cosponsor of the legislation, he championed the rights of the disabled, speaking of the service members and civilians he met in his travels who had become disabled during military conflict.
Sen. McCain himself had limited use of his arms due to injuries inflicted while he was a prisoner of war in Vietnam, though he was quicker to talk about the troubles of others than his own when advocating policy.
Yet two of his biggest bills on health care ended in defeat.
In 1998, Sen. McCain introduced a sweeping bill that would regulate the tobacco industry and increase taxes on cigarettes, hoping to discourage teenagers from smoking and raise money for research and related health care costs. It faltered under opposition from his fellow Republicans.
Sen. McCain also joined an effort with two Democratic senators, Sen. Kennedy of Massachusetts and Sen. John Edwards of North Carolina, to pass a patients’ bill of rights in 2001. He resisted at first, concerned in particular about the right it gave patients to sue health care companies, said Sonya Elling, who served as a health care aide in Sen. McCain’s office for about a decade. But he came around.
“It was the human, the personal aspect of it, basically,” said Ms. Elling, now senior director of federal affairs at Eli Lilly. “It was providing him some of the real stories about how people were being hurt and some of the barriers that existed for people in the current system.”
The legislation would have granted patients with private insurance the right to emergency and specialist care in addition to the right to seek redress for being wrongly denied care. But President George W. Bush threatened to veto the measure, claiming it would fuel frivolous lawsuits. The bill failed.
Sen. McCain’s health care efforts bolstered his reputation as a lawmaker willing to work across the aisle. Sen. Chuck Schumer of New York, now the Senate’s Democratic leader, sought his help on legislation in 2001 to expand access to generic drugs. In 2015, Sen. McCain led a bipartisan coalition to pass a law that would strengthen mental health and suicide prevention programs for veterans, among other veterans’ care measures he undertook.
It was Sen. McCain’s relationship with Sen. Kennedy that stood out, inspiring eerie comparisons when Sen. McCain was diagnosed last year with glioblastoma – a form of brain cancer – shortly before his vote saved the Affordable Care Act.
That same aggressive brain cancer killed Sen. Kennedy in 2009, months before the passage of the law that helped realize his work to secure better access for Americans to health care.
“I had strenuously opposed it, but I was very sorry that Ted had not lived to see his long crusade come to a successful end,” Sen. McCain wrote in his 2018 book.
While some of his biggest health care measures failed, the experiences helped burnish Sen. McCain’s résumé for his 2000 and 2008 presidential campaigns.
In 2007, trailing other favored Republicans, such as former New York City mayor Rudy Giuliani in early polling and fundraising, Sen. McCain asked his advisers to craft a health care proposal, said Mr. Holtz-Eakin. It was an unusual move for a Republican presidential primary.
The result was a remarkable plan that would eliminate the tax break employers get for providing health benefits to workers, known as the employer exclusion, and replace it with refundable tax credits to help people – not just those working in firms that supplied coverage – buy insurance individually. He argued employer-provided plans were driving up costs, as well as keeping salaries lower.
The plan was controversial, triggering “a total freak-out” when Sen. McCain gained more prominence and scrutiny, Mr. Holtz-Eakin said. But Sen. McCain stood by it.
“He might not have been a health guy, but he knew how important that was,” he said. “And he was relentless about getting it done.”
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
There are many lawmakers who made their names in health care, seeking to usher through historic changes to a broken system.
Sen. John McCain was not one of them.
And yet, the six-term senator from Arizona and decorated military veteran leaves behind his own health care legacy, seemingly driven less by his interest in health care policy than his disdain for bullies trampling the “little guy.”
He was not always successful. While Sen. McCain was instrumental in the passage of the Americans with Disabilities Act in 1990, most of the health initiatives he undertook failed after running afoul of traditional Republican priorities. His prescriptions often involved more government regulation and increased taxes.
In 2008, as the Republican nominee for president, he ran on a health care platform that dumbfounded many in his party who worried it would raise taxes on top of overhauling the U.S. tradition of workplace insurance.
Many will remember Sen. McCain as the incidental savior of the Affordable Care Act, whose late-night thumbs-down vote halted his party’s most promising effort to overturn a major Democratic achievement – the signature achievement, in fact, of the Democrat who beat him to become president. It was a vote that earned him regular – and biting – admonishments from President Donald Trump.
Sen. McCain died Aug. 25, following a battle with brain cancer. He was 81. Coincidentally, his Senate colleague and good friend Ted Kennedy died on the same date, Aug. 25, 9 years ago, succumbing to the same type of rare brain tumor.
Whether indulging in conspiracy theories or wishful thinking, some have attributed Sen. McCain’s vote on the ACA in July 2017 to a change of heart shortly after his terminal cancer diagnosis.
But Sen. McCain spent much of his 35 years in Congress fighting a never-ending supply of goliaths, among them health insurance companies, the tobacco industry and, in his estimation, the Affordable Care Act, a law that extended insurance coverage to millions of Americans but did not solve the system’s ballooning costs.
His prey were the sort of boogeymen that made for compelling campaign ads in a career stacked with campaigns. But Sen. McCain was “always for the little guy,” said Douglas Holtz-Eakin, the chief domestic policy adviser on Sen. McCain’s 2008 presidential campaign.
“John’s idea of empathy is saying to you, ‘I’ll punch the bully for you,’ ” he said in an interview before Sen. McCain’s death.
Sen. McCain’s distaste for President Barack Obama’s health care law was no secret. While he agreed that the health care system was broken, he did not think more government involvement would fix it. Like most Republicans, he campaigned in his last Senate race on a promise to repeal and replace the law with something better.
After Republicans spent months bickering amongst themselves about what was better, Sen. McCain was disappointed in the option presented to senators hours before their vote: Hobble the ACA, and trust that a handful of lawmakers would be able to craft an alternative behind closed doors, despite failing to accomplish that very thing after years of trying.
What bothered Sen. McCain more, though, was his party’s strategy to pass their so-called skinny repeal measure, skipping committee consideration and delivering it straight to the floor. They also rejected any input from the opposing party, a tactic for which he had slammed Democrats when the ACA passed in 2010 without a single GOP vote. He lamented that Republican leaders had cast aside compromise-nurturing Senate procedures in pursuit of political victory.
In his 2018 memoirs, “The Restless Wave,” Sen. McCain said even President Obama called to express gratitude for Sen. McCain’s vote against the Republican repeal bill.
“I was thanked for my vote by Democratic friends more profusely than I should have been for helping save Obamacare,” Sen. McCain wrote. “That had not been my goal.”
Better known for his work on campaign finance reform and the military, Sen. McCain did have a hand in one landmark health bill – the Americans with Disabilities Act of 1990, the country’s first comprehensive civil rights law that addressed the needs of those with disabilities. An early cosponsor of the legislation, he championed the rights of the disabled, speaking of the service members and civilians he met in his travels who had become disabled during military conflict.
Sen. McCain himself had limited use of his arms due to injuries inflicted while he was a prisoner of war in Vietnam, though he was quicker to talk about the troubles of others than his own when advocating policy.
Yet two of his biggest bills on health care ended in defeat.
In 1998, Sen. McCain introduced a sweeping bill that would regulate the tobacco industry and increase taxes on cigarettes, hoping to discourage teenagers from smoking and raise money for research and related health care costs. It faltered under opposition from his fellow Republicans.
Sen. McCain also joined an effort with two Democratic senators, Sen. Kennedy of Massachusetts and Sen. John Edwards of North Carolina, to pass a patients’ bill of rights in 2001. He resisted at first, concerned in particular about the right it gave patients to sue health care companies, said Sonya Elling, who served as a health care aide in Sen. McCain’s office for about a decade. But he came around.
“It was the human, the personal aspect of it, basically,” said Ms. Elling, now senior director of federal affairs at Eli Lilly. “It was providing him some of the real stories about how people were being hurt and some of the barriers that existed for people in the current system.”
The legislation would have granted patients with private insurance the right to emergency and specialist care in addition to the right to seek redress for being wrongly denied care. But President George W. Bush threatened to veto the measure, claiming it would fuel frivolous lawsuits. The bill failed.
