FVC deterioration signals increasing risk in rib fracture patients

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Deteriorating forced vital capacity (FVC) levels predict heightened risk of complications in rib fracture patients, according to a study presented at the annual scientific assembly Eastern Association for the Surgery of Trauma.

Daily, easily conducted, bedside FVC monitoring can help identify the first signs of a worsening condition and lead to earlier intervention, according to presenter Rachel Warner, DO, a surgical resident at West Virginia University, Morgantown.

“Unplanned upgrades to the ICU have been associated with prolonged hospital stay, mechanical ventilation, and even higher risk of mortality when compared to planned upgrades,” Dr. Warner explained. “We aim to decrease these events by creating a system where early decline can be recognized by any member of the health care team.”

In a retrospective study, investigators analyzed 1,106 rib fracture patients enrolled in a rib fracture care pathway at a Level I trauma center during 2009-2014, all of whom were admitted with an FVC greater than 1 L. Patients’ FVCs were assessed with spirometry in the ED, and the results were then used to determine their care placement. Then FVC was continually monitored throughout each patient’s stay at the hospital. The investigators hypothesized that those patients whose FVC level deteriorated to lower than 1 L were at higher risk for complications.

Two groups of patients were analyzed: Group A was composed of patients whose initial FVC scores were greater than or equal to 1 but deteriorated over time to below 1, while Group B was composed of patients whose scores remained above 1. Group A patients were an average age 58 years and were majority male (61%); their had FVC scores initially averaged 1.3 but dropped to a low of 0.7. Patients in group B were on average younger, at 48 years, but also majority male (79%); they had a slightly higher initial average FVC of 1.6, with a low of 1.4.

Rate of complications among patients whose FVC scores dropped below 1 was 15%, compared with 3.2% in the other group (P less than .001).

Group A patients were significantly more likely than were Group B patients to develop pneumonia (9% vs. 4%, respectively), be upgraded to the intensive care unit (3.7% vs. 0.2%), require intubation (1.6% vs. 0.1%), or be readmitted (4% vs. 1%).

Average length of stay for patients whose FVC score dropped below 1 was 10 days, compared with 4 days among the patients who maintained a higher FVC. Mortality rates were also significantly higher at 3%, compared with 0.2%. Dr. Warner said that FVC levels can be the first indication of worsening clinical status and should be treated as an early warning sign for which patients may need to be preemptively moved to a higher level of care.

Dr. Warner and her colleagues were limited by the retrospective nature of their analysis, as well as not including other injuries into their analysis.

In a discussion of the study, Bryce R.H. Robinson, MD, FACS, of Harborview Medical Center, Seattle, Wash., supported using data such as FVC to help identify at-risk patients early. “I am encouraged to see others utilize easily obtainable, objective measures for those at risk for pulmonary decompensation with rib fractures,” said Dr. Robinson.

While keeping the cutoff at 1 L for FVC testing regardless of other factors, like sex or weight, would make it easy to train all members of the medical team, this may be oversimplifying FVC measurements, cautioned Dr. Robinson.

“While it is a little bit less specific to the patient, broad adaptation across the health care team is much more feasible with standard values,” responded Dr. Warner. “Given this, we do intentionally accept a level of overtriaged patients. We have found these patients generally make up the geriatric population and have confounding factors that would otherwise make them high risk for complications.”

Investigators reported no relevant financial disclosures.
 

SOURCE: Warner R et al. EAST Scientific Assembly 2018 abstract #9

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Deteriorating forced vital capacity (FVC) levels predict heightened risk of complications in rib fracture patients, according to a study presented at the annual scientific assembly Eastern Association for the Surgery of Trauma.

Daily, easily conducted, bedside FVC monitoring can help identify the first signs of a worsening condition and lead to earlier intervention, according to presenter Rachel Warner, DO, a surgical resident at West Virginia University, Morgantown.

“Unplanned upgrades to the ICU have been associated with prolonged hospital stay, mechanical ventilation, and even higher risk of mortality when compared to planned upgrades,” Dr. Warner explained. “We aim to decrease these events by creating a system where early decline can be recognized by any member of the health care team.”

In a retrospective study, investigators analyzed 1,106 rib fracture patients enrolled in a rib fracture care pathway at a Level I trauma center during 2009-2014, all of whom were admitted with an FVC greater than 1 L. Patients’ FVCs were assessed with spirometry in the ED, and the results were then used to determine their care placement. Then FVC was continually monitored throughout each patient’s stay at the hospital. The investigators hypothesized that those patients whose FVC level deteriorated to lower than 1 L were at higher risk for complications.

Two groups of patients were analyzed: Group A was composed of patients whose initial FVC scores were greater than or equal to 1 but deteriorated over time to below 1, while Group B was composed of patients whose scores remained above 1. Group A patients were an average age 58 years and were majority male (61%); their had FVC scores initially averaged 1.3 but dropped to a low of 0.7. Patients in group B were on average younger, at 48 years, but also majority male (79%); they had a slightly higher initial average FVC of 1.6, with a low of 1.4.

Rate of complications among patients whose FVC scores dropped below 1 was 15%, compared with 3.2% in the other group (P less than .001).

Group A patients were significantly more likely than were Group B patients to develop pneumonia (9% vs. 4%, respectively), be upgraded to the intensive care unit (3.7% vs. 0.2%), require intubation (1.6% vs. 0.1%), or be readmitted (4% vs. 1%).

Average length of stay for patients whose FVC score dropped below 1 was 10 days, compared with 4 days among the patients who maintained a higher FVC. Mortality rates were also significantly higher at 3%, compared with 0.2%. Dr. Warner said that FVC levels can be the first indication of worsening clinical status and should be treated as an early warning sign for which patients may need to be preemptively moved to a higher level of care.

Dr. Warner and her colleagues were limited by the retrospective nature of their analysis, as well as not including other injuries into their analysis.

In a discussion of the study, Bryce R.H. Robinson, MD, FACS, of Harborview Medical Center, Seattle, Wash., supported using data such as FVC to help identify at-risk patients early. “I am encouraged to see others utilize easily obtainable, objective measures for those at risk for pulmonary decompensation with rib fractures,” said Dr. Robinson.

While keeping the cutoff at 1 L for FVC testing regardless of other factors, like sex or weight, would make it easy to train all members of the medical team, this may be oversimplifying FVC measurements, cautioned Dr. Robinson.

“While it is a little bit less specific to the patient, broad adaptation across the health care team is much more feasible with standard values,” responded Dr. Warner. “Given this, we do intentionally accept a level of overtriaged patients. We have found these patients generally make up the geriatric population and have confounding factors that would otherwise make them high risk for complications.”

Investigators reported no relevant financial disclosures.
 

SOURCE: Warner R et al. EAST Scientific Assembly 2018 abstract #9

 

Deteriorating forced vital capacity (FVC) levels predict heightened risk of complications in rib fracture patients, according to a study presented at the annual scientific assembly Eastern Association for the Surgery of Trauma.

Daily, easily conducted, bedside FVC monitoring can help identify the first signs of a worsening condition and lead to earlier intervention, according to presenter Rachel Warner, DO, a surgical resident at West Virginia University, Morgantown.

“Unplanned upgrades to the ICU have been associated with prolonged hospital stay, mechanical ventilation, and even higher risk of mortality when compared to planned upgrades,” Dr. Warner explained. “We aim to decrease these events by creating a system where early decline can be recognized by any member of the health care team.”

In a retrospective study, investigators analyzed 1,106 rib fracture patients enrolled in a rib fracture care pathway at a Level I trauma center during 2009-2014, all of whom were admitted with an FVC greater than 1 L. Patients’ FVCs were assessed with spirometry in the ED, and the results were then used to determine their care placement. Then FVC was continually monitored throughout each patient’s stay at the hospital. The investigators hypothesized that those patients whose FVC level deteriorated to lower than 1 L were at higher risk for complications.

Two groups of patients were analyzed: Group A was composed of patients whose initial FVC scores were greater than or equal to 1 but deteriorated over time to below 1, while Group B was composed of patients whose scores remained above 1. Group A patients were an average age 58 years and were majority male (61%); their had FVC scores initially averaged 1.3 but dropped to a low of 0.7. Patients in group B were on average younger, at 48 years, but also majority male (79%); they had a slightly higher initial average FVC of 1.6, with a low of 1.4.

Rate of complications among patients whose FVC scores dropped below 1 was 15%, compared with 3.2% in the other group (P less than .001).

Group A patients were significantly more likely than were Group B patients to develop pneumonia (9% vs. 4%, respectively), be upgraded to the intensive care unit (3.7% vs. 0.2%), require intubation (1.6% vs. 0.1%), or be readmitted (4% vs. 1%).

Average length of stay for patients whose FVC score dropped below 1 was 10 days, compared with 4 days among the patients who maintained a higher FVC. Mortality rates were also significantly higher at 3%, compared with 0.2%. Dr. Warner said that FVC levels can be the first indication of worsening clinical status and should be treated as an early warning sign for which patients may need to be preemptively moved to a higher level of care.

