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Drug price transparency laws gain ground
Connecticut is the latest state to enact a so-called drug price transparency law that imposes reporting requirements on drug makers, health insurers, and pharmacy benefit managers (PBMs).
The new requirements, signed into law by Connecticut Governor Dannel Malloy (D) on May 31, call on drug manufacturers to provide information about significant drug cost increases, including the factors that triggered the price hike and information about the drug’s development costs and capital expenditures. As part of the law, PBMs must report the volume of formulary rebates received from drug makers, including the portion provided to health insurers.
Connecticut’s law is the first to require that health insurers submit data about the most frequently prescribed and highest-cost drugs, as well as information about the impact of drug costs on the plan and its members.
Connecticut Comptroller Kevin Lembo called the law “groundbreaking” and said enactment of the measure is a victory for patients who pay outrageous prices while corporations are “enriched by big discounts.
“The extreme wealth exchange between corporate giants from pharmaceutical manufacturers to pharmacy benefit managers to insurance companies, will no longer happen in the dark,” Mr. Lembo said in a statement. “This legislative victory is a groundbreaking step, but the fight for fairness has only just begun as we continue the fight for relief at the pharmacy counter.”
Priscilla VanderVeer, a spokeswoman for Pharmaceutical Research and Manufacturers of America (PhRMA), said Connecticut’s law has some positive features, but does not go far enough in ensuring savings are passed along to patients.
“While we are glad that this legislation will require middlemen to report what portion of rebates are being passed on to consumers, we are disappointed that the final version of the legislation does not include provisions that would ensure steep rebates given to middlemen are passed on to consumers,” Ms. VanderVeer said in an interview. “Making sure that patients who share the cost of their prescription medicines also share the savings is one of the most important things we can do to provide relief for patients facing higher out-of-pocket costs at the pharmacy counter. We are committed to working with Connecticut lawmakers and other health care stakeholders to craft a solution that will provide patients with the solutions that matter the most to them.”_web.jpg)
At least seven other states have passed similar laws that aim to expose questionable medication pricing and compel drug makers to provide the reasoning behind their cost decisions. Between 2016 and 2018, drug price transparency laws were enacted in California, Louisiana, Nevada, New York, Oregon, Maryland, and Vermont. Maine meanwhile, has enacted legislation that requires the development of a plan to collect data from manufacturers.
The majority of drug price transparency laws require drug makers to report and justify dramatic drug price increases to the state. Maryland however, went a step further by allowing the state attorney general to take legal action against drug makers that price gouge and to obtain restitution for state health programs and patients. In April, a federal appeals court struck down Maryland’s law as unconstitutional, ruling that the measure violates the federal commerce clause because it attempts to regulate price transactions. The law remains in limbo while the legal challenge continues.
The recent drug price transparency laws are necessary first steps to enable states to better understand and anticipate price increases, said Jennifer Reck, project director for the National Academy for State Health Policy.
“Faced with unsustainable prescription drug price increases, states are passing laws to create greater transparency and accountability around pricing,” Ms. Reck said in an interview. 
However, with the exception of Maryland’s measure, the laws are limited because they do not empower states to take action when companies dramatically increase drug prices, she said. It’s also unclear what impact the greater transparency requirements will have on the marketplace, she added.
Gerard F. Anderson, PhD, a health policy and management professor at Johns Hopkins University in Baltimore, agreed that the drug price transparency laws are a good start. But a second component is needed so that states can take effective action, he said in an interview.
“Price transparency, alone, doesn’t do anything,” he said. “What you need to do is couple price transparency with some kind of other activity that would allow you to actually lower the price.”
Some of those other activities include prohibiting rebates by PBMs, rate setting, or establishing a maximum amount that patients should pay for certain drugs, he suggested.
Some states are already exploring policies that go beyond transparency to allow states to take action against overpricing of medications, Ms. Reck noted. New Jersey and Minnesota, for example, have introduced rate-setting bills that would create cost commissions with the authority to establish payment rates for drugs determined to be unjustifiably priced.
To truly lower drug costs for patients, state laws must be comprehensive and address the various rungs of the pharmaceutical supply chain, Ms. VanderVeer said. PhRMA supported Louisiana’s recent drug price transparency law, but has opposed laws in Vermont, California, and Nevada.
“If it is transparency legislation and other policies that actually help patients afford their medicines and make sure that they are getting access to the same discounts and rebates their insurers and PMBs are getting, then yes, we support it,” Ms. VanderVeer said in an interview. “Unfortunately, a lot of the so-called ‘transparency’ bills that have passed over the last few years do no such thing. All they do is look at one part of the supply chain – the inventors and manufacturers of the medicines – and completely leave out those in the middle and have no provisions in them that will help patients access or afford their medicines.”
Connecticut’s law goes into effect in January 2020.
Connecticut is the latest state to enact a so-called drug price transparency law that imposes reporting requirements on drug makers, health insurers, and pharmacy benefit managers (PBMs).
The new requirements, signed into law by Connecticut Governor Dannel Malloy (D) on May 31, call on drug manufacturers to provide information about significant drug cost increases, including the factors that triggered the price hike and information about the drug’s development costs and capital expenditures. As part of the law, PBMs must report the volume of formulary rebates received from drug makers, including the portion provided to health insurers.
Connecticut’s law is the first to require that health insurers submit data about the most frequently prescribed and highest-cost drugs, as well as information about the impact of drug costs on the plan and its members.
Connecticut Comptroller Kevin Lembo called the law “groundbreaking” and said enactment of the measure is a victory for patients who pay outrageous prices while corporations are “enriched by big discounts.