Sen. McCain’s health care efforts bolstered his reputation as a lawmaker willing to work across the aisle. Sen. Chuck Schumer of New York, now the Senate’s Democratic leader, sought his help on legislation in 2001 to expand access to generic drugs. In 2015, Sen. McCain led a bipartisan coalition to pass a law that would strengthen mental health and suicide prevention programs for veterans, among other veterans’ care measures he undertook.
It was Sen. McCain’s relationship with Sen. Kennedy that stood out, inspiring eerie comparisons when Sen. McCain was diagnosed last year with glioblastoma – a form of brain cancer – shortly before his vote saved the Affordable Care Act.
That same aggressive brain cancer killed Sen. Kennedy in 2009, months before the passage of the law that helped realize his work to secure better access for Americans to health care.
“I had strenuously opposed it, but I was very sorry that Ted had not lived to see his long crusade come to a successful end,” Sen. McCain wrote in his 2018 book.
While some of his biggest health care measures failed, the experiences helped burnish Sen. McCain’s résumé for his 2000 and 2008 presidential campaigns.
In 2007, trailing other favored Republicans, such as former New York City mayor Rudy Giuliani in early polling and fundraising, Sen. McCain asked his advisers to craft a health care proposal, said Mr. Holtz-Eakin. It was an unusual move for a Republican presidential primary.
The result was a remarkable plan that would eliminate the tax break employers get for providing health benefits to workers, known as the employer exclusion, and replace it with refundable tax credits to help people – not just those working in firms that supplied coverage – buy insurance individually. He argued employer-provided plans were driving up costs, as well as keeping salaries lower.
The plan was controversial, triggering “a total freak-out” when Sen. McCain gained more prominence and scrutiny, Mr. Holtz-Eakin said. But Sen. McCain stood by it.
“He might not have been a health guy, but he knew how important that was,” he said. “And he was relentless about getting it done.”
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
There are many lawmakers who made their names in health care, seeking to usher through historic changes to a broken system.
Sen. John McCain was not one of them.
And yet, the six-term senator from Arizona and decorated military veteran leaves behind his own health care legacy, seemingly driven less by his interest in health care policy than his disdain for bullies trampling the “little guy.”
He was not always successful. While Sen. McCain was instrumental in the passage of the Americans with Disabilities Act in 1990, most of the health initiatives he undertook failed after running afoul of traditional Republican priorities. His prescriptions often involved more government regulation and increased taxes.
In 2008, as the Republican nominee for president, he ran on a health care platform that dumbfounded many in his party who worried it would raise taxes on top of overhauling the U.S. tradition of workplace insurance.
Many will remember Sen. McCain as the incidental savior of the Affordable Care Act, whose late-night thumbs-down vote halted his party’s most promising effort to overturn a major Democratic achievement – the signature achievement, in fact, of the Democrat who beat him to become president. It was a vote that earned him regular – and biting – admonishments from President Donald Trump.
Sen. McCain died Aug. 25, following a battle with brain cancer. He was 81. Coincidentally, his Senate colleague and good friend Ted Kennedy died on the same date, Aug. 25, 9 years ago, succumbing to the same type of rare brain tumor.
Whether indulging in conspiracy theories or wishful thinking, some have attributed Sen. McCain’s vote on the ACA in July 2017 to a change of heart shortly after his terminal cancer diagnosis.
But Sen. McCain spent much of his 35 years in Congress fighting a never-ending supply of goliaths, among them health insurance companies, the tobacco industry and, in his estimation, the Affordable Care Act, a law that extended insurance coverage to millions of Americans but did not solve the system’s ballooning costs.
His prey were the sort of boogeymen that made for compelling campaign ads in a career stacked with campaigns. But Sen. McCain was “always for the little guy,” said Douglas Holtz-Eakin, the chief domestic policy adviser on Sen. McCain’s 2008 presidential campaign.
“John’s idea of empathy is saying to you, ‘I’ll punch the bully for you,’ ” he said in an interview before Sen. McCain’s death.
Sen. McCain’s distaste for President Barack Obama’s health care law was no secret. While he agreed that the health care system was broken, he did not think more government involvement would fix it. Like most Republicans, he campaigned in his last Senate race on a promise to repeal and replace the law with something better.
After Republicans spent months bickering amongst themselves about what was better, Sen. McCain was disappointed in the option presented to senators hours before their vote: Hobble the ACA, and trust that a handful of lawmakers would be able to craft an alternative behind closed doors, despite failing to accomplish that very thing after years of trying.
What bothered Sen. McCain more, though, was his party’s strategy to pass their so-called skinny repeal measure, skipping committee consideration and delivering it straight to the floor. They also rejected any input from the opposing party, a tactic for which he had slammed Democrats when the ACA passed in 2010 without a single GOP vote. He lamented that Republican leaders had cast aside compromise-nurturing Senate procedures in pursuit of political victory.
In his 2018 memoirs, “The Restless Wave,” Sen. McCain said even President Obama called to express gratitude for Sen. McCain’s vote against the Republican repeal bill.
“I was thanked for my vote by Democratic friends more profusely than I should have been for helping save Obamacare,” Sen. McCain wrote. “That had not been my goal.”
Better known for his work on campaign finance reform and the military, Sen. McCain did have a hand in one landmark health bill – the Americans with Disabilities Act of 1990, the country’s first comprehensive civil rights law that addressed the needs of those with disabilities. An early cosponsor of the legislation, he championed the rights of the disabled, speaking of the service members and civilians he met in his travels who had become disabled during military conflict.
Sen. McCain himself had limited use of his arms due to injuries inflicted while he was a prisoner of war in Vietnam, though he was quicker to talk about the troubles of others than his own when advocating policy.
Yet two of his biggest bills on health care ended in defeat.
In 1998, Sen. McCain introduced a sweeping bill that would regulate the tobacco industry and increase taxes on cigarettes, hoping to discourage teenagers from smoking and raise money for research and related health care costs. It faltered under opposition from his fellow Republicans.
Sen. McCain also joined an effort with two Democratic senators, Sen. Kennedy of Massachusetts and Sen. John Edwards of North Carolina, to pass a patients’ bill of rights in 2001. He resisted at first, concerned in particular about the right it gave patients to sue health care companies, said Sonya Elling, who served as a health care aide in Sen. McCain’s office for about a decade. But he came around.
“It was the human, the personal aspect of it, basically,” said Ms. Elling, now senior director of federal affairs at Eli Lilly. “It was providing him some of the real stories about how people were being hurt and some of the barriers that existed for people in the current system.”
The legislation would have granted patients with private insurance the right to emergency and specialist care in addition to the right to seek redress for being wrongly denied care. But President George W. Bush threatened to veto the measure, claiming it would fuel frivolous lawsuits. The bill failed.
Sen. McCain’s health care efforts bolstered his reputation as a lawmaker willing to work across the aisle. Sen. Chuck Schumer of New York, now the Senate’s Democratic leader, sought his help on legislation in 2001 to expand access to generic drugs. In 2015, Sen. McCain led a bipartisan coalition to pass a law that would strengthen mental health and suicide prevention programs for veterans, among other veterans’ care measures he undertook.
It was Sen. McCain’s relationship with Sen. Kennedy that stood out, inspiring eerie comparisons when Sen. McCain was diagnosed last year with glioblastoma – a form of brain cancer – shortly before his vote saved the Affordable Care Act.
That same aggressive brain cancer killed Sen. Kennedy in 2009, months before the passage of the law that helped realize his work to secure better access for Americans to health care.
“I had strenuously opposed it, but I was very sorry that Ted had not lived to see his long crusade come to a successful end,” Sen. McCain wrote in his 2018 book.
While some of his biggest health care measures failed, the experiences helped burnish Sen. McCain’s résumé for his 2000 and 2008 presidential campaigns.
In 2007, trailing other favored Republicans, such as former New York City mayor Rudy Giuliani in early polling and fundraising, Sen. McCain asked his advisers to craft a health care proposal, said Mr. Holtz-Eakin. It was an unusual move for a Republican presidential primary.
The result was a remarkable plan that would eliminate the tax break employers get for providing health benefits to workers, known as the employer exclusion, and replace it with refundable tax credits to help people – not just those working in firms that supplied coverage – buy insurance individually. He argued employer-provided plans were driving up costs, as well as keeping salaries lower.