Dr. Warner and her colleagues were limited by the retrospective nature of their analysis, as well as not including other injuries into their analysis.

In a discussion of the study, Bryce R.H. Robinson, MD, FACS, of Harborview Medical Center, Seattle, Wash., supported using data such as FVC to help identify at-risk patients early. “I am encouraged to see others utilize easily obtainable, objective measures for those at risk for pulmonary decompensation with rib fractures,” said Dr. Robinson.

While keeping the cutoff at 1 L for FVC testing regardless of other factors, like sex or weight, would make it easy to train all members of the medical team, this may be oversimplifying FVC measurements, cautioned Dr. Robinson.

“While it is a little bit less specific to the patient, broad adaptation across the health care team is much more feasible with standard values,” responded Dr. Warner. “Given this, we do intentionally accept a level of overtriaged patients. We have found these patients generally make up the geriatric population and have confounding factors that would otherwise make them high risk for complications.”

Investigators reported no relevant financial disclosures.
 

SOURCE: Warner R et al. EAST Scientific Assembly 2018 abstract #9

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Key clinical point: Rib fracture patients with FVC below 1 are at higher risk for pulmonary complications.

Major finding: Rate of pulmonary complications was 15% among patients with FVC under 1, compared to 3% in patients with FVC above 1 (P less than .001).

Study details: Retrospective study of 1,106 patients enrolled at a Level I trauma center from 2009 through 2014.

Disclosures: Presenters reported no relevant financial disclosures.

Source: Warner R et al. EAST Scientific Assembly 2018 abstract #9.

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Waiving Medicare coinsurance for positive colorectal screening likely beneficial

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Thu, 03/28/2019 - 14:43

 

Waiving coinsurance for Medicare beneficiaries who have a screening colonoscopy when it results in a polyp removal or follows a positive fecal screening test would likely have a favorable balance of health and cost impact.

Currently, Medicare covers colorectal screening at no charge to the patient, but if a polyp is removed upon discovery during the procedure, the patient would then be subject to Medicare’s coinsurance payments for both the colonoscopy and the removal.

utah778/Thinkstock
“We estimated that waiving coinsurance would be cost-effective if screening rates increased from 60.0% to 60.6%, assuming a willingness-to-pay threshold of $50,000 per QALY [quality-adjusted life-year] gained – which suggests that the waiver would likely have a very favorable balance of health and cost impact,” Elisabeth F.P. Peterse, of Erasmus University Medical Center, Rotterdam, The Netherlands, and her colleagues wrote in new research appearing in the December 2017 issue of Health Affairs.

Researchers used the Microsimulation Screening Analysis-Colon model to estimate the cost-effectiveness of waiving coinsurance for every component of colorectal cancer screening. They estimated that, currently, using the colonoscopy regimen with coinsurance, 12.8 colorectal cancer deaths occurred per 1,000 people aged 65 years and 124.1 QALYs were gained per 1,000 people aged 65 years. The total number of procedures per 1,000 Medicare beneficiaries was 1,132, of which 410 (36%) were potentially subject to coinsurance requirements.

“We estimated that the total lifetime costs for [the Centers for Medicare & Medicaid], which included colorectal cancer screening, surveillance, and treatment with coinsurance, to be $2.675 million per 1,000 sixty-five-year-olds,” Ms. Peterse and her colleagues wrote.

Researchers noted that if the coinsurance was waived but there was no follow-on increase in the screening rate, the benefits of screening would not change but the total cost of screening and treatment would increase to $2.726 million per 1,000 people aged 65 years.

However, “an assumed 5-percentage-point increase in the rates of first colonoscopy screening and surveillance decreased the number of colorectal cancer deaths by 0.9 (6.4 percent), accompanied by an increase of $33,000 (1.2 percent) in total costs, with a cost per QALY gained (or cost-effectiveness ratio) of $4,086.”

They added that estimated screening benefits were similar when fecal testing was the primary screening method.

“In general, [fecal testing] screening was associated with lower number of procedures subject to coinsurance,” the researchers added. “If [fecal testing] screening becomes more popular in the United States, following trends observed in several settings, the costs of waiving coinsurance would be even lower.” The researchers also suggest that it could lead to reducing disparities of colorectal cancer in the United States as well.

AGA has been working for years to try to fix this issue, and supports the bipartisan Removing Barriers to Screening Act, which would correct this inequity for Medicare beneficiaries and remove the financial barriers that may prevent a patient from undergoing a screening. AGA is hopeful that the growing support for the legislation on both sides of the aisle will help get the bill passed this year. To learn more about this issue, visit http://www.gastro.org/take-action/top-issues/patient-cost-sharing-for-screening-colonoscopy. To help your patient understand this issue, AGA has created “What to Expect: Paying for Your Colonoscopy,” which can be downloaded at http://www.gastro.org/patient-care/procedures/Colonoscopy_CoPay_WhatToKnowFactSheet.pdf to be shared in your office. /p>

SOURCE: Peterse EFP et al. Health Affairs. 2017 Dec;36(12):2151-9.

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Waiving coinsurance for Medicare beneficiaries who have a screening colonoscopy when it results in a polyp removal or follows a positive fecal screening test would likely have a favorable balance of health and cost impact.

Currently, Medicare covers colorectal screening at no charge to the patient, but if a polyp is removed upon discovery during the procedure, the patient would then be subject to Medicare’s coinsurance payments for both the colonoscopy and the removal.

utah778/Thinkstock
“We estimated that waiving coinsurance would be cost-effective if screening rates increased from 60.0% to 60.6%, assuming a willingness-to-pay threshold of $50,000 per QALY [quality-adjusted life-year] gained – which suggests that the waiver would likely have a very favorable balance of health and cost impact,” Elisabeth F.P. Peterse, of Erasmus University Medical Center, Rotterdam, The Netherlands, and her colleagues wrote in new research appearing in the December 2017 issue of Health Affairs.

Researchers used the Microsimulation Screening Analysis-Colon model to estimate the cost-effectiveness of waiving coinsurance for every component of colorectal cancer screening. They estimated that, currently, using the colonoscopy regimen with coinsurance, 12.8 colorectal cancer deaths occurred per 1,000 people aged 65 years and 124.1 QALYs were gained per 1,000 people aged 65 years. The total number of procedures per 1,000 Medicare beneficiaries was 1,132, of which 410 (36%) were potentially subject to coinsurance requirements.

“We estimated that the total lifetime costs for [the Centers for Medicare & Medicaid], which included colorectal cancer screening, surveillance, and treatment with coinsurance, to be $2.675 million per 1,000 sixty-five-year-olds,” Ms. Peterse and her colleagues wrote.

Researchers noted that if the coinsurance was waived but there was no follow-on increase in the screening rate, the benefits of screening would not change but the total cost of screening and treatment would increase to $2.726 million per 1,000 people aged 65 years.

However, “an assumed 5-percentage-point increase in the rates of first colonoscopy screening and surveillance decreased the number of colorectal cancer deaths by 0.9 (6.4 percent), accompanied by an increase of $33,000 (1.2 percent) in total costs, with a cost per QALY gained (or cost-effectiveness ratio) of $4,086.”

They added that estimated screening benefits were similar when fecal testing was the primary screening method.

“In general, [fecal testing] screening was associated with lower number of procedures subject to coinsurance,” the researchers added. “If [fecal testing] screening becomes more popular in the United States, following trends observed in several settings, the costs of waiving coinsurance would be even lower.” The researchers also suggest that it could lead to reducing disparities of colorectal cancer in the United States as well.

AGA has been working for years to try to fix this issue, and supports the bipartisan Removing Barriers to Screening Act, which would correct this inequity for Medicare beneficiaries and remove the financial barriers that may prevent a patient from undergoing a screening. AGA is hopeful that the growing support for the legislation on both sides of the aisle will help get the bill passed this year. To learn more about this issue, visit http://www.gastro.org/take-action/top-issues/patient-cost-sharing-for-screening-colonoscopy. To help your patient understand this issue, AGA has created “What to Expect: Paying for Your Colonoscopy,” which can be downloaded at http://www.gastro.org/patient-care/procedures/Colonoscopy_CoPay_WhatToKnowFactSheet.pdf to be shared in your office. /p>

SOURCE: Peterse EFP et al. Health Affairs. 2017 Dec;36(12):2151-9.

 

Waiving coinsurance for Medicare beneficiaries who have a screening colonoscopy when it results in a polyp removal or follows a positive fecal screening test would likely have a favorable balance of health and cost impact.