“The extreme wealth exchange between corporate giants from pharmaceutical manufacturers to pharmacy benefit managers to insurance companies, will no longer happen in the dark,” Mr. Lembo said in a statement. “This legislative victory is a groundbreaking step, but the fight for fairness has only just begun as we continue the fight for relief at the pharmacy counter.”
Priscilla VanderVeer, a spokeswoman for Pharmaceutical Research and Manufacturers of America (PhRMA), said Connecticut’s law has some positive features, but does not go far enough in ensuring savings are passed along to patients.
“While we are glad that this legislation will require middlemen to report what portion of rebates are being passed on to consumers, we are disappointed that the final version of the legislation does not include provisions that would ensure steep rebates given to middlemen are passed on to consumers,” Ms. VanderVeer said in an interview. “Making sure that patients who share the cost of their prescription medicines also share the savings is one of the most important things we can do to provide relief for patients facing higher out-of-pocket costs at the pharmacy counter. We are committed to working with Connecticut lawmakers and other health care stakeholders to craft a solution that will provide patients with the solutions that matter the most to them.”
At least seven other states have passed similar laws that aim to expose questionable medication pricing and compel drug makers to provide the reasoning behind their cost decisions. Between 2016 and 2018, drug price transparency laws were enacted in California, Louisiana, Nevada, New York, Oregon, Maryland, and Vermont. Maine meanwhile, has enacted legislation that requires the development of a plan to collect data from manufacturers.
The majority of drug price transparency laws require drug makers to report and justify dramatic drug price increases to the state. Maryland however, went a step further by allowing the state attorney general to take legal action against drug makers that price gouge and to obtain restitution for state health programs and patients. In April, a federal appeals court struck down Maryland’s law as unconstitutional, ruling that the measure violates the federal commerce clause because it attempts to regulate price transactions. The law remains in limbo while the legal challenge continues.
The recent drug price transparency laws are necessary first steps to enable states to better understand and anticipate price increases, said Jennifer Reck, project director for the National Academy for State Health Policy.
“Faced with unsustainable prescription drug price increases, states are passing laws to create greater transparency and accountability around pricing,” Ms. Reck said in an interview.
However, with the exception of Maryland’s measure, the laws are limited because they do not empower states to take action when companies dramatically increase drug prices, she said. It’s also unclear what impact the greater transparency requirements will have on the marketplace, she added.
Gerard F. Anderson, PhD, a health policy and management professor at Johns Hopkins University in Baltimore, agreed that the drug price transparency laws are a good start. But a second component is needed so that states can take effective action, he said in an interview.
“Price transparency, alone, doesn’t do anything,” he said. “What you need to do is couple price transparency with some kind of other activity that would allow you to actually lower the price.”
Some of those other activities include prohibiting rebates by PBMs, rate setting, or establishing a maximum amount that patients should pay for certain drugs, he suggested.
Some states are already exploring policies that go beyond transparency to allow states to take action against overpricing of medications, Ms. Reck noted. New Jersey and Minnesota, for example, have introduced rate-setting bills that would create cost commissions with the authority to establish payment rates for drugs determined to be unjustifiably priced.
To truly lower drug costs for patients, state laws must be comprehensive and address the various rungs of the pharmaceutical supply chain, Ms. VanderVeer said. PhRMA supported Louisiana’s recent drug price transparency law, but has opposed laws in Vermont, California, and Nevada.
“If it is transparency legislation and other policies that actually help patients afford their medicines and make sure that they are getting access to the same discounts and rebates their insurers and PMBs are getting, then yes, we support it,” Ms. VanderVeer said in an interview. “Unfortunately, a lot of the so-called ‘transparency’ bills that have passed over the last few years do no such thing. All they do is look at one part of the supply chain – the inventors and manufacturers of the medicines – and completely leave out those in the middle and have no provisions in them that will help patients access or afford their medicines.”
Connecticut’s law goes into effect in January 2020.
Connecticut is the latest state to enact a so-called drug price transparency law that imposes reporting requirements on drug makers, health insurers, and pharmacy benefit managers (PBMs).
The new requirements, signed into law by Connecticut Governor Dannel Malloy (D) on May 31, call on drug manufacturers to provide information about significant drug cost increases, including the factors that triggered the price hike and information about the drug’s development costs and capital expenditures. As part of the law, PBMs must report the volume of formulary rebates received from drug makers, including the portion provided to health insurers.
Connecticut’s law is the first to require that health insurers submit data about the most frequently prescribed and highest-cost drugs, as well as information about the impact of drug costs on the plan and its members.
Connecticut Comptroller Kevin Lembo called the law “groundbreaking” and said enactment of the measure is a victory for patients who pay outrageous prices while corporations are “enriched by big discounts.
“The extreme wealth exchange between corporate giants from pharmaceutical manufacturers to pharmacy benefit managers to insurance companies, will no longer happen in the dark,” Mr. Lembo said in a statement. “This legislative victory is a groundbreaking step, but the fight for fairness has only just begun as we continue the fight for relief at the pharmacy counter.”
Priscilla VanderVeer, a spokeswoman for Pharmaceutical Research and Manufacturers of America (PhRMA), said Connecticut’s law has some positive features, but does not go far enough in ensuring savings are passed along to patients.
“While we are glad that this legislation will require middlemen to report what portion of rebates are being passed on to consumers, we are disappointed that the final version of the legislation does not include provisions that would ensure steep rebates given to middlemen are passed on to consumers,” Ms. VanderVeer said in an interview. “Making sure that patients who share the cost of their prescription medicines also share the savings is one of the most important things we can do to provide relief for patients facing higher out-of-pocket costs at the pharmacy counter. We are committed to working with Connecticut lawmakers and other health care stakeholders to craft a solution that will provide patients with the solutions that matter the most to them.”