The plan was controversial, triggering “a total freak-out” when Sen. McCain gained more prominence and scrutiny, Mr. Holtz-Eakin said. But Sen. McCain stood by it.
“He might not have been a health guy, but he knew how important that was,” he said. “And he was relentless about getting it done.”
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Medicare donut hole: Fewer enrollees, more spending in 2016
Those 5.2 million enrollees in 2016 represented a reversal from the rising number of those reaching the coverage-gap over the last 3 years and the potential start of a trend toward increasing out-of-pocket costs. The number of part D enrollees without low-income subsidies (the coverage gap does not apply to those who receive the subsidies) had risen from 2013 to 2015 after being fairly stable from 2007 to 2012. The average out-of-pocket cost for enrollees with low-income subsidies, on the other hand, dropped by 20% in 2011 – from $1,858 to $1,485 – with a smaller drop in 2013 before two consecutive years of increases in 2015 and 2016, Kaiser reported.
“As of 2019, there will no longer be a coverage gap for brand-name drugs, as a result of changes in the” Bipartisan Budget Act of 2018, which reduced enrollees’ share of costs and increased the manufacturer discount, Kaiser explained, but a proposal from the Trump administration “to exclude the manufacturer discount from the calculation of out-of-pocket spending would substantially increase part D enrollees’ out-of-pocket costs and would lead to fewer enrollees qualifying for catastrophic coverage.”
Those 5.2 million enrollees in 2016 represented a reversal from the rising number of those reaching the coverage-gap over the last 3 years and the potential start of a trend toward increasing out-of-pocket costs. The number of part D enrollees without low-income subsidies (the coverage gap does not apply to those who receive the subsidies) had risen from 2013 to 2015 after being fairly stable from 2007 to 2012. The average out-of-pocket cost for enrollees with low-income subsidies, on the other hand, dropped by 20% in 2011 – from $1,858 to $1,485 – with a smaller drop in 2013 before two consecutive years of increases in 2015 and 2016, Kaiser reported.
“As of 2019, there will no longer be a coverage gap for brand-name drugs, as a result of changes in the” Bipartisan Budget Act of 2018, which reduced enrollees’ share of costs and increased the manufacturer discount, Kaiser explained, but a proposal from the Trump administration “to exclude the manufacturer discount from the calculation of out-of-pocket spending would substantially increase part D enrollees’ out-of-pocket costs and would lead to fewer enrollees qualifying for catastrophic coverage.”
Those 5.2 million enrollees in 2016 represented a reversal from the rising number of those reaching the coverage-gap over the last 3 years and the potential start of a trend toward increasing out-of-pocket costs. The number of part D enrollees without low-income subsidies (the coverage gap does not apply to those who receive the subsidies) had risen from 2013 to 2015 after being fairly stable from 2007 to 2012. The average out-of-pocket cost for enrollees with low-income subsidies, on the other hand, dropped by 20% in 2011 – from $1,858 to $1,485 – with a smaller drop in 2013 before two consecutive years of increases in 2015 and 2016, Kaiser reported.
“As of 2019, there will no longer be a coverage gap for brand-name drugs, as a result of changes in the” Bipartisan Budget Act of 2018, which reduced enrollees’ share of costs and increased the manufacturer discount, Kaiser explained, but a proposal from the Trump administration “to exclude the manufacturer discount from the calculation of out-of-pocket spending would substantially increase part D enrollees’ out-of-pocket costs and would lead to fewer enrollees qualifying for catastrophic coverage.”
Restrictive transfusions do not increase long-term CV surgery risk
MUNICH – in a large, randomized trial presented at the annual congress of the European Society of Cardiology, and published simultaneously in the New England Journal of Medicine.
The investigators previously reported that 28 day outcomes were non-inferior with the restrictive approach, but they wanted to look into 6 month results to rule out latent problems, such as sequelae from perioperative organ hypoxia.
The new outcomes from the study, dubbed the Transfusion Requirements in Cardiac Surgery (TRICS) III trial, offer some reassurance at a time when cardiac surgeons are shifting towards more restrictive transfusion policies (N Engl J Med. 2018 Aug 26.doi: 10.1056/NEJMoa1808561).
The trial randomized 2,317 patients to red cell transfusions if their hemoglobin concentrations fell below 7.5 g/dL intraoperatively or postoperatively. Another 2,347 were randomized to the liberal approach, with transfusions below 9.5 g/dL in the operating room and ICU, and below 8.5 g/dL outside of the ICU. The arms were well matched, with a mean score of 8 in both groups on the 47-point European System for Cardiac Operative Risk Evaluation I score.
At 6 months, 17.4% of patients in the restrictive arm, versus 17.1% in the liberal-threshold group, met the primary composite outcome of death from any cause, myocardial infarction, stroke, or new onset renal failure with dialysis (P = .006 for noninferiority with the restrictive threshold); 6.2% of patients in the restrictive-threshold group, versus 6.4% in the liberal-arm, had died at that point, a statistically insignificant difference.
Also at 6 months, 43.8% of patients in the restrictive-threshold group, versus 42.8% in the liberal arm, met the study’s secondary composite outcome, which included the components of the primary outcome plus hospital readmissions, ED visits, and coronary revascularization. The difference was again statistically insignificant.
The restrictive strategy saved a lot of blood. Just over half of the patients, versus almost three-quarters in the liberal arm, were transfused during their index admissions. When transfused, patients in the restrictive arm received a median of 2 units of red cells; liberal-arm patients received a median of 3 units.
Unexpectedly, patients 75 years and older had a lower risk of poor outcomes with the restrictive strategy, while the liberal strategy was associated with lower risk in younger subjects. The findings “appear to contradict” current practice, “in which a liberal transfusion strategy is used in older patients undergoing cardiac or noncardiac surgery,” said investigators led by C. David Mazer, MD, a professor in the department of anesthesia at the University of Toronto.
“One could hypothesize that older patients may have unacceptable adverse effects related to transfusion (e.g., volume overload and inflammatory and infectious complications) or that there may be age-related differences in the adverse-effect profile of transfusion or anemia. ... Whether transfusion thresholds should differ according to age” needs to be determined, they said.
The participants were a mean of 72 years old, and 35% were women. The majority in both arms underwent coronary artery bypass surgery, valve surgery, or both. Heart transplants were excluded. The trial was conducted in 19 countries, including China and India; results were consistent across study sites.
The work was funded by the Canadian Institutes of Health Research, among others. Dr. Mazer had no relevant disclosures.
SOURCE: Mazer CD et al. N Engl J Med. 2018 Aug 26. doi:10.1056/NEJMoa1808561
MUNICH – in a large, randomized trial presented at the annual congress of the European Society of Cardiology, and published simultaneously in the New England Journal of Medicine.
The investigators previously reported that 28 day outcomes were non-inferior with the restrictive approach, but they wanted to look into 6 month results to rule out latent problems, such as sequelae from perioperative organ hypoxia.
The new outcomes from the study, dubbed the Transfusion Requirements in Cardiac Surgery (TRICS) III trial, offer some reassurance at a time when cardiac surgeons are shifting towards more restrictive transfusion policies (N Engl J Med. 2018 Aug 26.doi: 10.1056/NEJMoa1808561).
The trial randomized 2,317 patients to red cell transfusions if their hemoglobin concentrations fell below 7.5 g/dL intraoperatively or postoperatively. Another 2,347 were randomized to the liberal approach, with transfusions below 9.5 g/dL in the operating room and ICU, and below 8.5 g/dL outside of the ICU. The arms were well matched, with a mean score of 8 in both groups on the 47-point European System for Cardiac Operative Risk Evaluation I score.
At 6 months, 17.4% of patients in the restrictive arm, versus 17.1% in the liberal-threshold group, met the primary composite outcome of death from any cause, myocardial infarction, stroke, or new onset renal failure with dialysis (P = .006 for noninferiority with the restrictive threshold); 6.2% of patients in the restrictive-threshold group, versus 6.4% in the liberal-arm, had died at that point, a statistically insignificant difference.