Currently, Medicare covers colorectal screening at no charge to the patient, but if a polyp is removed upon discovery during the procedure, the patient would then be subject to Medicare’s coinsurance payments for both the colonoscopy and the removal.

utah778/Thinkstock
“We estimated that waiving coinsurance would be cost-effective if screening rates increased from 60.0% to 60.6%, assuming a willingness-to-pay threshold of $50,000 per QALY [quality-adjusted life-year] gained – which suggests that the waiver would likely have a very favorable balance of health and cost impact,” Elisabeth F.P. Peterse, of Erasmus University Medical Center, Rotterdam, The Netherlands, and her colleagues wrote in new research appearing in the December 2017 issue of Health Affairs.

Researchers used the Microsimulation Screening Analysis-Colon model to estimate the cost-effectiveness of waiving coinsurance for every component of colorectal cancer screening. They estimated that, currently, using the colonoscopy regimen with coinsurance, 12.8 colorectal cancer deaths occurred per 1,000 people aged 65 years and 124.1 QALYs were gained per 1,000 people aged 65 years. The total number of procedures per 1,000 Medicare beneficiaries was 1,132, of which 410 (36%) were potentially subject to coinsurance requirements.

“We estimated that the total lifetime costs for [the Centers for Medicare & Medicaid], which included colorectal cancer screening, surveillance, and treatment with coinsurance, to be $2.675 million per 1,000 sixty-five-year-olds,” Ms. Peterse and her colleagues wrote.

Researchers noted that if the coinsurance was waived but there was no follow-on increase in the screening rate, the benefits of screening would not change but the total cost of screening and treatment would increase to $2.726 million per 1,000 people aged 65 years.

However, “an assumed 5-percentage-point increase in the rates of first colonoscopy screening and surveillance decreased the number of colorectal cancer deaths by 0.9 (6.4 percent), accompanied by an increase of $33,000 (1.2 percent) in total costs, with a cost per QALY gained (or cost-effectiveness ratio) of $4,086.”

They added that estimated screening benefits were similar when fecal testing was the primary screening method.

“In general, [fecal testing] screening was associated with lower number of procedures subject to coinsurance,” the researchers added. “If [fecal testing] screening becomes more popular in the United States, following trends observed in several settings, the costs of waiving coinsurance would be even lower.” The researchers also suggest that it could lead to reducing disparities of colorectal cancer in the United States as well.

AGA has been working for years to try to fix this issue, and supports the bipartisan Removing Barriers to Screening Act, which would correct this inequity for Medicare beneficiaries and remove the financial barriers that may prevent a patient from undergoing a screening. AGA is hopeful that the growing support for the legislation on both sides of the aisle will help get the bill passed this year. To learn more about this issue, visit http://www.gastro.org/take-action/top-issues/patient-cost-sharing-for-screening-colonoscopy. To help your patient understand this issue, AGA has created “What to Expect: Paying for Your Colonoscopy,” which can be downloaded at http://www.gastro.org/patient-care/procedures/Colonoscopy_CoPay_WhatToKnowFactSheet.pdf to be shared in your office. /p>

SOURCE: Peterse EFP et al. Health Affairs. 2017 Dec;36(12):2151-9.

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Experience may not always the best teacher

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“In medicine, a lack of experience may not actually be a bad thing.” The words leapt off my tablet, and my blood pressure hit the stratosphere. How could a 30-year-old physician who is still doing his cardiology fellowship have the nerve to take a cheap shot at one of the cornerstones of my identity? (“For Doctors, Age May Be More Than a Number,” by Haider Javed Warraich, The New York Times, Jan. 6, 2018.) My reputation as a skilled pediatrician was built on the breadth and depth of my clinical experience. In the first 30 years of my professional career, I had participated in more than 300,000 patient encounters. Wasn’t that effort good for something?

Darrin Klimek/Thinkstock
I stopped reading, set the tablet down, and went for a brisk walk around the neighborhood, hoping to get my emotions under control before reading on. Refreshed and tempered by the subzero air, I read on and discovered that Dr. Warraich had done his homework and offered some evidence to support his claim that, at least in medicine, experience may be overvalued.

He wrote that in a study of hospitalists (BMJ. 2017;357:j1797), the patient death rate increased steadily from 10.8% for physicians younger than 40 years to 12.1% for those 6o years and older, except those physicians treating a high volume of patients. He also cites a study in which the authors analyzed 62 studies of quality of care. The investigators found that slightly more than half of the studies “report decreasing performance with increasing years in practice” (Ann Int Med. 2005 Feb 15;142[4]:260-73).

Still in a defensive mode, I decided to chase down the references and take a closer look. In the study demonstrating patient mortality increasing with physician age, we must consider that these physicians were hospitalists and the patients were elderly. The observations may not be applicable to those seeing younger patients in a primary care office setting.

Another caveat listed by the authors is that the association between increasing patient mortality with increasing physician age did not hold true “among physicians with high volumes of patients.” As a high-volume practitioner myself, I found this comforting. It may be that there is some threshold effect in which a little experience is a negative but a ton of experience is a plus. Experience can teach efficiency. But, of course, efficiency doesn’t always equate with quality.

The study citing a decline in quality of care with physician age is a bit more troublesome. However, it may be that, rightly or wrongly, older physicians who have seen the tide go in and out enough times are more hesitant to accept and adhere to “evidence-based” quality measures that they see as ephemeral.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff
It was Dr. Warraich’s citation from the journal Cancer that I had the most difficult time rationalizing. This study found that younger physicians were more likely to discuss end of life issues with patients (Cancer. 2010 Feb 15;116[4]:998-1006). I suspect this is a valid observation as I have always struggled with discussing subjects such as sexuality and end of life issues with patients.

After what for me was an inflammatory opening, Dr. Warraich’s article closes with the observation that “mentorship is a two-way street.” Any physician who has worked with medical students and inquisitive house officers realizes that our surplus of experience always can stand to gain a little refreshing from those who have little of their own.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.”

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“In medicine, a lack of experience may not actually be a bad thing.” The words leapt off my tablet, and my blood pressure hit the stratosphere. How could a 30-year-old physician who is still doing his cardiology fellowship have the nerve to take a cheap shot at one of the cornerstones of my identity? (“For Doctors, Age May Be More Than a Number,” by Haider Javed Warraich, The New York Times, Jan. 6, 2018.) My reputation as a skilled pediatrician was built on the breadth and depth of my clinical experience. In the first 30 years of my professional career, I had participated in more than 300,000 patient encounters. Wasn’t that effort good for something?

Darrin Klimek/Thinkstock
I stopped reading, set the tablet down, and went for a brisk walk around the neighborhood, hoping to get my emotions under control before reading on. Refreshed and tempered by the subzero air, I read on and discovered that Dr. Warraich had done his homework and offered some evidence to support his claim that, at least in medicine, experience may be overvalued.

He wrote that in a study of hospitalists (BMJ. 2017;357:j1797), the patient death rate increased steadily from 10.8% for physicians younger than 40 years to 12.1% for those 6o years and older, except those physicians treating a high volume of patients. He also cites a study in which the authors analyzed 62 studies of quality of care. The investigators found that slightly more than half of the studies “report decreasing performance with increasing years in practice” (Ann Int Med. 2005 Feb 15;142[4]:260-73).

Still in a defensive mode, I decided to chase down the references and take a closer look. In the study demonstrating patient mortality increasing with physician age, we must consider that these physicians were hospitalists and the patients were elderly. The observations may not be applicable to those seeing younger patients in a primary care office setting.

Another caveat listed by the authors is that the association between increasing patient mortality with increasing physician age did not hold true “among physicians with high volumes of patients.” As a high-volume practitioner myself, I found this comforting. It may be that there is some threshold effect in which a little experience is a negative but a ton of experience is a plus. Experience can teach efficiency. But, of course, efficiency doesn’t always equate with quality.

The study citing a decline in quality of care with physician age is a bit more troublesome. However, it may be that, rightly or wrongly, older physicians who have seen the tide go in and out enough times are more hesitant to accept and adhere to “evidence-based” quality measures that they see as ephemeral.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff
It was Dr. Warraich’s citation from the journal Cancer that I had the most difficult time rationalizing. This study found that younger physicians were more likely to discuss end of life issues with patients (Cancer. 2010 Feb 15;116[4]:998-1006). I suspect this is a valid observation as I have always struggled with discussing subjects such as sexuality and end of life issues with patients.

After what for me was an inflammatory opening, Dr. Warraich’s article closes with the observation that “mentorship is a two-way street.” Any physician who has worked with medical students and inquisitive house officers realizes that our surplus of experience always can stand to gain a little refreshing from those who have little of their own.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.”

 

“In medicine, a lack of experience may not actually be a bad thing.” The words leapt off my tablet, and my blood pressure hit the stratosphere. How could a 30-year-old physician who is still doing his cardiology fellowship have the nerve to take a cheap shot at one of the cornerstones of my identity? (“For Doctors, Age May Be More Than a Number,” by Haider Javed Warraich, The New York Times, Jan. 6, 2018.) My reputation as a skilled pediatrician was built on the breadth and depth of my clinical experience. In the first 30 years of my professional career, I had participated in more than 300,000 patient encounters. Wasn’t that effort good for something?