At least seven other states have passed similar laws that aim to expose questionable medication pricing and compel drug makers to provide the reasoning behind their cost decisions. Between 2016 and 2018, drug price transparency laws were enacted in California, Louisiana, Nevada, New York, Oregon, Maryland, and Vermont. Maine meanwhile, has enacted legislation that requires the development of a plan to collect data from manufacturers.
The majority of drug price transparency laws require drug makers to report and justify dramatic drug price increases to the state. Maryland however, went a step further by allowing the state attorney general to take legal action against drug makers that price gouge and to obtain restitution for state health programs and patients. In April, a federal appeals court struck down Maryland’s law as unconstitutional, ruling that the measure violates the federal commerce clause because it attempts to regulate price transactions. The law remains in limbo while the legal challenge continues.
The recent drug price transparency laws are necessary first steps to enable states to better understand and anticipate price increases, said Jennifer Reck, project director for the National Academy for State Health Policy.
“Faced with unsustainable prescription drug price increases, states are passing laws to create greater transparency and accountability around pricing,” Ms. Reck said in an interview.
However, with the exception of Maryland’s measure, the laws are limited because they do not empower states to take action when companies dramatically increase drug prices, she said. It’s also unclear what impact the greater transparency requirements will have on the marketplace, she added.
Gerard F. Anderson, PhD, a health policy and management professor at Johns Hopkins University in Baltimore, agreed that the drug price transparency laws are a good start. But a second component is needed so that states can take effective action, he said in an interview.
“Price transparency, alone, doesn’t do anything,” he said. “What you need to do is couple price transparency with some kind of other activity that would allow you to actually lower the price.”
Some of those other activities include prohibiting rebates by PBMs, rate setting, or establishing a maximum amount that patients should pay for certain drugs, he suggested.
Some states are already exploring policies that go beyond transparency to allow states to take action against overpricing of medications, Ms. Reck noted. New Jersey and Minnesota, for example, have introduced rate-setting bills that would create cost commissions with the authority to establish payment rates for drugs determined to be unjustifiably priced.
To truly lower drug costs for patients, state laws must be comprehensive and address the various rungs of the pharmaceutical supply chain, Ms. VanderVeer said. PhRMA supported Louisiana’s recent drug price transparency law, but has opposed laws in Vermont, California, and Nevada.
“If it is transparency legislation and other policies that actually help patients afford their medicines and make sure that they are getting access to the same discounts and rebates their insurers and PMBs are getting, then yes, we support it,” Ms. VanderVeer said in an interview. “Unfortunately, a lot of the so-called ‘transparency’ bills that have passed over the last few years do no such thing. All they do is look at one part of the supply chain – the inventors and manufacturers of the medicines – and completely leave out those in the middle and have no provisions in them that will help patients access or afford their medicines.”
Connecticut’s law goes into effect in January 2020.
Using Stroke Order Sets to Improve Compliance With Quality Measures for Ischemic Stroke Admissions
Stroke and cardiovascular disease (CVD) create a heavy economic burden on the health care system in the US.1 About 795,000 people have a stroke in the US each year. In 2013, stroke was the cause of 1 in every 20 deaths in the US.2 On average, someone in the US has a stroke every 40 seconds, and someone dies of one about every 4 minutes.3 Stroke also accounts for 889,000 hospitalizations per year.4,5
Stroke has been studied widely, and evidence-based guidelines have been created for the management of stroke. Despite these published guidelines for stroke care, inconsistencies in stroke management of veterans still exist. These inconsistencies led to the creation of guidelines that include quality measurements for the care of veterans with stroke.
Several campaigns have been mounted to bolster quality care for veterans with ischemic stroke. These include the Primary Stroke Center Certification by The Joint Commission (JC),6 Get With the Guidelines by the American Stroke Association,7 the Paul Coverdell Registry by the Centers for Disease Control and Prevention,8 and other efforts by the National Quality Forum (NQF) and the Centers for Medicare and Medicaid Services.9 These organizations have independently and collaboratively established quality metrics associated with health care delivery for the care of veterans with stroke. Some of these metrics have been distinguished as performance measures, or metrics that are suitable for public reporting, and may be used for comparing institutions and rewarding those who meet specific thresholds (ie, pay for performance).10
The aim of this project was to increase compliance at the Atlanta VA Medical Center (VAMC) in Decatur, Georgia, with JC National Quality Measures for the care of veterans with ischemic stroke, thus providing optimal care for veterans admitted for ischemic stroke management.
There are 3 phases in the management of a patient with a stroke: stroke presentation, admission/management, and discharge. This project focused on the admission/management phase. The stroke presentation phase is completed in the emergency department (ED), and the discharge phase has a check list for stroke, including atrial fibrillation (AF) and counseling prior to discharge. Data from the check list and counseling were not included in this project.
Specific attention was given to the following JC measures: stroke (STK) 1, STK 5, and STK 10 because the Atlanta VAMC was below the national average for these core measures for fiscal year 2015. Compliance was accomplished by creating order sets for the admission and subsequent care of veterans with ischemic stroke, tracking order set usage, and reporting regularly to the medicine/admitting team members on use rates and meeting quality measures. This project underwent the quality vs research review process and was determined to be a quality improvement (QI) project, so the project did not require institutional review board approval.
Methods
At the Atlanta VAMC, all patients admitted for stroke workup or management are admitted to the medicine service. The medicine admitting teams are composed of an attending physician, a medicine resident, a nurse practitioner (NP), a pharmacist, and 2 interns; and the hospitalist team composed of a hospitalist. The project began January 1, 2016, and ended December 31, 2016.