Also at 6 months, 43.8% of patients in the restrictive-threshold group, versus 42.8% in the liberal arm, met the study’s secondary composite outcome, which included the components of the primary outcome plus hospital readmissions, ED visits, and coronary revascularization. The difference was again statistically insignificant.
The restrictive strategy saved a lot of blood. Just over half of the patients, versus almost three-quarters in the liberal arm, were transfused during their index admissions. When transfused, patients in the restrictive arm received a median of 2 units of red cells; liberal-arm patients received a median of 3 units.
Unexpectedly, patients 75 years and older had a lower risk of poor outcomes with the restrictive strategy, while the liberal strategy was associated with lower risk in younger subjects. The findings “appear to contradict” current practice, “in which a liberal transfusion strategy is used in older patients undergoing cardiac or noncardiac surgery,” said investigators led by C. David Mazer, MD, a professor in the department of anesthesia at the University of Toronto.
“One could hypothesize that older patients may have unacceptable adverse effects related to transfusion (e.g., volume overload and inflammatory and infectious complications) or that there may be age-related differences in the adverse-effect profile of transfusion or anemia. ... Whether transfusion thresholds should differ according to age” needs to be determined, they said.
The participants were a mean of 72 years old, and 35% were women. The majority in both arms underwent coronary artery bypass surgery, valve surgery, or both. Heart transplants were excluded. The trial was conducted in 19 countries, including China and India; results were consistent across study sites.
The work was funded by the Canadian Institutes of Health Research, among others. Dr. Mazer had no relevant disclosures.
SOURCE: Mazer CD et al. N Engl J Med. 2018 Aug 26. doi:10.1056/NEJMoa1808561
MUNICH – in a large, randomized trial presented at the annual congress of the European Society of Cardiology, and published simultaneously in the New England Journal of Medicine.
The investigators previously reported that 28 day outcomes were non-inferior with the restrictive approach, but they wanted to look into 6 month results to rule out latent problems, such as sequelae from perioperative organ hypoxia.
The new outcomes from the study, dubbed the Transfusion Requirements in Cardiac Surgery (TRICS) III trial, offer some reassurance at a time when cardiac surgeons are shifting towards more restrictive transfusion policies (N Engl J Med. 2018 Aug 26.doi: 10.1056/NEJMoa1808561).
The trial randomized 2,317 patients to red cell transfusions if their hemoglobin concentrations fell below 7.5 g/dL intraoperatively or postoperatively. Another 2,347 were randomized to the liberal approach, with transfusions below 9.5 g/dL in the operating room and ICU, and below 8.5 g/dL outside of the ICU. The arms were well matched, with a mean score of 8 in both groups on the 47-point European System for Cardiac Operative Risk Evaluation I score.
At 6 months, 17.4% of patients in the restrictive arm, versus 17.1% in the liberal-threshold group, met the primary composite outcome of death from any cause, myocardial infarction, stroke, or new onset renal failure with dialysis (P = .006 for noninferiority with the restrictive threshold); 6.2% of patients in the restrictive-threshold group, versus 6.4% in the liberal-arm, had died at that point, a statistically insignificant difference.
Also at 6 months, 43.8% of patients in the restrictive-threshold group, versus 42.8% in the liberal arm, met the study’s secondary composite outcome, which included the components of the primary outcome plus hospital readmissions, ED visits, and coronary revascularization. The difference was again statistically insignificant.
The restrictive strategy saved a lot of blood. Just over half of the patients, versus almost three-quarters in the liberal arm, were transfused during their index admissions. When transfused, patients in the restrictive arm received a median of 2 units of red cells; liberal-arm patients received a median of 3 units.
Unexpectedly, patients 75 years and older had a lower risk of poor outcomes with the restrictive strategy, while the liberal strategy was associated with lower risk in younger subjects. The findings “appear to contradict” current practice, “in which a liberal transfusion strategy is used in older patients undergoing cardiac or noncardiac surgery,” said investigators led by C. David Mazer, MD, a professor in the department of anesthesia at the University of Toronto.
“One could hypothesize that older patients may have unacceptable adverse effects related to transfusion (e.g., volume overload and inflammatory and infectious complications) or that there may be age-related differences in the adverse-effect profile of transfusion or anemia. ... Whether transfusion thresholds should differ according to age” needs to be determined, they said.
The participants were a mean of 72 years old, and 35% were women. The majority in both arms underwent coronary artery bypass surgery, valve surgery, or both. Heart transplants were excluded. The trial was conducted in 19 countries, including China and India; results were consistent across study sites.
The work was funded by the Canadian Institutes of Health Research, among others. Dr. Mazer had no relevant disclosures.
SOURCE: Mazer CD et al. N Engl J Med. 2018 Aug 26. doi:10.1056/NEJMoa1808561
REPORTING FROM THE ESC CONGRESS 2018
Key clinical point: A restrictive transfusion strategy during cardiovascular surgery, versus a more traditional liberal approach, did not increase the risk of poor outcomes at 6 months.
Major finding: At 6 months, 17.4% of patients in the restrictive arm, versus 17.1% in the liberal-threshold group, met the primary composite outcome of death from any cause, myocardial infarction, stroke, or new onset renal failure with dialysis (P = .006 for noninferiority with the restrictive approach).
Study details: Randomized, multicenter trial with over 5,000 surgery patients
Disclosures: The work was funded by the Canadian Institutes of Health Research, among others. The lead investigator had no relevant disclosures.
Source: Mazer CD et al. N Engl J Med. 2018 Aug 26. doi:10.1056/NEJMoa1808561
More frequent CT surveillance in NSCLC doesn’t improve survival
More even after researchers controlled for tumor histology and recurrence.
Compared with those followed every 3 months, the hazard ratio for 6-month follow-up with CT scanning was 1.16, and 1.06 for annual follow-up – a nonsignificant difference. Nor did more frequent imaging improve survival among the subgroup of patients who were cancer free 9 months after their surgery or among those who had recurrences, Timothy L. McMurry, PhD, and his colleagues reported in the Annals of Surgery. The paper was presented at the annual meeting of the American Surgical Association.
The results probably reflect the very poor survival rates of any patients who develop recurrent non–small cell lung cancer (NSCLC), wrote Dr. McMurry, a biostatistician at the University of Virginia, Charlottesville, and his coauthors.
“Surveillance recommendations need to be considered in the context of potential harms and benefits to patients and their caregivers,” they said. “Follow-up imaging and office visits increase cost and can lead to patient anxiety. Although it seems intuitive that earlier detection of asymptomatic recurrence could improve outcomes, patients with recurrent NSCLC do very poorly … poor survival after recurrence helps explain why more intense surveillance after surgical resection was not associated with improvement in overall survival.”
However, they noted, treatment advances for recurrent and metastatic disease may already be changing the outlook for these patients, “systemic therapy and targeted agents are demonstrating clinically significant survival benefits for small patient subgroups, which, in the future, may augment the benefits of early recurrence detection.”
The team undertook this retrospective study – the largest of its kind in NSCLC patients – in light of current follow-up recommendations that are based almost solely on expert consensus, with low-level data.
“Because there is a paucity of high-quality data on NSCLC surveillance, practice guidelines are based on small retrospective analyses and expert opinion. This results in wide variation in practice including both underuse and overuse of surveillance services.”
The study plumbed the National Cancer Database, extracting information on patients who underwent surgery for NSCLC stages I-III during 2006-2007. All had complete resection and negative margins. Patients were followed through 2012, or until they had a recurrence, a new primary cancer, or they died.
The cohort comprised 4,463 who were followed with CT imaging: 1,614 every 3 months, 1,999 every 6 months, and 850 annually. These intervals correspond to the three different major recommendations. The most common procedure was a lobectomy (about 80%). Patients with higher-stage cancers were significantly more likely to receive more frequent imaging. The regression model controlled for age, sex, comorbidities, tumor stage, and surgical procedure.
After 14 months, 3,552 patients (79.5%) were alive and cancer free. However, during the rest of the follow-up period, 11% developed a new primary cancer and 24% a recurrence of their lung cancer, with no between-group differences. The regression analysis showed no significant difference in recurrence related to surveillance interval, whether 6 months was compared with 3 months (hazard ratio, 1.16) or 1 year with 3 months (HR, 1.06).