Darrin Klimek/Thinkstock
I stopped reading, set the tablet down, and went for a brisk walk around the neighborhood, hoping to get my emotions under control before reading on. Refreshed and tempered by the subzero air, I read on and discovered that Dr. Warraich had done his homework and offered some evidence to support his claim that, at least in medicine, experience may be overvalued.

He wrote that in a study of hospitalists (BMJ. 2017;357:j1797), the patient death rate increased steadily from 10.8% for physicians younger than 40 years to 12.1% for those 6o years and older, except those physicians treating a high volume of patients. He also cites a study in which the authors analyzed 62 studies of quality of care. The investigators found that slightly more than half of the studies “report decreasing performance with increasing years in practice” (Ann Int Med. 2005 Feb 15;142[4]:260-73).

Still in a defensive mode, I decided to chase down the references and take a closer look. In the study demonstrating patient mortality increasing with physician age, we must consider that these physicians were hospitalists and the patients were elderly. The observations may not be applicable to those seeing younger patients in a primary care office setting.

Another caveat listed by the authors is that the association between increasing patient mortality with increasing physician age did not hold true “among physicians with high volumes of patients.” As a high-volume practitioner myself, I found this comforting. It may be that there is some threshold effect in which a little experience is a negative but a ton of experience is a plus. Experience can teach efficiency. But, of course, efficiency doesn’t always equate with quality.

The study citing a decline in quality of care with physician age is a bit more troublesome. However, it may be that, rightly or wrongly, older physicians who have seen the tide go in and out enough times are more hesitant to accept and adhere to “evidence-based” quality measures that they see as ephemeral.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff
It was Dr. Warraich’s citation from the journal Cancer that I had the most difficult time rationalizing. This study found that younger physicians were more likely to discuss end of life issues with patients (Cancer. 2010 Feb 15;116[4]:998-1006). I suspect this is a valid observation as I have always struggled with discussing subjects such as sexuality and end of life issues with patients.

After what for me was an inflammatory opening, Dr. Warraich’s article closes with the observation that “mentorship is a two-way street.” Any physician who has worked with medical students and inquisitive house officers realizes that our surplus of experience always can stand to gain a little refreshing from those who have little of their own.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.”

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VIDEO: Lean body mass linked to atrial fib etiology

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Tue, 07/21/2020 - 14:18

– Results from a large Danish epidemiologic study published in 2017 upended the traditional view that obesity directly contributes to new onset atrial fibrillation by instead fingering lean body mass as the key body-habitus culprit.

“It’s a very different way of thinking about obesity” and it’s relationship to the etiology of atrial fibrillation, Stanley Nattel, MD, said in a video interview at the annual International AF Symposium. “I wouldn’t qualify it yet as a complete shift,” because the results came from a single study, “but the results are quite persuasive and very interesting,” said Dr. Nattel, professor of medicine and director of the electrophysiology research program at the Montreal Heart Institute.

The study he cited tracked the incidence of atrial fibrillation during median of 17 years in more than 55,000 Danish people who were aged 50-64 years old at baseline, and showed that lean body mass was the predominant anthropometric risk factor for new-onset atrial fibrillation (J Am Coll Cardiol. 2017 May;69[20]:2488-97). When the article appeared, it was accompanied by an editorial written by Dr. Nattel (J Am Coll Cardiol. 2017 May;69[20]2498-501).

“People had not thought a lot in the past” about lean body mass and atrial fibrillation, he noted.

If the finding is confirmed, it might make sense to target screening for atrial fibrillation to people with higher levels of lean body mass, Dr. Nattel suggested.

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– Results from a large Danish epidemiologic study published in 2017 upended the traditional view that obesity directly contributes to new onset atrial fibrillation by instead fingering lean body mass as the key body-habitus culprit.

“It’s a very different way of thinking about obesity” and it’s relationship to the etiology of atrial fibrillation, Stanley Nattel, MD, said in a video interview at the annual International AF Symposium. “I wouldn’t qualify it yet as a complete shift,” because the results came from a single study, “but the results are quite persuasive and very interesting,” said Dr. Nattel, professor of medicine and director of the electrophysiology research program at the Montreal Heart Institute.

The study he cited tracked the incidence of atrial fibrillation during median of 17 years in more than 55,000 Danish people who were aged 50-64 years old at baseline, and showed that lean body mass was the predominant anthropometric risk factor for new-onset atrial fibrillation (J Am Coll Cardiol. 2017 May;69[20]:2488-97). When the article appeared, it was accompanied by an editorial written by Dr. Nattel (J Am Coll Cardiol. 2017 May;69[20]2498-501).

“People had not thought a lot in the past” about lean body mass and atrial fibrillation, he noted.

If the finding is confirmed, it might make sense to target screening for atrial fibrillation to people with higher levels of lean body mass, Dr. Nattel suggested.

– Results from a large Danish epidemiologic study published in 2017 upended the traditional view that obesity directly contributes to new onset atrial fibrillation by instead fingering lean body mass as the key body-habitus culprit.

“It’s a very different way of thinking about obesity” and it’s relationship to the etiology of atrial fibrillation, Stanley Nattel, MD, said in a video interview at the annual International AF Symposium. “I wouldn’t qualify it yet as a complete shift,” because the results came from a single study, “but the results are quite persuasive and very interesting,” said Dr. Nattel, professor of medicine and director of the electrophysiology research program at the Montreal Heart Institute.

The study he cited tracked the incidence of atrial fibrillation during median of 17 years in more than 55,000 Danish people who were aged 50-64 years old at baseline, and showed that lean body mass was the predominant anthropometric risk factor for new-onset atrial fibrillation (J Am Coll Cardiol. 2017 May;69[20]:2488-97). When the article appeared, it was accompanied by an editorial written by Dr. Nattel (J Am Coll Cardiol. 2017 May;69[20]2498-501).

“People had not thought a lot in the past” about lean body mass and atrial fibrillation, he noted.

If the finding is confirmed, it might make sense to target screening for atrial fibrillation to people with higher levels of lean body mass, Dr. Nattel suggested.

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Age at RRSO affects peritoneal cancer risk in BRCA mutation carriers

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Carriers of the BRCA1/2 mutation who undergo risk-reducing salpingo-oophorectomy (RRSO) still face a risk of developing metachronous peritoneal carcinomatosis, according to new findings published in Cancer.

The risk was predominantly observed in BRCA1 mutation carriers, and disease development generally occurred within 5 years following RRSO. Women who underwent RRSO at an age older than that currently recommended also had a higher risk of developing peritoneal carcinoma.

Their median age was 52 years at the time they underwent surgery, and 60 years when they were diagnosed with peritoneal carcinomatosis. As compared with the control group, the patients were older at the time they underwent RRSO (P = .025).

In eight RRSO specimens that were obtained from women who subsequently developed peritoneal carcinomatosis, five (62.5%), had serous tubal intraepithelial carcinoma (STIC) and one had epithelial atypia.

“The findings of the current study can be used to refine gynecologic counseling for BRCA1/2 mutation carriers who consider risk-reducing surgery and to stress the importance of complete RRSO at the recommended ages,” wrote lead author Marline G. Harmsen, MD, PhD, of the Radboud University Medical Center, Nijmegen, the Netherlands.

BRCA1/2 mutation carriers face a higher risk of developing ovarian carcinoma, and RRSO can reduce that risk by 80%-96%. Surgery is recommended for carriers of BRCA1 mutations aged 35-40 years and for BRCA2 mutation carriers aged 40-45 years.

In this study, Dr. Harmsen and her colleagues conducted a literature search in order to collect and analyze clinical and pathological data from women with BRCA1/2 mutation who developed peritoneal carcinomatosis following RRSO. The cases that were identified were then compared with a cohort from a single institution.

Of the 36 cases that were identified, 86.1% were BRCA1 mutation carriers and the remaining 5 patients had a BRCA2 mutation. The median age at the time of surgery differed significantly between BRCA1 (51 years; range, 30-71 years) and BRCA2 mutation carriers (57 years; range, 56-65 years) (P = .006).

The majority of women had undergone salpingo-oophorectomy (31; 86.1%), and 16 (44.4%) had also had a hysterectomy.

The authors found that several statistically significant differences between the case studies and the control group: the median age surgery (52 vs. 46 years), percentage of BRCA1 mutation carriers (86.1% vs. 53.1%, P less than .001), and percentage of serous tubal intraepithelial carcinomas in the RRSO specimens (62.5% vs. 0%; P less than .001).

SOURCE: Hamsen MG et al. Cancer. 2018 Jan 9. doi: 10.1002/cncr.31211.

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In an accompanying editorial, Christine S. Walsh, MD, of Cedars-Sinai Medical Center in Los Angeles, notes that the study authors have “done a commendable job in trying to shed light on a rare condition,” which occurs in about 1%-4% of women who undergo risk-reducing salpingo-oophorectomy (RRSO).