The hospitalist created evidence-based admission orders for all patients admitted for stroke or transient ischemic attack (TIA).The measures used were from the JC Specification Manual for Joint Commission National Quality as well as The American College of Cardiology/American Heart Association classification of care metrics.5
The order sets were reviewed and confirmed by a neurologist. The JC quality measures required for the care of patients admitted for stroke management were embedded in these order sets. These order sets were placed directly under the general admission orders in the Computerized Patient Record System (CPRS)
The quality measures included:
- STK 1: Veteran admitted for stroke received venous thromboembolic (VTE) prophylaxis in a timely manner. Pharmacologic management for VTE prophylaxis with subcutaneous low-molecular weight heparin and/or application of bilateral sequential compression devices were tracked.
- STK 5: Veteran admitted for stroke administered antithrombotic therapy by end of hospital day 2. Aspirin, aspirin/dipyridamole, and ticlopidine were tracked.
- STK 10: Veteran admitted for stroke assessed for rehabilitation services during admission. Physical therapy and occupational therapy consult placements were tracked. Quality measures, such as administration of tissue plasminogen activator (tPA), were not embedded in the order set because veterans who met the criteria for tPA were immediately administered tPA in the ED or transferred to the closest stroke center.
In this QI project, only quality measures that had to be completed in the inpatient setting were included. Quality measures such as tPA administration, National Institutes of Health (NIH) Stroke Scale timely documentation, swallow screen prior to po intake, and stroke transfers were completed in the ED prior to clearance for admission, so these were not included in the project. The Atlanta VAMC ED has protocols to care for these patients, but they do not have order sets with markers that could trace their usage.
All admission orders placed were reviewed by a QI team to check whether the stroke order set had been used. The ability to determine order set use was accomplished by adding the unique identifier Stroke Order Set Marker, which allowed for querying using structured query language (SQL) within the Corporate Data Warehouse. 
Next, all admissions were checked through chart review for compliance with quality measures. Admissions that had not been completed for all quality measures were identified, and the physicians or NPs caring for those veterans were alerted. These order sets were supposed to be used during admission of all patients admitted for stroke management or workup; however, some patients were admitted without the use of the order sets.
The successful completion of the quality measures were then compared between the groups of patients admitted using the order set and the group of patients in which the order set was not used at their admission. The physicians were provided acceptable reasons, including contraindications to certain medications such as patient history of allergy. The admitting physician made decisions on the antiplatelet medications to use or on neurology recommendations. The neurology department was consulted on all patients who had acute or subacute ischemic stroke findings on magnetic resonance imaging (MRI).
At the beginning of the month, internal medicine residents from Emory University and Morehouse School of Medicine received orientation on the use of the stroke order set from the team NP and chief resident. Tips on how to use the CPRS and how to access the stroke order sets also were created. 
One challenge the project faced was the continuous change in the admitting team pool: Some residents did not remember to use the stroke order sets. 
Results
Of 323 admitted patients with stroke, 93 admissions were entered using the stroke order set. Out of these completed orders, 85 (91%) veterans admitted for ischemic stroke or TIA management received timely VTE prophylaxis, and 8 (9%) veterans did not. Of the 230 admissions completed without using the stroke order set, 167 (73%) veterans received timely VTE prophylaxis, and 63 (28%) veterans did not. Additionally out of the 93 veterans admitted using the stroke order set, 74 (80%) veterans admitted for the management of ischemic stroke received antithrombotic therapy by end of hospital day 2, whereas 19 (20%) veterans did not, and there were no clear contraindications documented as to why.
For veterans admitted without using the order set, 167 (73%) veterans admitted for the management of ischemic stroke received antithrombotic therapy by the end of hospital day 2, whereas 76 (33%) veterans did not. Last, 90 (97%) of the 93 veterans admitted for stroke workup using the order set were assessed for rehabilitation services during admission, whereas 3 (3%) were not. For the veterans who were admitted without using the stroke order set, 162 (70%) were assessed for rehabilitation services during admission, whereas 68 (30%) were not.
Out of 969 compliance measures looked at, 237 measures were missed and 732 measures were appropriately completed irrespective of whether the stroke order set was used. Out of the 279 admissions where the stroke order set was used, 249 (89%) quality measures were met. 
The study threshold for meeting the standards was the national average for 2015, which was 91.1% for the administration of VTE prophylaxis in a timely manner, 97.9% for administering antithrombotic therapy by end of hospital day 2, and 94.2% for assessment of the patient by rehabilitation services during the admission.
Discussion
Despite the repeated training and orientation, compliance to the order set usage was not optimal, likely secondary to a frequent change in the pool of admitting physicians using the order set. Also, the order set was new to staff, thus, admitting physicians sometimes forgot to use them. The next step in this project will be to create an order set for the ED with markers for tracing usage. These order sets will include all quality measures that need to be completed in the ED, such as the NIH Stroke Scale timely documentation, tPA administration data, swallow screen prior to po intake, and stroke transfers.
This QI project also streamlined the process for stroke admissions. With the creation of the order set, all orders needed for stroke were available to the admitting physician, resulting in less need for searching the order individually from a large pool of orders (Figures 3 and 4).
Several reputable institutions have quality metrics and performance measures typically focused on processes of care based on specific clinical guidelines recommendations. Clinical guidelines are usually based on sufficient evidence that failure to provide the recommended care is likely to result in suboptimal clinical outcomes. Stroke quality measure compliance is part of the Reporting Hospital Quality Data for Annual Payment Update (RHQDAPU) initiative, and most hospitals will be required to report these measures in order to receive full Medicare payments.11
Limitations
Limitations of this study relate to CPRS functions, which must be specifically activated at different VA sites in order to enable the use of these functions. Also, the successful creation of these order sets depended on the information specialist’s knowledge of the capabilities of the CPRS.