Results were much the same for the subgroup of 3,165 who were alive and cancer free 9 months after surgery. In this group, 11% developed a new primary cancer and 29% a recurrence of their lung cancer, with similar numbers in each of the surveillance groups (HR, 1.12 for 6 months vs. 3 months).
Finally, a model including only those who had recurrence, new cancers, or were lost to follow-up within 14 months of surgery also showed no benefit for more frequent surveillance.
“More recent prerecurrence imaging was not associated with postrecurrence survival (HR, 1.02 per month since imaging), and patients who had gone more than 14 months without imaging were at no greater risk of death (HR, 1.01),” the investigators wrote.
The significant predictors of worse survival were nothing surprising, the authors noted. These included symptomatic recurrence (HR, 1.49), distant recurrence, age, male sex, congestive heart failure, coronary artery disease, and peripheral vascular disease.
The findings are not to say, however, that CT surveillance confers no benefit, the authors noted.
“Historically, 5-year survival for the earliest stage of lung cancer, stage IA, was only 70%. Increased use of CT scanning has, however, resulted in a decrease in the median tumor size of resected NSCLC and a shift toward earlier-stage disease. … The National Lung Screening Trial prospectively evaluated annual low-dose screening CT scans and demonstrated a 20% reduction in mortality from lung cancer. This enormous improvement in survival for NSCLC patients provides great promise for the future and is likely to increase the volume of lung cancer resections performed and the number of lung cancer survivors needing routine surveillance.”
However, the data do show that “at least annual CT surveillance is appropriate but that there is no benefit to more than biannual surveillance.”
The authors reported no financial conflicts.
SOURCE: McMurry TL et al. Ann Surg 2018 Jul 12. doi: 10.1097/SLA.0000000000002955.
More even after researchers controlled for tumor histology and recurrence.
Compared with those followed every 3 months, the hazard ratio for 6-month follow-up with CT scanning was 1.16, and 1.06 for annual follow-up – a nonsignificant difference. Nor did more frequent imaging improve survival among the subgroup of patients who were cancer free 9 months after their surgery or among those who had recurrences, Timothy L. McMurry, PhD, and his colleagues reported in the Annals of Surgery. The paper was presented at the annual meeting of the American Surgical Association.
The results probably reflect the very poor survival rates of any patients who develop recurrent non–small cell lung cancer (NSCLC), wrote Dr. McMurry, a biostatistician at the University of Virginia, Charlottesville, and his coauthors.
“Surveillance recommendations need to be considered in the context of potential harms and benefits to patients and their caregivers,” they said. “Follow-up imaging and office visits increase cost and can lead to patient anxiety. Although it seems intuitive that earlier detection of asymptomatic recurrence could improve outcomes, patients with recurrent NSCLC do very poorly … poor survival after recurrence helps explain why more intense surveillance after surgical resection was not associated with improvement in overall survival.”
However, they noted, treatment advances for recurrent and metastatic disease may already be changing the outlook for these patients, “systemic therapy and targeted agents are demonstrating clinically significant survival benefits for small patient subgroups, which, in the future, may augment the benefits of early recurrence detection.”
The team undertook this retrospective study – the largest of its kind in NSCLC patients – in light of current follow-up recommendations that are based almost solely on expert consensus, with low-level data.
“Because there is a paucity of high-quality data on NSCLC surveillance, practice guidelines are based on small retrospective analyses and expert opinion. This results in wide variation in practice including both underuse and overuse of surveillance services.”
The study plumbed the National Cancer Database, extracting information on patients who underwent surgery for NSCLC stages I-III during 2006-2007. All had complete resection and negative margins. Patients were followed through 2012, or until they had a recurrence, a new primary cancer, or they died.
The cohort comprised 4,463 who were followed with CT imaging: 1,614 every 3 months, 1,999 every 6 months, and 850 annually. These intervals correspond to the three different major recommendations. The most common procedure was a lobectomy (about 80%). Patients with higher-stage cancers were significantly more likely to receive more frequent imaging. The regression model controlled for age, sex, comorbidities, tumor stage, and surgical procedure.
After 14 months, 3,552 patients (79.5%) were alive and cancer free. However, during the rest of the follow-up period, 11% developed a new primary cancer and 24% a recurrence of their lung cancer, with no between-group differences. The regression analysis showed no significant difference in recurrence related to surveillance interval, whether 6 months was compared with 3 months (hazard ratio, 1.16) or 1 year with 3 months (HR, 1.06).
Results were much the same for the subgroup of 3,165 who were alive and cancer free 9 months after surgery. In this group, 11% developed a new primary cancer and 29% a recurrence of their lung cancer, with similar numbers in each of the surveillance groups (HR, 1.12 for 6 months vs. 3 months).
Finally, a model including only those who had recurrence, new cancers, or were lost to follow-up within 14 months of surgery also showed no benefit for more frequent surveillance.
“More recent prerecurrence imaging was not associated with postrecurrence survival (HR, 1.02 per month since imaging), and patients who had gone more than 14 months without imaging were at no greater risk of death (HR, 1.01),” the investigators wrote.
The significant predictors of worse survival were nothing surprising, the authors noted. These included symptomatic recurrence (HR, 1.49), distant recurrence, age, male sex, congestive heart failure, coronary artery disease, and peripheral vascular disease.
The findings are not to say, however, that CT surveillance confers no benefit, the authors noted.
“Historically, 5-year survival for the earliest stage of lung cancer, stage IA, was only 70%. Increased use of CT scanning has, however, resulted in a decrease in the median tumor size of resected NSCLC and a shift toward earlier-stage disease. … The National Lung Screening Trial prospectively evaluated annual low-dose screening CT scans and demonstrated a 20% reduction in mortality from lung cancer. This enormous improvement in survival for NSCLC patients provides great promise for the future and is likely to increase the volume of lung cancer resections performed and the number of lung cancer survivors needing routine surveillance.”
However, the data do show that “at least annual CT surveillance is appropriate but that there is no benefit to more than biannual surveillance.”
The authors reported no financial conflicts.
SOURCE: McMurry TL et al. Ann Surg 2018 Jul 12. doi: 10.1097/SLA.0000000000002955.
More even after researchers controlled for tumor histology and recurrence.
Compared with those followed every 3 months, the hazard ratio for 6-month follow-up with CT scanning was 1.16, and 1.06 for annual follow-up – a nonsignificant difference. Nor did more frequent imaging improve survival among the subgroup of patients who were cancer free 9 months after their surgery or among those who had recurrences, Timothy L. McMurry, PhD, and his colleagues reported in the Annals of Surgery. The paper was presented at the annual meeting of the American Surgical Association.
The results probably reflect the very poor survival rates of any patients who develop recurrent non–small cell lung cancer (NSCLC), wrote Dr. McMurry, a biostatistician at the University of Virginia, Charlottesville, and his coauthors.
“Surveillance recommendations need to be considered in the context of potential harms and benefits to patients and their caregivers,” they said. “Follow-up imaging and office visits increase cost and can lead to patient anxiety. Although it seems intuitive that earlier detection of asymptomatic recurrence could improve outcomes, patients with recurrent NSCLC do very poorly … poor survival after recurrence helps explain why more intense surveillance after surgical resection was not associated with improvement in overall survival.”
However, they noted, treatment advances for recurrent and metastatic disease may already be changing the outlook for these patients, “systemic therapy and targeted agents are demonstrating clinically significant survival benefits for small patient subgroups, which, in the future, may augment the benefits of early recurrence detection.”
The team undertook this retrospective study – the largest of its kind in NSCLC patients – in light of current follow-up recommendations that are based almost solely on expert consensus, with low-level data.
“Because there is a paucity of high-quality data on NSCLC surveillance, practice guidelines are based on small retrospective analyses and expert opinion. This results in wide variation in practice including both underuse and overuse of surveillance services.”
The study plumbed the National Cancer Database, extracting information on patients who underwent surgery for NSCLC stages I-III during 2006-2007. All had complete resection and negative margins. Patients were followed through 2012, or until they had a recurrence, a new primary cancer, or they died.