These findings can provide more information to clinicians, as they seek to guide and counsel women after they undergo RRSO, she wrote.

Dr. Walsh pointed out that National Comprehensive Cancer Network guidelines for genetic/familial high-risk assessment of breast and ovarian cancer specify the optimal ages when RRSO should be performed, but despite efforts to encourage this, occult gynecologic carcinomas still are found in approximately 4.5%-9% of women, with serous tubal intraepithelial carcinoma lesions developing in approximately 5%-8% of them.

“Ideally, the goal should be to intervene with a prophylactic surgery before the development of cancerous or precancerous pathology,” she wrote. Dr. Walsh had no disclosures.

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In an accompanying editorial, Christine S. Walsh, MD, of Cedars-Sinai Medical Center in Los Angeles, notes that the study authors have “done a commendable job in trying to shed light on a rare condition,” which occurs in about 1%-4% of women who undergo risk-reducing salpingo-oophorectomy (RRSO).

These findings can provide more information to clinicians, as they seek to guide and counsel women after they undergo RRSO, she wrote.

Dr. Walsh pointed out that National Comprehensive Cancer Network guidelines for genetic/familial high-risk assessment of breast and ovarian cancer specify the optimal ages when RRSO should be performed, but despite efforts to encourage this, occult gynecologic carcinomas still are found in approximately 4.5%-9% of women, with serous tubal intraepithelial carcinoma lesions developing in approximately 5%-8% of them.

“Ideally, the goal should be to intervene with a prophylactic surgery before the development of cancerous or precancerous pathology,” she wrote. Dr. Walsh had no disclosures.

Body

 

In an accompanying editorial, Christine S. Walsh, MD, of Cedars-Sinai Medical Center in Los Angeles, notes that the study authors have “done a commendable job in trying to shed light on a rare condition,” which occurs in about 1%-4% of women who undergo risk-reducing salpingo-oophorectomy (RRSO).

These findings can provide more information to clinicians, as they seek to guide and counsel women after they undergo RRSO, she wrote.

Dr. Walsh pointed out that National Comprehensive Cancer Network guidelines for genetic/familial high-risk assessment of breast and ovarian cancer specify the optimal ages when RRSO should be performed, but despite efforts to encourage this, occult gynecologic carcinomas still are found in approximately 4.5%-9% of women, with serous tubal intraepithelial carcinoma lesions developing in approximately 5%-8% of them.

“Ideally, the goal should be to intervene with a prophylactic surgery before the development of cancerous or precancerous pathology,” she wrote. Dr. Walsh had no disclosures.

 

Carriers of the BRCA1/2 mutation who undergo risk-reducing salpingo-oophorectomy (RRSO) still face a risk of developing metachronous peritoneal carcinomatosis, according to new findings published in Cancer.

The risk was predominantly observed in BRCA1 mutation carriers, and disease development generally occurred within 5 years following RRSO. Women who underwent RRSO at an age older than that currently recommended also had a higher risk of developing peritoneal carcinoma.

Their median age was 52 years at the time they underwent surgery, and 60 years when they were diagnosed with peritoneal carcinomatosis. As compared with the control group, the patients were older at the time they underwent RRSO (P = .025).

In eight RRSO specimens that were obtained from women who subsequently developed peritoneal carcinomatosis, five (62.5%), had serous tubal intraepithelial carcinoma (STIC) and one had epithelial atypia.

“The findings of the current study can be used to refine gynecologic counseling for BRCA1/2 mutation carriers who consider risk-reducing surgery and to stress the importance of complete RRSO at the recommended ages,” wrote lead author Marline G. Harmsen, MD, PhD, of the Radboud University Medical Center, Nijmegen, the Netherlands.

BRCA1/2 mutation carriers face a higher risk of developing ovarian carcinoma, and RRSO can reduce that risk by 80%-96%. Surgery is recommended for carriers of BRCA1 mutations aged 35-40 years and for BRCA2 mutation carriers aged 40-45 years.

In this study, Dr. Harmsen and her colleagues conducted a literature search in order to collect and analyze clinical and pathological data from women with BRCA1/2 mutation who developed peritoneal carcinomatosis following RRSO. The cases that were identified were then compared with a cohort from a single institution.

Of the 36 cases that were identified, 86.1% were BRCA1 mutation carriers and the remaining 5 patients had a BRCA2 mutation. The median age at the time of surgery differed significantly between BRCA1 (51 years; range, 30-71 years) and BRCA2 mutation carriers (57 years; range, 56-65 years) (P = .006).

The majority of women had undergone salpingo-oophorectomy (31; 86.1%), and 16 (44.4%) had also had a hysterectomy.

The authors found that several statistically significant differences between the case studies and the control group: the median age surgery (52 vs. 46 years), percentage of BRCA1 mutation carriers (86.1% vs. 53.1%, P less than .001), and percentage of serous tubal intraepithelial carcinomas in the RRSO specimens (62.5% vs. 0%; P less than .001).

SOURCE: Hamsen MG et al. Cancer. 2018 Jan 9. doi: 10.1002/cncr.31211.

 

Carriers of the BRCA1/2 mutation who undergo risk-reducing salpingo-oophorectomy (RRSO) still face a risk of developing metachronous peritoneal carcinomatosis, according to new findings published in Cancer.

The risk was predominantly observed in BRCA1 mutation carriers, and disease development generally occurred within 5 years following RRSO. Women who underwent RRSO at an age older than that currently recommended also had a higher risk of developing peritoneal carcinoma.

Their median age was 52 years at the time they underwent surgery, and 60 years when they were diagnosed with peritoneal carcinomatosis. As compared with the control group, the patients were older at the time they underwent RRSO (P = .025).

In eight RRSO specimens that were obtained from women who subsequently developed peritoneal carcinomatosis, five (62.5%), had serous tubal intraepithelial carcinoma (STIC) and one had epithelial atypia.

“The findings of the current study can be used to refine gynecologic counseling for BRCA1/2 mutation carriers who consider risk-reducing surgery and to stress the importance of complete RRSO at the recommended ages,” wrote lead author Marline G. Harmsen, MD, PhD, of the Radboud University Medical Center, Nijmegen, the Netherlands.

BRCA1/2 mutation carriers face a higher risk of developing ovarian carcinoma, and RRSO can reduce that risk by 80%-96%. Surgery is recommended for carriers of BRCA1 mutations aged 35-40 years and for BRCA2 mutation carriers aged 40-45 years.

In this study, Dr. Harmsen and her colleagues conducted a literature search in order to collect and analyze clinical and pathological data from women with BRCA1/2 mutation who developed peritoneal carcinomatosis following RRSO. The cases that were identified were then compared with a cohort from a single institution.

Of the 36 cases that were identified, 86.1% were BRCA1 mutation carriers and the remaining 5 patients had a BRCA2 mutation. The median age at the time of surgery differed significantly between BRCA1 (51 years; range, 30-71 years) and BRCA2 mutation carriers (57 years; range, 56-65 years) (P = .006).

The majority of women had undergone salpingo-oophorectomy (31; 86.1%), and 16 (44.4%) had also had a hysterectomy.

The authors found that several statistically significant differences between the case studies and the control group: the median age surgery (52 vs. 46 years), percentage of BRCA1 mutation carriers (86.1% vs. 53.1%, P less than .001), and percentage of serous tubal intraepithelial carcinomas in the RRSO specimens (62.5% vs. 0%; P less than .001).

SOURCE: Hamsen MG et al. Cancer. 2018 Jan 9. doi: 10.1002/cncr.31211.

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Key clinical point: BRCA mutation carriers who undergo risk-reducing surgery at an older age have a higher risk of developing metachronous peritoneal carcinomatosis.

Major finding: Women with BRCA 1 were at a higher risk for developing peritoneal carcinomatosis, as were those who underwent surgery at an older age.

Data source: A literature search to identify patients with BRCA 1/2 mutations who had undergone risk-reducing surgery and developed peritoneal carcinomatosis; 36 cases were identified and compared with a control group from a single institution.

Disclosures: No specific funding was disclosed. The authors had no disclosures.

Source: Hamsen MG et al. Cancer. 2018 Jan 9. doi: 10.1002/cncr.31211.

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FDA approves PARP inhibitor for BRCA+ advanced breast cancer

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Thu, 12/15/2022 - 17:49

 

The Food and Drug Administration has approved the PARP inhibitor olaparib for the treatment of patients with germline BRCA-positive, HER2-negative metastatic breast cancer who have previously received chemotherapy.

This is the first PARP inhibitor approved to treat breast cancer and the first approval for treatment of patients with metastatic breast cancer who have a BRCA gene mutation, the FDA said in a press statement.

The FDA also expanded approval of the companion diagnostic, BRACAnalysis CDx, to include the detection of BRCA mutations in blood samples from patients with breast cancer.