Conclusion
Gaps in practice and recommended guidelines can be bridged by creating standardized admission orders embedded with required quality measures. The Atlanta VAMC project showed that the use of a standardized stroke admission order set significantly improved compliance to quality measures for veterans admitted for ischemic stroke management. This is consistent with a study completed in the ED, which showed that for veterans hospitalized for acute ischemic stroke, electronic order set use was associated with increased use of IV tPA.12 Creating order sets can be challenging, but if these barriers can be overcome, with the first order set, similar templates can be used to create order sets for other clinical conditions, such as heart failure, sepsis, and chronic obstructive pulmonary disease exacerbation.
1. Writing Group Members, Mozaffarian D, Benjamin EJ, Go AS, et al; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics—2016 update: a report from the American Heart Association. Circulation. 2016;133(4):447-454.
2. Centers for Disease Control and Prevention. Vital signs: recent trends in stroke death rates–United States, 2000-2015. https://www.cdc.gov/mmwr/volumes/66/wr/mm6635e1.htm. Published September 8, 2017. Accessed June 14, 2018.
3. Benjamin EJ, Blaha MJ, Chiuve SE, et al; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2017 update: a report from the American Heart Association. Circulation. 2017;135(10):e229-e445.
4. Lloyd-Jones D, Adams R, Carnethon M, et al; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2009 update: a report from the American heart association statistics committee and stroke statistics subcommittee. Circulation. 2009;119(3):480-486.
5. Poisson SN, Josephson SA. Quality measures in stroke. Neurohospitalist. 2011;1(2):71-77.
6. The Joint Commission. Primary Stroke Centers—Stroke Performance Measurement. https://www.jointcommission.org/performance_ measurement.aspx. Accessed June 14, 2018.
7. American Stroke Association. Get with the guidelines–stroke. http://www.heart.org/HEARTORG/Professional/GetWithTheGuidelines/GetWithTheGuidelines-Stroke/Get-With-The-Guidelines-Stroke-Overview_UCM_308021_Article.jsp#.WyKre1VKiUk. Accessed June 14, 2018.
8. Centers for Disease Control and Prevention. The Paul Coverdell National Acute Stroke Registry. www.cdc.gov/DHDSP/stroke_registry.htm. Published March 13, 2008.
9. Reeves MJ, Parker C, Fonarow GC, Smith EE, Schwamm LH. Development of stroke performance measures: definitions, methods, and current measures. Stroke. 2010;41(7):1573-1578.
10. American College of Cardiology/American Heart Association Task Force on Performance Measures, Bonow RO, Masoudi FA, et al. ACC/AHA classification of care metrics: performance measures and quality metrics: a report of the American College of Cardiology/American Heart Association Task Force on performance measures. Circulation. 2008;118(24):2662-2666.
11. Centers for Medicare and Medicaid Services. Reporting Hospital Quality Data for Annual Payment Update https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HospitalQualityInits/downloads/HospitalFactSheetAP.pdf. Published November 2004. Accessed June 14, 2018.
12. Ballard DW, Kim AS, Huang J, et al; KP CREST Network Investigators. Implementation of computerized physician order entry is associated with increased thrombolytic administration for emergency department veterans with acute ischemic stroke. Ann Emerg Med. 2015;66(6):601-610.
Stroke and cardiovascular disease (CVD) create a heavy economic burden on the health care system in the US.1 About 795,000 people have a stroke in the US each year. In 2013, stroke was the cause of 1 in every 20 deaths in the US.2 On average, someone in the US has a stroke every 40 seconds, and someone dies of one about every 4 minutes.3 Stroke also accounts for 889,000 hospitalizations per year.4,5
Stroke has been studied widely, and evidence-based guidelines have been created for the management of stroke. Despite these published guidelines for stroke care, inconsistencies in stroke management of veterans still exist. These inconsistencies led to the creation of guidelines that include quality measurements for the care of veterans with stroke.
Several campaigns have been mounted to bolster quality care for veterans with ischemic stroke. These include the Primary Stroke Center Certification by The Joint Commission (JC),6 Get With the Guidelines by the American Stroke Association,7 the Paul Coverdell Registry by the Centers for Disease Control and Prevention,8 and other efforts by the National Quality Forum (NQF) and the Centers for Medicare and Medicaid Services.9 These organizations have independently and collaboratively established quality metrics associated with health care delivery for the care of veterans with stroke. Some of these metrics have been distinguished as performance measures, or metrics that are suitable for public reporting, and may be used for comparing institutions and rewarding those who meet specific thresholds (ie, pay for performance).10
The aim of this project was to increase compliance at the Atlanta VA Medical Center (VAMC) in Decatur, Georgia, with JC National Quality Measures for the care of veterans with ischemic stroke, thus providing optimal care for veterans admitted for ischemic stroke management.
There are 3 phases in the management of a patient with a stroke: stroke presentation, admission/management, and discharge. This project focused on the admission/management phase. The stroke presentation phase is completed in the emergency department (ED), and the discharge phase has a check list for stroke, including atrial fibrillation (AF) and counseling prior to discharge. Data from the check list and counseling were not included in this project.
Specific attention was given to the following JC measures: stroke (STK) 1, STK 5, and STK 10 because the Atlanta VAMC was below the national average for these core measures for fiscal year 2015. Compliance was accomplished by creating order sets for the admission and subsequent care of veterans with ischemic stroke, tracking order set usage, and reporting regularly to the medicine/admitting team members on use rates and meeting quality measures. This project underwent the quality vs research review process and was determined to be a quality improvement (QI) project, so the project did not require institutional review board approval.