The cohort comprised 4,463 who were followed with CT imaging: 1,614 every 3 months, 1,999 every 6 months, and 850 annually. These intervals correspond to the three different major recommendations. The most common procedure was a lobectomy (about 80%). Patients with higher-stage cancers were significantly more likely to receive more frequent imaging. The regression model controlled for age, sex, comorbidities, tumor stage, and surgical procedure.
After 14 months, 3,552 patients (79.5%) were alive and cancer free. However, during the rest of the follow-up period, 11% developed a new primary cancer and 24% a recurrence of their lung cancer, with no between-group differences. The regression analysis showed no significant difference in recurrence related to surveillance interval, whether 6 months was compared with 3 months (hazard ratio, 1.16) or 1 year with 3 months (HR, 1.06).
Results were much the same for the subgroup of 3,165 who were alive and cancer free 9 months after surgery. In this group, 11% developed a new primary cancer and 29% a recurrence of their lung cancer, with similar numbers in each of the surveillance groups (HR, 1.12 for 6 months vs. 3 months).
Finally, a model including only those who had recurrence, new cancers, or were lost to follow-up within 14 months of surgery also showed no benefit for more frequent surveillance.
“More recent prerecurrence imaging was not associated with postrecurrence survival (HR, 1.02 per month since imaging), and patients who had gone more than 14 months without imaging were at no greater risk of death (HR, 1.01),” the investigators wrote.
The significant predictors of worse survival were nothing surprising, the authors noted. These included symptomatic recurrence (HR, 1.49), distant recurrence, age, male sex, congestive heart failure, coronary artery disease, and peripheral vascular disease.
The findings are not to say, however, that CT surveillance confers no benefit, the authors noted.
“Historically, 5-year survival for the earliest stage of lung cancer, stage IA, was only 70%. Increased use of CT scanning has, however, resulted in a decrease in the median tumor size of resected NSCLC and a shift toward earlier-stage disease. … The National Lung Screening Trial prospectively evaluated annual low-dose screening CT scans and demonstrated a 20% reduction in mortality from lung cancer. This enormous improvement in survival for NSCLC patients provides great promise for the future and is likely to increase the volume of lung cancer resections performed and the number of lung cancer survivors needing routine surveillance.”
However, the data do show that “at least annual CT surveillance is appropriate but that there is no benefit to more than biannual surveillance.”
The authors reported no financial conflicts.
SOURCE: McMurry TL et al. Ann Surg 2018 Jul 12. doi: 10.1097/SLA.0000000000002955.
FROM THE ANNALS OF SURGERY
Key clinical point: More frequent CT surveillance did not improve survival in patients with resected non–small cell lung cancer.
Major finding: Survival among those who got scans every 6 months was not significantly different than every 3 months (HR, 1.16)
Study details: The retrospective study comprised 4,463 patients.
Disclosures: The authors had no financial conflicts.
Source: McMurry TL et al. Ann Surg. 2018 Jul 12. doi: 10.1097/SLA.0000000000002955.
Tuition-free med school touches off multimillion-dollar debate
New York University’s School of Medicine is learning that no good deed goes unpunished.
The highly ranked medical school announced with much fanfare Aug. 16 that it is raising $600 million from private donors to eliminate tuition for all its students – even providing refunds to those currently enrolled. Before the announcement, annual tuition was $55,018.
NYU leaders said the move will help address the increasing problem of student debt among young doctors, which many educators argue pushes students to enter higher-paying specialties instead of primary care, or deters them from becoming doctors in the first place.
“A population as diverse as ours is best served by doctors from all walks of life, we believe, and aspiring physicians and surgeons should not be prevented from pursuing a career in medicine because of the prospect of overwhelming financial debt,” Dr. Robert Grossman, the dean of the medical school and CEO of NYU Langone Health, said in a statement. NYU declined a request to elaborate further on its plans.
“As I start rank ordering the various charities I want to give to, the people who can pay for medical school in cash aren’t at the top of my list,” said Craig Garthwaite, a health economist at Northwestern University’s Kellogg School of Management.
“If you had to find some cause to put tons of money behind, this strikes me as an odd one,” said Dr. Aaron Carroll, a pediatrician and researcher at Indiana University.
Still, medical education debt is a big issue in health care. According to the Association of American Medical Colleges, which represents U.S. medical schools and academic health centers, 75 percent of graduating physicians had student loan debt as they launched their careers, with a median tally of $192,000 in 2017. Nearly half owed more than $200,000.
But it is less clear how much of an impact that debt has on students’ choice of medical specialty. The AAMC’s data suggests debt does not play as big a role in specialty selection as some analysts claim.
If debt were a huge factor, one would expect that doctors who owed the most would choose the highest-paying specialties. But that’s not the case.
“Debt doesn’t vary much across the specialties,” said Julie Fresne, AAMC’s director of student financial services and debt management.
Garthwaite agrees. He said surveys in which young doctors claim debt as a reason for choosing a more lucrative specialty should be viewed with suspicion. “No one [who chooses a higher-paying job] says they did it because they want two Teslas,” he said. “They say they have all this debt.”
Carroll questioned how much difference even $200,000 in student debt makes to people who, at the lowest end of the medical spectrum, still stand to make six figures a year. “Doctors in general do just fine,” he said. “The idea we should pity physicians or worry about them strikes me as odd.”
Choice of specialty is also influenced by more than money. Some specialties may bring less demanding lifestyles than primary care or more prestige. Carroll said his surgeon father was not impressed when he opted for pediatrics, calling it a “garbageman” specialty.
There is also an array of government programs that help students afford medical school or forgive their loans, although usually in exchange for agreeing to serve for several years either in the military or in a medically underserved location. The federal National Health Service Corps, for example, provides scholarships and loan repayments to medical professionals who agree to work in mostly rural or inner-city areas with a shortage of medical professionals. And the Department of Education oversees the Public Service Loan Forgiveness program, which cancels outstanding loan balances after 10 years for those who work for nonprofit employers.
Medical schools themselves are addressing the student debt problem. Many – including NYU – have created programs that let students finish medical school in three years rather than four, which reduces the cost by 25 percent. And the Cleveland Clinic, together with Case Western Reserve University, has a tuition-free medical school aimed at training future medical researchers that takes five years but grants graduates who hold both a doctor of medicine title and a special research credential or master’s degree.
This latest move by NYU, however, is part of a continuing race among top-tier medical schools to attract the best students – and possibly improve their national rankings.
In 2014, UCLA announced it would provide merit-based scholarships covering the entire cost of medical education (including not just tuition, like NYU, but also living expenses) to 20 percent of its students. Columbia University announced a similar plan earlier this year, although unlike NYU and UCLA, Columbia’s program is based on students’ financial need.
The programs are funded, in whole or in part, by large donors whose names brand each medical school – entertainment mogul David Geffen at UCLA, former Merck CEO P. Roy Vagelos at Columbia, and Home Depot co-founder Kenneth Langone at NYU.
Economist Garthwaite said it is all well and good if top medical schools want to compete for top students by offering discounts. But if their goal is to encourage more students to enter primary care or to steer more people from lower-income families into medicine, giving free tuition to all “is not the most target-efficient way to reach that goal.”
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
New York University’s School of Medicine is learning that no good deed goes unpunished.
The highly ranked medical school announced with much fanfare Aug. 16 that it is raising $600 million from private donors to eliminate tuition for all its students – even providing refunds to those currently enrolled. Before the announcement, annual tuition was $55,018.
NYU leaders said the move will help address the increasing problem of student debt among young doctors, which many educators argue pushes students to enter higher-paying specialties instead of primary care, or deters them from becoming doctors in the first place.
“A population as diverse as ours is best served by doctors from all walks of life, we believe, and aspiring physicians and surgeons should not be prevented from pursuing a career in medicine because of the prospect of overwhelming financial debt,” Dr. Robert Grossman, the dean of the medical school and CEO of NYU Langone Health, said in a statement. NYU declined a request to elaborate further on its plans.
“As I start rank ordering the various charities I want to give to, the people who can pay for medical school in cash aren’t at the top of my list,” said Craig Garthwaite, a health economist at Northwestern University’s Kellogg School of Management.