A capsule form of olaparib (Lynparza) was first approved in 2014 for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. In August 2017, the FDA granted regular approval to olaparib tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. Olaparib tablets and capsules are not interchangeable. Olaparib capsules are being phased out of the U.S. market and will be available only through the Lynparza Specialty Pharmacy Network, the FDA said.

Approval for the treatment of breast cancer was based on a 2.8 month improvement in progression-free survival with olaparib vs standard chemotherapy in the phase 3 OlympiAD trial of 302 previously treated patients with BRCA-positive, HER2-negative breast cancer. Results of the trial were presented at ASCO 2017 and simultaneously published in the New England Journal of Medicine (N Engl J Med. 2017 Jun 4. doi: 10.1056/NEJMoa1706450).

Common side effects of olaparib include anemia, neutropenia, leukopenia, nausea, fatigue, vomiting, nasopharyngitis, respiratory tract infection, influenza, diarrhea, arthralgia/myalgia, dysgeusia, headache, dyspepsia, decreased appetite, constipation and stomatitis.

Severe side effects include development of myelodysplastic syndrome/acute myeloid leukemia and pneumonitis. Women should be advised of the potential risk to the fetus and to use effective contraception, the FDA said.

The FDA granted the approval of olaparib to AstraZeneca Pharmaceuticals LP and the approval of the BRACAnalysis CDx to Myriad Genetic Laboratories, Inc.

 

 

 

 

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The Food and Drug Administration has approved the PARP inhibitor olaparib for the treatment of patients with germline BRCA-positive, HER2-negative metastatic breast cancer who have previously received chemotherapy.

This is the first PARP inhibitor approved to treat breast cancer and the first approval for treatment of patients with metastatic breast cancer who have a BRCA gene mutation, the FDA said in a press statement.

The FDA also expanded approval of the companion diagnostic, BRACAnalysis CDx, to include the detection of BRCA mutations in blood samples from patients with breast cancer.


A capsule form of olaparib (Lynparza) was first approved in 2014 for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. In August 2017, the FDA granted regular approval to olaparib tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. Olaparib tablets and capsules are not interchangeable. Olaparib capsules are being phased out of the U.S. market and will be available only through the Lynparza Specialty Pharmacy Network, the FDA said.

Approval for the treatment of breast cancer was based on a 2.8 month improvement in progression-free survival with olaparib vs standard chemotherapy in the phase 3 OlympiAD trial of 302 previously treated patients with BRCA-positive, HER2-negative breast cancer. Results of the trial were presented at ASCO 2017 and simultaneously published in the New England Journal of Medicine (N Engl J Med. 2017 Jun 4. doi: 10.1056/NEJMoa1706450).

Common side effects of olaparib include anemia, neutropenia, leukopenia, nausea, fatigue, vomiting, nasopharyngitis, respiratory tract infection, influenza, diarrhea, arthralgia/myalgia, dysgeusia, headache, dyspepsia, decreased appetite, constipation and stomatitis.

Severe side effects include development of myelodysplastic syndrome/acute myeloid leukemia and pneumonitis. Women should be advised of the potential risk to the fetus and to use effective contraception, the FDA said.

The FDA granted the approval of olaparib to AstraZeneca Pharmaceuticals LP and the approval of the BRACAnalysis CDx to Myriad Genetic Laboratories, Inc.

 

 

 

 

 

The Food and Drug Administration has approved the PARP inhibitor olaparib for the treatment of patients with germline BRCA-positive, HER2-negative metastatic breast cancer who have previously received chemotherapy.

This is the first PARP inhibitor approved to treat breast cancer and the first approval for treatment of patients with metastatic breast cancer who have a BRCA gene mutation, the FDA said in a press statement.

The FDA also expanded approval of the companion diagnostic, BRACAnalysis CDx, to include the detection of BRCA mutations in blood samples from patients with breast cancer.


A capsule form of olaparib (Lynparza) was first approved in 2014 for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. In August 2017, the FDA granted regular approval to olaparib tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. Olaparib tablets and capsules are not interchangeable. Olaparib capsules are being phased out of the U.S. market and will be available only through the Lynparza Specialty Pharmacy Network, the FDA said.

Approval for the treatment of breast cancer was based on a 2.8 month improvement in progression-free survival with olaparib vs standard chemotherapy in the phase 3 OlympiAD trial of 302 previously treated patients with BRCA-positive, HER2-negative breast cancer. Results of the trial were presented at ASCO 2017 and simultaneously published in the New England Journal of Medicine (N Engl J Med. 2017 Jun 4. doi: 10.1056/NEJMoa1706450).

Common side effects of olaparib include anemia, neutropenia, leukopenia, nausea, fatigue, vomiting, nasopharyngitis, respiratory tract infection, influenza, diarrhea, arthralgia/myalgia, dysgeusia, headache, dyspepsia, decreased appetite, constipation and stomatitis.

Severe side effects include development of myelodysplastic syndrome/acute myeloid leukemia and pneumonitis. Women should be advised of the potential risk to the fetus and to use effective contraception, the FDA said.

The FDA granted the approval of olaparib to AstraZeneca Pharmaceuticals LP and the approval of the BRACAnalysis CDx to Myriad Genetic Laboratories, Inc.

 

 

 

 

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Prescribe antibiotics wisely

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Fri, 09/14/2018 - 11:55

 

Clinical question: What is the incidence of antibiotic-associated adverse drug events (ADEs) among adult inpatients?

Background: Antibiotics are used widely in the inpatient setting, although 20%-30% of inpatient antibiotic prescription are estimated to be unnecessary. Data are lacking on the rates of associated ADEs.

Study design: Retrospective cohort study.

Setting: A single 1,194-bed academic tertiary medical center.

Synopsis: Of the 5,579 patients admitted to four inpatient medicine services between September 2013 and June 2014, 1,488 (27%) received antibiotics for at least 24 hours. Patients were followed through admission and out to 90 days. A total of 324 unique antibiotic-associated ADEs occurred among 298 (20%) patients within 90 days of initial therapy. The overall rate of antibiotic-associated ADEs was 22.9/10,000 person-days. The investigators determined that 287 (19%) of antibiotic regimens were not clinically indicated, and among those, there were 56 (20%) ADEs. The most common 30-day ADEs were gastrointestinal, renal, and hematologic. The highest proportion of ADEs occurred with beta-lactams, fluoroquinolones, intravenous vancomycin, and trimethoprim-sulfamethoxazole, perhaps reflecting how commonly these agents are prescribed. Nearly all ADEs were considered clinically significant (97%). There were no deaths attributable to antibiotic-associated ADEs.

Bottom line: Antibiotic associated ADEs occur in about one in five inpatients, and about one in five antibiotic prescriptions may not be clinically indicated.

Citation: Tamma PD et al. Association of adverse events with antibiotic use in hospitalized patients. JAMA Intern Med. 2017 Sep 1;177(9):1308-15.

Dr. Anderson is an associate program director in the internal medicine residency training program at the University of Colorado School of Medicine and a hospitalist at the VA Eastern Colorado Health Care System in Denver.

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Clinical question: What is the incidence of antibiotic-associated adverse drug events (ADEs) among adult inpatients?

Background: Antibiotics are used widely in the inpatient setting, although 20%-30% of inpatient antibiotic prescription are estimated to be unnecessary. Data are lacking on the rates of associated ADEs.

Study design: Retrospective cohort study.

Setting: A single 1,194-bed academic tertiary medical center.

Synopsis: Of the 5,579 patients admitted to four inpatient medicine services between September 2013 and June 2014, 1,488 (27%) received antibiotics for at least 24 hours. Patients were followed through admission and out to 90 days. A total of 324 unique antibiotic-associated ADEs occurred among 298 (20%) patients within 90 days of initial therapy. The overall rate of antibiotic-associated ADEs was 22.9/10,000 person-days. The investigators determined that 287 (19%) of antibiotic regimens were not clinically indicated, and among those, there were 56 (20%) ADEs. The most common 30-day ADEs were gastrointestinal, renal, and hematologic. The highest proportion of ADEs occurred with beta-lactams, fluoroquinolones, intravenous vancomycin, and trimethoprim-sulfamethoxazole, perhaps reflecting how commonly these agents are prescribed. Nearly all ADEs were considered clinically significant (97%). There were no deaths attributable to antibiotic-associated ADEs.

Bottom line: Antibiotic associated ADEs occur in about one in five inpatients, and about one in five antibiotic prescriptions may not be clinically indicated.

Citation: Tamma PD et al. Association of adverse events with antibiotic use in hospitalized patients. JAMA Intern Med. 2017 Sep 1;177(9):1308-15.

Dr. Anderson is an associate program director in the internal medicine residency training program at the University of Colorado School of Medicine and a hospitalist at the VA Eastern Colorado Health Care System in Denver.

 

Clinical question: What is the incidence of antibiotic-associated adverse drug events (ADEs) among adult inpatients?