Methods
At the Atlanta VAMC, all patients admitted for stroke workup or management are admitted to the medicine service. The medicine admitting teams are composed of an attending physician, a medicine resident, a nurse practitioner (NP), a pharmacist, and 2 interns; and the hospitalist team composed of a hospitalist. The project began January 1, 2016, and ended December 31, 2016.
The hospitalist created evidence-based admission orders for all patients admitted for stroke or transient ischemic attack (TIA).The measures used were from the JC Specification Manual for Joint Commission National Quality as well as The American College of Cardiology/American Heart Association classification of care metrics.5
The order sets were reviewed and confirmed by a neurologist. The JC quality measures required for the care of patients admitted for stroke management were embedded in these order sets. These order sets were placed directly under the general admission orders in the Computerized Patient Record System (CPRS)
The quality measures included:
- STK 1: Veteran admitted for stroke received venous thromboembolic (VTE) prophylaxis in a timely manner. Pharmacologic management for VTE prophylaxis with subcutaneous low-molecular weight heparin and/or application of bilateral sequential compression devices were tracked.
- STK 5: Veteran admitted for stroke administered antithrombotic therapy by end of hospital day 2. Aspirin, aspirin/dipyridamole, and ticlopidine were tracked.
- STK 10: Veteran admitted for stroke assessed for rehabilitation services during admission. Physical therapy and occupational therapy consult placements were tracked. Quality measures, such as administration of tissue plasminogen activator (tPA), were not embedded in the order set because veterans who met the criteria for tPA were immediately administered tPA in the ED or transferred to the closest stroke center.
In this QI project, only quality measures that had to be completed in the inpatient setting were included. Quality measures such as tPA administration, National Institutes of Health (NIH) Stroke Scale timely documentation, swallow screen prior to po intake, and stroke transfers were completed in the ED prior to clearance for admission, so these were not included in the project. The Atlanta VAMC ED has protocols to care for these patients, but they do not have order sets with markers that could trace their usage.
All admission orders placed were reviewed by a QI team to check whether the stroke order set had been used. The ability to determine order set use was accomplished by adding the unique identifier Stroke Order Set Marker, which allowed for querying using structured query language (SQL) within the Corporate Data Warehouse.
Next, all admissions were checked through chart review for compliance with quality measures. Admissions that had not been completed for all quality measures were identified, and the physicians or NPs caring for those veterans were alerted. These order sets were supposed to be used during admission of all patients admitted for stroke management or workup; however, some patients were admitted without the use of the order sets.
The successful completion of the quality measures were then compared between the groups of patients admitted using the order set and the group of patients in which the order set was not used at their admission. The physicians were provided acceptable reasons, including contraindications to certain medications such as patient history of allergy. The admitting physician made decisions on the antiplatelet medications to use or on neurology recommendations. The neurology department was consulted on all patients who had acute or subacute ischemic stroke findings on magnetic resonance imaging (MRI).
At the beginning of the month, internal medicine residents from Emory University and Morehouse School of Medicine received orientation on the use of the stroke order set from the team NP and chief resident. Tips on how to use the CPRS and how to access the stroke order sets also were created.
One challenge the project faced was the continuous change in the admitting team pool: Some residents did not remember to use the stroke order sets.
Results
Of 323 admitted patients with stroke, 93 admissions were entered using the stroke order set. Out of these completed orders, 85 (91%) veterans admitted for ischemic stroke or TIA management received timely VTE prophylaxis, and 8 (9%) veterans did not. Of the 230 admissions completed without using the stroke order set, 167 (73%) veterans received timely VTE prophylaxis, and 63 (28%) veterans did not. Additionally out of the 93 veterans admitted using the stroke order set, 74 (80%) veterans admitted for the management of ischemic stroke received antithrombotic therapy by end of hospital day 2, whereas 19 (20%) veterans did not, and there were no clear contraindications documented as to why.
For veterans admitted without using the order set, 167 (73%) veterans admitted for the management of ischemic stroke received antithrombotic therapy by the end of hospital day 2, whereas 76 (33%) veterans did not. Last, 90 (97%) of the 93 veterans admitted for stroke workup using the order set were assessed for rehabilitation services during admission, whereas 3 (3%) were not. For the veterans who were admitted without using the stroke order set, 162 (70%) were assessed for rehabilitation services during admission, whereas 68 (30%) were not.
Out of 969 compliance measures looked at, 237 measures were missed and 732 measures were appropriately completed irrespective of whether the stroke order set was used. Out of the 279 admissions where the stroke order set was used, 249 (89%) quality measures were met.
The study threshold for meeting the standards was the national average for 2015, which was 91.1% for the administration of VTE prophylaxis in a timely manner, 97.9% for administering antithrombotic therapy by end of hospital day 2, and 94.2% for assessment of the patient by rehabilitation services during the admission.
Discussion
Despite the repeated training and orientation, compliance to the order set usage was not optimal, likely secondary to a frequent change in the pool of admitting physicians using the order set. Also, the order set was new to staff, thus, admitting physicians sometimes forgot to use them. The next step in this project will be to create an order set for the ED with markers for tracing usage. These order sets will include all quality measures that need to be completed in the ED, such as the NIH Stroke Scale timely documentation, tPA administration data, swallow screen prior to po intake, and stroke transfers.
This QI project also streamlined the process for stroke admissions. With the creation of the order set, all orders needed for stroke were available to the admitting physician, resulting in less need for searching the order individually from a large pool of orders (Figures 3 and 4).