“If you had to find some cause to put tons of money behind, this strikes me as an odd one,” said Dr. Aaron Carroll, a pediatrician and researcher at Indiana University.
Still, medical education debt is a big issue in health care. According to the Association of American Medical Colleges, which represents U.S. medical schools and academic health centers, 75 percent of graduating physicians had student loan debt as they launched their careers, with a median tally of $192,000 in 2017. Nearly half owed more than $200,000.
But it is less clear how much of an impact that debt has on students’ choice of medical specialty. The AAMC’s data suggests debt does not play as big a role in specialty selection as some analysts claim.
If debt were a huge factor, one would expect that doctors who owed the most would choose the highest-paying specialties. But that’s not the case.
“Debt doesn’t vary much across the specialties,” said Julie Fresne, AAMC’s director of student financial services and debt management.
Garthwaite agrees. He said surveys in which young doctors claim debt as a reason for choosing a more lucrative specialty should be viewed with suspicion. “No one [who chooses a higher-paying job] says they did it because they want two Teslas,” he said. “They say they have all this debt.”
Carroll questioned how much difference even $200,000 in student debt makes to people who, at the lowest end of the medical spectrum, still stand to make six figures a year. “Doctors in general do just fine,” he said. “The idea we should pity physicians or worry about them strikes me as odd.”
Choice of specialty is also influenced by more than money. Some specialties may bring less demanding lifestyles than primary care or more prestige. Carroll said his surgeon father was not impressed when he opted for pediatrics, calling it a “garbageman” specialty.
There is also an array of government programs that help students afford medical school or forgive their loans, although usually in exchange for agreeing to serve for several years either in the military or in a medically underserved location. The federal National Health Service Corps, for example, provides scholarships and loan repayments to medical professionals who agree to work in mostly rural or inner-city areas with a shortage of medical professionals. And the Department of Education oversees the Public Service Loan Forgiveness program, which cancels outstanding loan balances after 10 years for those who work for nonprofit employers.
Medical schools themselves are addressing the student debt problem. Many – including NYU – have created programs that let students finish medical school in three years rather than four, which reduces the cost by 25 percent. And the Cleveland Clinic, together with Case Western Reserve University, has a tuition-free medical school aimed at training future medical researchers that takes five years but grants graduates who hold both a doctor of medicine title and a special research credential or master’s degree.
This latest move by NYU, however, is part of a continuing race among top-tier medical schools to attract the best students – and possibly improve their national rankings.
In 2014, UCLA announced it would provide merit-based scholarships covering the entire cost of medical education (including not just tuition, like NYU, but also living expenses) to 20 percent of its students. Columbia University announced a similar plan earlier this year, although unlike NYU and UCLA, Columbia’s program is based on students’ financial need.
The programs are funded, in whole or in part, by large donors whose names brand each medical school – entertainment mogul David Geffen at UCLA, former Merck CEO P. Roy Vagelos at Columbia, and Home Depot co-founder Kenneth Langone at NYU.
Economist Garthwaite said it is all well and good if top medical schools want to compete for top students by offering discounts. But if their goal is to encourage more students to enter primary care or to steer more people from lower-income families into medicine, giving free tuition to all “is not the most target-efficient way to reach that goal.”
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
New York University’s School of Medicine is learning that no good deed goes unpunished.
The highly ranked medical school announced with much fanfare Aug. 16 that it is raising $600 million from private donors to eliminate tuition for all its students – even providing refunds to those currently enrolled. Before the announcement, annual tuition was $55,018.
NYU leaders said the move will help address the increasing problem of student debt among young doctors, which many educators argue pushes students to enter higher-paying specialties instead of primary care, or deters them from becoming doctors in the first place.
“A population as diverse as ours is best served by doctors from all walks of life, we believe, and aspiring physicians and surgeons should not be prevented from pursuing a career in medicine because of the prospect of overwhelming financial debt,” Dr. Robert Grossman, the dean of the medical school and CEO of NYU Langone Health, said in a statement. NYU declined a request to elaborate further on its plans.
“As I start rank ordering the various charities I want to give to, the people who can pay for medical school in cash aren’t at the top of my list,” said Craig Garthwaite, a health economist at Northwestern University’s Kellogg School of Management.
“If you had to find some cause to put tons of money behind, this strikes me as an odd one,” said Dr. Aaron Carroll, a pediatrician and researcher at Indiana University.
Still, medical education debt is a big issue in health care. According to the Association of American Medical Colleges, which represents U.S. medical schools and academic health centers, 75 percent of graduating physicians had student loan debt as they launched their careers, with a median tally of $192,000 in 2017. Nearly half owed more than $200,000.
But it is less clear how much of an impact that debt has on students’ choice of medical specialty. The AAMC’s data suggests debt does not play as big a role in specialty selection as some analysts claim.
If debt were a huge factor, one would expect that doctors who owed the most would choose the highest-paying specialties. But that’s not the case.
“Debt doesn’t vary much across the specialties,” said Julie Fresne, AAMC’s director of student financial services and debt management.
Garthwaite agrees. He said surveys in which young doctors claim debt as a reason for choosing a more lucrative specialty should be viewed with suspicion. “No one [who chooses a higher-paying job] says they did it because they want two Teslas,” he said. “They say they have all this debt.”
Carroll questioned how much difference even $200,000 in student debt makes to people who, at the lowest end of the medical spectrum, still stand to make six figures a year. “Doctors in general do just fine,” he said. “The idea we should pity physicians or worry about them strikes me as odd.”
Choice of specialty is also influenced by more than money. Some specialties may bring less demanding lifestyles than primary care or more prestige. Carroll said his surgeon father was not impressed when he opted for pediatrics, calling it a “garbageman” specialty.
There is also an array of government programs that help students afford medical school or forgive their loans, although usually in exchange for agreeing to serve for several years either in the military or in a medically underserved location. The federal National Health Service Corps, for example, provides scholarships and loan repayments to medical professionals who agree to work in mostly rural or inner-city areas with a shortage of medical professionals. And the Department of Education oversees the Public Service Loan Forgiveness program, which cancels outstanding loan balances after 10 years for those who work for nonprofit employers.
Medical schools themselves are addressing the student debt problem. Many – including NYU – have created programs that let students finish medical school in three years rather than four, which reduces the cost by 25 percent. And the Cleveland Clinic, together with Case Western Reserve University, has a tuition-free medical school aimed at training future medical researchers that takes five years but grants graduates who hold both a doctor of medicine title and a special research credential or master’s degree.
This latest move by NYU, however, is part of a continuing race among top-tier medical schools to attract the best students – and possibly improve their national rankings.
In 2014, UCLA announced it would provide merit-based scholarships covering the entire cost of medical education (including not just tuition, like NYU, but also living expenses) to 20 percent of its students. Columbia University announced a similar plan earlier this year, although unlike NYU and UCLA, Columbia’s program is based on students’ financial need.
The programs are funded, in whole or in part, by large donors whose names brand each medical school – entertainment mogul David Geffen at UCLA, former Merck CEO P. Roy Vagelos at Columbia, and Home Depot co-founder Kenneth Langone at NYU.
Economist Garthwaite said it is all well and good if top medical schools want to compete for top students by offering discounts. But if their goal is to encourage more students to enter primary care or to steer more people from lower-income families into medicine, giving free tuition to all “is not the most target-efficient way to reach that goal.”
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Prealbumin level predicts outcomes for HCC resection
Preoperative prealbumin levels independently predicted survival after curative liver resection for hepatocellular carcinoma (HCC) in a recent multicenter, retrospective study.
By contrast, preoperative albumin levels did not predict long-term overall or relapse-free survival in the analysis, which was reported by Tian Yang, MD, and Feng Shen, MD, along with their coinvestigators, in the journal HPB.
Those findings suggest that serum prealbumin is superior to the widely used serum albumin level as a marker of nutritional status and liver function in this setting, according to Dr. Yang and Dr. Shen, who are with the department of hepatobiliary surgery at Eastern Hepatobiliary Surgery Hospital, Shanghai, China.
“The importance of preoperative prealbumin level in predicting long-term prognosis after liver resection for HCC should be given adequate attention by hepatic surgeons,” they wrote in their report.