Background: Antibiotics are used widely in the inpatient setting, although 20%-30% of inpatient antibiotic prescription are estimated to be unnecessary. Data are lacking on the rates of associated ADEs.

Study design: Retrospective cohort study.

Setting: A single 1,194-bed academic tertiary medical center.

Synopsis: Of the 5,579 patients admitted to four inpatient medicine services between September 2013 and June 2014, 1,488 (27%) received antibiotics for at least 24 hours. Patients were followed through admission and out to 90 days. A total of 324 unique antibiotic-associated ADEs occurred among 298 (20%) patients within 90 days of initial therapy. The overall rate of antibiotic-associated ADEs was 22.9/10,000 person-days. The investigators determined that 287 (19%) of antibiotic regimens were not clinically indicated, and among those, there were 56 (20%) ADEs. The most common 30-day ADEs were gastrointestinal, renal, and hematologic. The highest proportion of ADEs occurred with beta-lactams, fluoroquinolones, intravenous vancomycin, and trimethoprim-sulfamethoxazole, perhaps reflecting how commonly these agents are prescribed. Nearly all ADEs were considered clinically significant (97%). There were no deaths attributable to antibiotic-associated ADEs.

Bottom line: Antibiotic associated ADEs occur in about one in five inpatients, and about one in five antibiotic prescriptions may not be clinically indicated.

Citation: Tamma PD et al. Association of adverse events with antibiotic use in hospitalized patients. JAMA Intern Med. 2017 Sep 1;177(9):1308-15.

Dr. Anderson is an associate program director in the internal medicine residency training program at the University of Colorado School of Medicine and a hospitalist at the VA Eastern Colorado Health Care System in Denver.

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Closing the Timing Gap Between HIV Infection and Diagnosis

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Tue, 08/21/2018 - 13:34
CDC finds certain demographics are living with undiagnosed HIV infection much longer than are others.

In 2015, nearly 40,000 people were diagnosed with HIV infection. Half of those had been living with HIV for at least 3 years. One-quarter had been infected for ≥ 7 years.

But now HIV is being diagnosed sooner than before after infection. The estimated median time from infection to diagnosis in 2015 was 3 years compared with 3 years and 7 months in 2011, according to a CDC Vital Signs report.

Estimated median time from infection to diagnosis ranged from 5 years for heterosexual men to 2 and one-half for heterosexual women and women who inject drugs. The median time was 4 years for Asian Americans, 3 years for African Americans and Latinos, and 2 years for whites.

The percentage of people at high risk for HIV who report getting a test the previous year also has risen. Despite that progress, though, the CDC says “too few are tested.”

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CDC finds certain demographics are living with undiagnosed HIV infection much longer than are others.
CDC finds certain demographics are living with undiagnosed HIV infection much longer than are others.

In 2015, nearly 40,000 people were diagnosed with HIV infection. Half of those had been living with HIV for at least 3 years. One-quarter had been infected for ≥ 7 years.

But now HIV is being diagnosed sooner than before after infection. The estimated median time from infection to diagnosis in 2015 was 3 years compared with 3 years and 7 months in 2011, according to a CDC Vital Signs report.

Estimated median time from infection to diagnosis ranged from 5 years for heterosexual men to 2 and one-half for heterosexual women and women who inject drugs. The median time was 4 years for Asian Americans, 3 years for African Americans and Latinos, and 2 years for whites.

The percentage of people at high risk for HIV who report getting a test the previous year also has risen. Despite that progress, though, the CDC says “too few are tested.”

In 2015, nearly 40,000 people were diagnosed with HIV infection. Half of those had been living with HIV for at least 3 years. One-quarter had been infected for ≥ 7 years.

But now HIV is being diagnosed sooner than before after infection. The estimated median time from infection to diagnosis in 2015 was 3 years compared with 3 years and 7 months in 2011, according to a CDC Vital Signs report.

Estimated median time from infection to diagnosis ranged from 5 years for heterosexual men to 2 and one-half for heterosexual women and women who inject drugs. The median time was 4 years for Asian Americans, 3 years for African Americans and Latinos, and 2 years for whites.

The percentage of people at high risk for HIV who report getting a test the previous year also has risen. Despite that progress, though, the CDC says “too few are tested.”

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Clinical Trial Begins for Long-Acting Anti-HIV Injectable

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Tue, 08/21/2018 - 13:36
New NIH-sponsored clinical trial compares the efficacy and safety of an injectable with the orally distributed HIV contraception.

A clinical trial to test a new, potentially more convenient HIV prophylaxis for women is starting in Africa. It is a long-acting form of the investigational drug cabotegravir and could give sexually active women a choice of biomedical HIV prevention tools for the first time, similar to the choices available for contraception, says Sinead Delany-Moretiwe, PhD, chair of the protocol.

The trial, HPTN 084, will enroll about 3,200 women aged 18 to 45 years at 20 sites in 7 countries. The women will be randomly assigned to either cabotegravir and a placebo pill or Truvada, which is a combination of emtricitabine and tenofovir disoproxil fumarate. Truvada, currently the only drug licensed for HIV pre-exposure prophylaxis, must be taken every day to achieve and maintain protective drug concentrations. The women will start with 2 cabotegravir injections 4 weeks apart, then receive injections once every 8 weeks for an average of 2.6 years. After completing the injections, participants will be offered 48 weeks of PrEP with daily oral Truvada.

The NIAID is sponsoring the phase 3 clinical trial and cofunding it in a unique partnership with ViiV Healthcare (which is providing the study medications with Gilead Sciences) and the Bill & Melinda Gates Foundation.

Participants will receive HIV prevention counseling, condoms and lubricant, and counseling to support adherence to the daily pill. Anyone who becomes HIV infected during the trial will stop receiving the study products and be referred to local medical providers for care and treatment.

The study also will evaluate how women experience long-acting injectable cabotegravir, the researchers say. They are hoping to get a better understanding of the types of safe and effective HIV prevention that also fit best in women’s lives.

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New NIH-sponsored clinical trial compares the efficacy and safety of an injectable with the orally distributed HIV contraception.
New NIH-sponsored clinical trial compares the efficacy and safety of an injectable with the orally distributed HIV contraception.

A clinical trial to test a new, potentially more convenient HIV prophylaxis for women is starting in Africa. It is a long-acting form of the investigational drug cabotegravir and could give sexually active women a choice of biomedical HIV prevention tools for the first time, similar to the choices available for contraception, says Sinead Delany-Moretiwe, PhD, chair of the protocol.

The trial, HPTN 084, will enroll about 3,200 women aged 18 to 45 years at 20 sites in 7 countries. The women will be randomly assigned to either cabotegravir and a placebo pill or Truvada, which is a combination of emtricitabine and tenofovir disoproxil fumarate. Truvada, currently the only drug licensed for HIV pre-exposure prophylaxis, must be taken every day to achieve and maintain protective drug concentrations. The women will start with 2 cabotegravir injections 4 weeks apart, then receive injections once every 8 weeks for an average of 2.6 years. After completing the injections, participants will be offered 48 weeks of PrEP with daily oral Truvada.

The NIAID is sponsoring the phase 3 clinical trial and cofunding it in a unique partnership with ViiV Healthcare (which is providing the study medications with Gilead Sciences) and the Bill & Melinda Gates Foundation.

Participants will receive HIV prevention counseling, condoms and lubricant, and counseling to support adherence to the daily pill. Anyone who becomes HIV infected during the trial will stop receiving the study products and be referred to local medical providers for care and treatment.

The study also will evaluate how women experience long-acting injectable cabotegravir, the researchers say. They are hoping to get a better understanding of the types of safe and effective HIV prevention that also fit best in women’s lives.

A clinical trial to test a new, potentially more convenient HIV prophylaxis for women is starting in Africa. It is a long-acting form of the investigational drug cabotegravir and could give sexually active women a choice of biomedical HIV prevention tools for the first time, similar to the choices available for contraception, says Sinead Delany-Moretiwe, PhD, chair of the protocol.

The trial, HPTN 084, will enroll about 3,200 women aged 18 to 45 years at 20 sites in 7 countries. The women will be randomly assigned to either cabotegravir and a placebo pill or Truvada, which is a combination of emtricitabine and tenofovir disoproxil fumarate. Truvada, currently the only drug licensed for HIV pre-exposure prophylaxis, must be taken every day to achieve and maintain protective drug concentrations. The women will start with 2 cabotegravir injections 4 weeks apart, then receive injections once every 8 weeks for an average of 2.6 years. After completing the injections, participants will be offered 48 weeks of PrEP with daily oral Truvada.

The NIAID is sponsoring the phase 3 clinical trial and cofunding it in a unique partnership with ViiV Healthcare (which is providing the study medications with Gilead Sciences) and the Bill & Melinda Gates Foundation.

Participants will receive HIV prevention counseling, condoms and lubricant, and counseling to support adherence to the daily pill. Anyone who becomes HIV infected during the trial will stop receiving the study products and be referred to local medical providers for care and treatment.