Several reputable institutions have quality metrics and performance measures typically focused on processes of care based on specific clinical guidelines recommendations. Clinical guidelines are usually based on sufficient evidence that failure to provide the recommended care is likely to result in suboptimal clinical outcomes. Stroke quality measure compliance is part of the Reporting Hospital Quality Data for Annual Payment Update (RHQDAPU) initiative, and most hospitals will be required to report these measures in order to receive full Medicare payments.11
Limitations
Limitations of this study relate to CPRS functions, which must be specifically activated at different VA sites in order to enable the use of these functions. Also, the successful creation of these order sets depended on the information specialist’s knowledge of the capabilities of the CPRS.
Conclusion
Gaps in practice and recommended guidelines can be bridged by creating standardized admission orders embedded with required quality measures. The Atlanta VAMC project showed that the use of a standardized stroke admission order set significantly improved compliance to quality measures for veterans admitted for ischemic stroke management. This is consistent with a study completed in the ED, which showed that for veterans hospitalized for acute ischemic stroke, electronic order set use was associated with increased use of IV tPA.12 Creating order sets can be challenging, but if these barriers can be overcome, with the first order set, similar templates can be used to create order sets for other clinical conditions, such as heart failure, sepsis, and chronic obstructive pulmonary disease exacerbation.
Stroke and cardiovascular disease (CVD) create a heavy economic burden on the health care system in the US.1 About 795,000 people have a stroke in the US each year. In 2013, stroke was the cause of 1 in every 20 deaths in the US.2 On average, someone in the US has a stroke every 40 seconds, and someone dies of one about every 4 minutes.3 Stroke also accounts for 889,000 hospitalizations per year.4,5
Stroke has been studied widely, and evidence-based guidelines have been created for the management of stroke. Despite these published guidelines for stroke care, inconsistencies in stroke management of veterans still exist. These inconsistencies led to the creation of guidelines that include quality measurements for the care of veterans with stroke.
Several campaigns have been mounted to bolster quality care for veterans with ischemic stroke. These include the Primary Stroke Center Certification by The Joint Commission (JC),6 Get With the Guidelines by the American Stroke Association,7 the Paul Coverdell Registry by the Centers for Disease Control and Prevention,8 and other efforts by the National Quality Forum (NQF) and the Centers for Medicare and Medicaid Services.9 These organizations have independently and collaboratively established quality metrics associated with health care delivery for the care of veterans with stroke. Some of these metrics have been distinguished as performance measures, or metrics that are suitable for public reporting, and may be used for comparing institutions and rewarding those who meet specific thresholds (ie, pay for performance).10
The aim of this project was to increase compliance at the Atlanta VA Medical Center (VAMC) in Decatur, Georgia, with JC National Quality Measures for the care of veterans with ischemic stroke, thus providing optimal care for veterans admitted for ischemic stroke management.
There are 3 phases in the management of a patient with a stroke: stroke presentation, admission/management, and discharge. This project focused on the admission/management phase. The stroke presentation phase is completed in the emergency department (ED), and the discharge phase has a check list for stroke, including atrial fibrillation (AF) and counseling prior to discharge. Data from the check list and counseling were not included in this project.
Specific attention was given to the following JC measures: stroke (STK) 1, STK 5, and STK 10 because the Atlanta VAMC was below the national average for these core measures for fiscal year 2015. Compliance was accomplished by creating order sets for the admission and subsequent care of veterans with ischemic stroke, tracking order set usage, and reporting regularly to the medicine/admitting team members on use rates and meeting quality measures. This project underwent the quality vs research review process and was determined to be a quality improvement (QI) project, so the project did not require institutional review board approval.
Methods
At the Atlanta VAMC, all patients admitted for stroke workup or management are admitted to the medicine service. The medicine admitting teams are composed of an attending physician, a medicine resident, a nurse practitioner (NP), a pharmacist, and 2 interns; and the hospitalist team composed of a hospitalist. The project began January 1, 2016, and ended December 31, 2016.
The hospitalist created evidence-based admission orders for all patients admitted for stroke or transient ischemic attack (TIA).The measures used were from the JC Specification Manual for Joint Commission National Quality as well as The American College of Cardiology/American Heart Association classification of care metrics.5
The order sets were reviewed and confirmed by a neurologist. The JC quality measures required for the care of patients admitted for stroke management were embedded in these order sets. These order sets were placed directly under the general admission orders in the Computerized Patient Record System (CPRS)
The quality measures included:
- STK 1: Veteran admitted for stroke received venous thromboembolic (VTE) prophylaxis in a timely manner. Pharmacologic management for VTE prophylaxis with subcutaneous low-molecular weight heparin and/or application of bilateral sequential compression devices were tracked.
- STK 5: Veteran admitted for stroke administered antithrombotic therapy by end of hospital day 2. Aspirin, aspirin/dipyridamole, and ticlopidine were tracked.
- STK 10: Veteran admitted for stroke assessed for rehabilitation services during admission. Physical therapy and occupational therapy consult placements were tracked. Quality measures, such as administration of tissue plasminogen activator (tPA), were not embedded in the order set because veterans who met the criteria for tPA were immediately administered tPA in the ED or transferred to the closest stroke center.
In this QI project, only quality measures that had to be completed in the inpatient setting were included. Quality measures such as tPA administration, National Institutes of Health (NIH) Stroke Scale timely documentation, swallow screen prior to po intake, and stroke transfers were completed in the ED prior to clearance for admission, so these were not included in the project. The Atlanta VAMC ED has protocols to care for these patients, but they do not have order sets with markers that could trace their usage.
All admission orders placed were reviewed by a QI team to check whether the stroke order set had been used. The ability to determine order set use was accomplished by adding the unique identifier Stroke Order Set Marker, which allowed for querying using structured query language (SQL) within the Corporate Data Warehouse.