The retrospective analysis included a total of 1,483 patients with HCC newly diagnosed at one of six medical institutions in China during 2001-2014. Of those patients, 1,046 (71%) had normal prealbumin levels (above 170 mg/L) measured within a week before surgery, while the remaining 437 (29%) had low prealbumin levels.
Overall survival was a mean of 72 months for the low prealbumin group versus 99 months for the normal prealbumin group (P less than .001), with a corresponding 5-year overall survival of 31% versus 43%, respectively, investigators reported
Likewise, relapse-free survival was a mean of 56 months for the low prealbumin group versus 77 months for the normal prealbumin groups (P less than .001), with 5-year relapse-free survival rates of 20% and 28%, respectively.
In multivariable Cox-regression analyses, the hazard ratios of low preoperative prealbumin level for risk of decreased overall survival and for risk of decreased relapse-free survival were 1.45 (95% confidence interval, 1.24-1.70) and 1.28 (95% CI, 1.10-1.48), respectively.
By contrast, preoperative albumin level was not an independent predictor of either overall or relapse-free survival in multivariate analyses, according to investigators.
Despite these findings, it remains controversial as to which marker is more accurate as a measure of nutritional status, investigators wrote in their report.
While albumin is more commonly used in clinical practice, they explained, multiple studies have shown prealbumin is more specific and sensitive in evaluating protein malnutrition and liver function.
The present study, although retrospective, is multicenter, has a large sample size, and includes adequately long follow-up. Nevertheless, further studies will be required to determine whether prealbumin could replace albumin for assessments of nutritional status and liver function after curative liver resection for HCC, investigators concluded.
The research was supported in part by the National Natural Science Foundation of China and the Shanghai Pujiang Program. Dr. Yang, Dr. Shen, and their coauthors had no conflicts of interest to disclose.
SOURCE: Li J-D et al. HPB (Oxford). 2018 Aug 3. doi: 10.1016/j.hpb.2018.06.1803.
Preoperative prealbumin levels independently predicted survival after curative liver resection for hepatocellular carcinoma (HCC) in a recent multicenter, retrospective study.
By contrast, preoperative albumin levels did not predict long-term overall or relapse-free survival in the analysis, which was reported by Tian Yang, MD, and Feng Shen, MD, along with their coinvestigators, in the journal HPB.
Those findings suggest that serum prealbumin is superior to the widely used serum albumin level as a marker of nutritional status and liver function in this setting, according to Dr. Yang and Dr. Shen, who are with the department of hepatobiliary surgery at Eastern Hepatobiliary Surgery Hospital, Shanghai, China.
“The importance of preoperative prealbumin level in predicting long-term prognosis after liver resection for HCC should be given adequate attention by hepatic surgeons,” they wrote in their report.
The retrospective analysis included a total of 1,483 patients with HCC newly diagnosed at one of six medical institutions in China during 2001-2014. Of those patients, 1,046 (71%) had normal prealbumin levels (above 170 mg/L) measured within a week before surgery, while the remaining 437 (29%) had low prealbumin levels.
Overall survival was a mean of 72 months for the low prealbumin group versus 99 months for the normal prealbumin group (P less than .001), with a corresponding 5-year overall survival of 31% versus 43%, respectively, investigators reported
Likewise, relapse-free survival was a mean of 56 months for the low prealbumin group versus 77 months for the normal prealbumin groups (P less than .001), with 5-year relapse-free survival rates of 20% and 28%, respectively.
In multivariable Cox-regression analyses, the hazard ratios of low preoperative prealbumin level for risk of decreased overall survival and for risk of decreased relapse-free survival were 1.45 (95% confidence interval, 1.24-1.70) and 1.28 (95% CI, 1.10-1.48), respectively.
By contrast, preoperative albumin level was not an independent predictor of either overall or relapse-free survival in multivariate analyses, according to investigators.
Despite these findings, it remains controversial as to which marker is more accurate as a measure of nutritional status, investigators wrote in their report.
While albumin is more commonly used in clinical practice, they explained, multiple studies have shown prealbumin is more specific and sensitive in evaluating protein malnutrition and liver function.
The present study, although retrospective, is multicenter, has a large sample size, and includes adequately long follow-up. Nevertheless, further studies will be required to determine whether prealbumin could replace albumin for assessments of nutritional status and liver function after curative liver resection for HCC, investigators concluded.
The research was supported in part by the National Natural Science Foundation of China and the Shanghai Pujiang Program. Dr. Yang, Dr. Shen, and their coauthors had no conflicts of interest to disclose.
SOURCE: Li J-D et al. HPB (Oxford). 2018 Aug 3. doi: 10.1016/j.hpb.2018.06.1803.
Preoperative prealbumin levels independently predicted survival after curative liver resection for hepatocellular carcinoma (HCC) in a recent multicenter, retrospective study.
By contrast, preoperative albumin levels did not predict long-term overall or relapse-free survival in the analysis, which was reported by Tian Yang, MD, and Feng Shen, MD, along with their coinvestigators, in the journal HPB.
Those findings suggest that serum prealbumin is superior to the widely used serum albumin level as a marker of nutritional status and liver function in this setting, according to Dr. Yang and Dr. Shen, who are with the department of hepatobiliary surgery at Eastern Hepatobiliary Surgery Hospital, Shanghai, China.
“The importance of preoperative prealbumin level in predicting long-term prognosis after liver resection for HCC should be given adequate attention by hepatic surgeons,” they wrote in their report.
The retrospective analysis included a total of 1,483 patients with HCC newly diagnosed at one of six medical institutions in China during 2001-2014. Of those patients, 1,046 (71%) had normal prealbumin levels (above 170 mg/L) measured within a week before surgery, while the remaining 437 (29%) had low prealbumin levels.
Overall survival was a mean of 72 months for the low prealbumin group versus 99 months for the normal prealbumin group (P less than .001), with a corresponding 5-year overall survival of 31% versus 43%, respectively, investigators reported
Likewise, relapse-free survival was a mean of 56 months for the low prealbumin group versus 77 months for the normal prealbumin groups (P less than .001), with 5-year relapse-free survival rates of 20% and 28%, respectively.
In multivariable Cox-regression analyses, the hazard ratios of low preoperative prealbumin level for risk of decreased overall survival and for risk of decreased relapse-free survival were 1.45 (95% confidence interval, 1.24-1.70) and 1.28 (95% CI, 1.10-1.48), respectively.
By contrast, preoperative albumin level was not an independent predictor of either overall or relapse-free survival in multivariate analyses, according to investigators.
Despite these findings, it remains controversial as to which marker is more accurate as a measure of nutritional status, investigators wrote in their report.
While albumin is more commonly used in clinical practice, they explained, multiple studies have shown prealbumin is more specific and sensitive in evaluating protein malnutrition and liver function.
The present study, although retrospective, is multicenter, has a large sample size, and includes adequately long follow-up. Nevertheless, further studies will be required to determine whether prealbumin could replace albumin for assessments of nutritional status and liver function after curative liver resection for HCC, investigators concluded.
The research was supported in part by the National Natural Science Foundation of China and the Shanghai Pujiang Program. Dr. Yang, Dr. Shen, and their coauthors had no conflicts of interest to disclose.
SOURCE: Li J-D et al. HPB (Oxford). 2018 Aug 3. doi: 10.1016/j.hpb.2018.06.1803.
FROM HPB
Key clinical point: Preoperative prealbumin levels independently predicted survival after curative liver resection for HCC, while preoperative albumin levels did not.
Major finding: The hazard ratios of low preoperative prealbumin level for risk of decreased overall survival and for risk of decreased relapse-free survival were 1.45 (95% confidence interval, 1.24-1.70) and 1.28 (95% CI, 1.10-1.48), respectively.
Study details: Retrospective analysis that included 1,483 patients with HCC newly diagnosed at one of six institutions in China during 2001-2014.
Disclosures: The research was supported in part by the National Natural Science Foundation of China and the Shanghai Pujiang Program. The study authors had no conflicts of interest to disclose.
Source: Li J-D et al. HPB (Oxford). 2018 Aug 3. doi: 10.1016/j.hpb.2018.06.1803.