The study also will evaluate how women experience long-acting injectable cabotegravir, the researchers say. They are hoping to get a better understanding of the types of safe and effective HIV prevention that also fit best in women’s lives.

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Interventions can increase cord blood donations

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Interventions can increase cord blood donations

Cord blood donation

Simple interventions can increase cord blood donations, according to research published in Scientific Reports.

Researchers saw a significant increase in cord blood donation when expectant mothers received information about the procedure and were asked to indicate their interest in donating at both early and late stages of their pregnancies.

“We more than doubled the number of cord blood units that were collected,” said study author Nicola Lacetera, PhD, of the University of Toronto Mississauga in Ontario, Canada.

“We learned a lot, and we did a little bit of good too, so that feels nice.”

Dr Lacetera and his colleagues conducted this study in Milan, Italy, where private cord blood banking is banned.

The team set out to determine if providing expectant mothers with information about cord blood donation and prompting them to consider the procedure would increase donations to a public cord blood bank.

Interventions

The researchers enrolled 850 expectant mothers and divided them into 6 treatment cohorts.

The T0 cohort included 217 control subjects who did not receive any information on cord blood donation.

The T1 cohort included 64 subjects who received information on cord blood donation during their first trimester.

The T2 cohort included 88 subjects who were given information on cord blood donation and asked about their intentions to donate in their first trimester.

The T3 cohort included 197 subjects who received information on cord blood donation in their third trimester.

The T4 cohort included 249 subjects who were given information on cord blood donation and asked about their intentions to donate during their third trimester.

The T5 cohort included 35 subjects who were given information on cord blood donation and asked about their intentions to donate during the first trimester and the third trimester.

Results

The researchers found that T5 subjects had the highest donation rate.

In the entire study sample, the donation rate was 2.3% (5/217) in controls, 6.3% (4/64) in T1 subjects, 1.1% (1/88) in T2, 8.1% (16/197) in T3, 10.0% (25/249) in T4, and 17.1% in T5 (6/35).

These results may not be entirely accurate, however, because the researchers could only confirm patients’ donation status if mothers delivered their babies at the study hospital, Ospedale dei Bambini Vittore Buzzi (also known as Buzzi Hospital, BH).

Among women who delivered at BH, donation rates were 2.7% (5/183) in controls, 11.7% (4/34) in T1, 2.2% (1/45) in T2, 8.9% (16/179) in T3, 11.4% (25/42) in T4, and 21.4% (6/28) in T5.

Though these data suggest the various interventions tested can increase cord blood donations, donation rates in this study could have been even higher, according to the researchers.

There were 197 women who submitted consent forms to donate cord blood, were medically eligible to donate, and delivered their babies at BH. However, only 57 of these women successfully donated cord blood.

There were 62 women (56.9%) who could not donate because of medical complications during delivery.

Thirty-three women (30.3%) failed to donate because of organizational reasons, including overcrowding of the delivery room and the absence of obstetric nurses certified to collect and process cord blood at the time of delivery.

There were 14 women (7.1%) who did not donate for institution-related reasons. For example, the women gave birth when the Milan Cord Blood Bank was closed.

There were no details on the remaining 31 women who failed to donate.

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Cord blood donation

Simple interventions can increase cord blood donations, according to research published in Scientific Reports.

Researchers saw a significant increase in cord blood donation when expectant mothers received information about the procedure and were asked to indicate their interest in donating at both early and late stages of their pregnancies.

“We more than doubled the number of cord blood units that were collected,” said study author Nicola Lacetera, PhD, of the University of Toronto Mississauga in Ontario, Canada.

“We learned a lot, and we did a little bit of good too, so that feels nice.”

Dr Lacetera and his colleagues conducted this study in Milan, Italy, where private cord blood banking is banned.

The team set out to determine if providing expectant mothers with information about cord blood donation and prompting them to consider the procedure would increase donations to a public cord blood bank.

Interventions

The researchers enrolled 850 expectant mothers and divided them into 6 treatment cohorts.

The T0 cohort included 217 control subjects who did not receive any information on cord blood donation.

The T1 cohort included 64 subjects who received information on cord blood donation during their first trimester.

The T2 cohort included 88 subjects who were given information on cord blood donation and asked about their intentions to donate in their first trimester.

The T3 cohort included 197 subjects who received information on cord blood donation in their third trimester.

The T4 cohort included 249 subjects who were given information on cord blood donation and asked about their intentions to donate during their third trimester.

The T5 cohort included 35 subjects who were given information on cord blood donation and asked about their intentions to donate during the first trimester and the third trimester.

Results

The researchers found that T5 subjects had the highest donation rate.

In the entire study sample, the donation rate was 2.3% (5/217) in controls, 6.3% (4/64) in T1 subjects, 1.1% (1/88) in T2, 8.1% (16/197) in T3, 10.0% (25/249) in T4, and 17.1% in T5 (6/35).

These results may not be entirely accurate, however, because the researchers could only confirm patients’ donation status if mothers delivered their babies at the study hospital, Ospedale dei Bambini Vittore Buzzi (also known as Buzzi Hospital, BH).

Among women who delivered at BH, donation rates were 2.7% (5/183) in controls, 11.7% (4/34) in T1, 2.2% (1/45) in T2, 8.9% (16/179) in T3, 11.4% (25/42) in T4, and 21.4% (6/28) in T5.

Though these data suggest the various interventions tested can increase cord blood donations, donation rates in this study could have been even higher, according to the researchers.

There were 197 women who submitted consent forms to donate cord blood, were medically eligible to donate, and delivered their babies at BH. However, only 57 of these women successfully donated cord blood.

There were 62 women (56.9%) who could not donate because of medical complications during delivery.

Thirty-three women (30.3%) failed to donate because of organizational reasons, including overcrowding of the delivery room and the absence of obstetric nurses certified to collect and process cord blood at the time of delivery.

There were 14 women (7.1%) who did not donate for institution-related reasons. For example, the women gave birth when the Milan Cord Blood Bank was closed.

There were no details on the remaining 31 women who failed to donate.

Cord blood donation

Simple interventions can increase cord blood donations, according to research published in Scientific Reports.

Researchers saw a significant increase in cord blood donation when expectant mothers received information about the procedure and were asked to indicate their interest in donating at both early and late stages of their pregnancies.

“We more than doubled the number of cord blood units that were collected,” said study author Nicola Lacetera, PhD, of the University of Toronto Mississauga in Ontario, Canada.

“We learned a lot, and we did a little bit of good too, so that feels nice.”

Dr Lacetera and his colleagues conducted this study in Milan, Italy, where private cord blood banking is banned.

The team set out to determine if providing expectant mothers with information about cord blood donation and prompting them to consider the procedure would increase donations to a public cord blood bank.

Interventions

The researchers enrolled 850 expectant mothers and divided them into 6 treatment cohorts.

The T0 cohort included 217 control subjects who did not receive any information on cord blood donation.

The T1 cohort included 64 subjects who received information on cord blood donation during their first trimester.

The T2 cohort included 88 subjects who were given information on cord blood donation and asked about their intentions to donate in their first trimester.

The T3 cohort included 197 subjects who received information on cord blood donation in their third trimester.

The T4 cohort included 249 subjects who were given information on cord blood donation and asked about their intentions to donate during their third trimester.

The T5 cohort included 35 subjects who were given information on cord blood donation and asked about their intentions to donate during the first trimester and the third trimester.

Results

The researchers found that T5 subjects had the highest donation rate.

In the entire study sample, the donation rate was 2.3% (5/217) in controls, 6.3% (4/64) in T1 subjects, 1.1% (1/88) in T2, 8.1% (16/197) in T3, 10.0% (25/249) in T4, and 17.1% in T5 (6/35).

These results may not be entirely accurate, however, because the researchers could only confirm patients’ donation status if mothers delivered their babies at the study hospital, Ospedale dei Bambini Vittore Buzzi (also known as Buzzi Hospital, BH).

Among women who delivered at BH, donation rates were 2.7% (5/183) in controls, 11.7% (4/34) in T1, 2.2% (1/45) in T2, 8.9% (16/179) in T3, 11.4% (25/42) in T4, and 21.4% (6/28) in T5.

Though these data suggest the various interventions tested can increase cord blood donations, donation rates in this study could have been even higher, according to the researchers.

There were 197 women who submitted consent forms to donate cord blood, were medically eligible to donate, and delivered their babies at BH. However, only 57 of these women successfully donated cord blood.

There were 62 women (56.9%) who could not donate because of medical complications during delivery.

Thirty-three women (30.3%) failed to donate because of organizational reasons, including overcrowding of the delivery room and the absence of obstetric nurses certified to collect and process cord blood at the time of delivery.

There were 14 women (7.1%) who did not donate for institution-related reasons. For example, the women gave birth when the Milan Cord Blood Bank was closed.

There were no details on the remaining 31 women who failed to donate.

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