Next, all admissions were checked through chart review for compliance with quality measures. Admissions that had not been completed for all quality measures were identified, and the physicians or NPs caring for those veterans were alerted. These order sets were supposed to be used during admission of all patients admitted for stroke management or workup; however, some patients were admitted without the use of the order sets.
The successful completion of the quality measures were then compared between the groups of patients admitted using the order set and the group of patients in which the order set was not used at their admission. The physicians were provided acceptable reasons, including contraindications to certain medications such as patient history of allergy. The admitting physician made decisions on the antiplatelet medications to use or on neurology recommendations. The neurology department was consulted on all patients who had acute or subacute ischemic stroke findings on magnetic resonance imaging (MRI).
At the beginning of the month, internal medicine residents from Emory University and Morehouse School of Medicine received orientation on the use of the stroke order set from the team NP and chief resident. Tips on how to use the CPRS and how to access the stroke order sets also were created.
One challenge the project faced was the continuous change in the admitting team pool: Some residents did not remember to use the stroke order sets.
Results
Of 323 admitted patients with stroke, 93 admissions were entered using the stroke order set. Out of these completed orders, 85 (91%) veterans admitted for ischemic stroke or TIA management received timely VTE prophylaxis, and 8 (9%) veterans did not. Of the 230 admissions completed without using the stroke order set, 167 (73%) veterans received timely VTE prophylaxis, and 63 (28%) veterans did not. Additionally out of the 93 veterans admitted using the stroke order set, 74 (80%) veterans admitted for the management of ischemic stroke received antithrombotic therapy by end of hospital day 2, whereas 19 (20%) veterans did not, and there were no clear contraindications documented as to why.
For veterans admitted without using the order set, 167 (73%) veterans admitted for the management of ischemic stroke received antithrombotic therapy by the end of hospital day 2, whereas 76 (33%) veterans did not. Last, 90 (97%) of the 93 veterans admitted for stroke workup using the order set were assessed for rehabilitation services during admission, whereas 3 (3%) were not. For the veterans who were admitted without using the stroke order set, 162 (70%) were assessed for rehabilitation services during admission, whereas 68 (30%) were not.
Out of 969 compliance measures looked at, 237 measures were missed and 732 measures were appropriately completed irrespective of whether the stroke order set was used. Out of the 279 admissions where the stroke order set was used, 249 (89%) quality measures were met.
The study threshold for meeting the standards was the national average for 2015, which was 91.1% for the administration of VTE prophylaxis in a timely manner, 97.9% for administering antithrombotic therapy by end of hospital day 2, and 94.2% for assessment of the patient by rehabilitation services during the admission.
Discussion
Despite the repeated training and orientation, compliance to the order set usage was not optimal, likely secondary to a frequent change in the pool of admitting physicians using the order set. Also, the order set was new to staff, thus, admitting physicians sometimes forgot to use them. The next step in this project will be to create an order set for the ED with markers for tracing usage. These order sets will include all quality measures that need to be completed in the ED, such as the NIH Stroke Scale timely documentation, tPA administration data, swallow screen prior to po intake, and stroke transfers.
This QI project also streamlined the process for stroke admissions. With the creation of the order set, all orders needed for stroke were available to the admitting physician, resulting in less need for searching the order individually from a large pool of orders (Figures 3 and 4).
Several reputable institutions have quality metrics and performance measures typically focused on processes of care based on specific clinical guidelines recommendations. Clinical guidelines are usually based on sufficient evidence that failure to provide the recommended care is likely to result in suboptimal clinical outcomes. Stroke quality measure compliance is part of the Reporting Hospital Quality Data for Annual Payment Update (RHQDAPU) initiative, and most hospitals will be required to report these measures in order to receive full Medicare payments.11
Limitations
Limitations of this study relate to CPRS functions, which must be specifically activated at different VA sites in order to enable the use of these functions. Also, the successful creation of these order sets depended on the information specialist’s knowledge of the capabilities of the CPRS.
Conclusion
Gaps in practice and recommended guidelines can be bridged by creating standardized admission orders embedded with required quality measures. The Atlanta VAMC project showed that the use of a standardized stroke admission order set significantly improved compliance to quality measures for veterans admitted for ischemic stroke management. This is consistent with a study completed in the ED, which showed that for veterans hospitalized for acute ischemic stroke, electronic order set use was associated with increased use of IV tPA.12 Creating order sets can be challenging, but if these barriers can be overcome, with the first order set, similar templates can be used to create order sets for other clinical conditions, such as heart failure, sepsis, and chronic obstructive pulmonary disease exacerbation.
1. Writing Group Members, Mozaffarian D, Benjamin EJ, Go AS, et al; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics—2016 update: a report from the American Heart Association. Circulation. 2016;133(4):447-454.
2. Centers for Disease Control and Prevention. Vital signs: recent trends in stroke death rates–United States, 2000-2015. https://www.cdc.gov/mmwr/volumes/66/wr/mm6635e1.htm. Published September 8, 2017. Accessed June 14, 2018.
3. Benjamin EJ, Blaha MJ, Chiuve SE, et al; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2017 update: a report from the American Heart Association. Circulation. 2017;135(10):e229-e445.
4. Lloyd-Jones D, Adams R, Carnethon M, et al; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2009 update: a report from the American heart association statistics committee and stroke statistics subcommittee. Circulation. 2009;119(3):480-486.
5. Poisson SN, Josephson SA. Quality measures in stroke. Neurohospitalist. 2011;1(2):71-77.
6. The Joint Commission. Primary Stroke Centers—Stroke Performance Measurement. https://www.jointcommission.org/performance_ measurement.aspx. Accessed June 14, 2018.
7. American Stroke Association. Get with the guidelines–stroke. http://www.heart.org/HEARTORG/Professional/GetWithTheGuidelines/GetWithTheGuidelines-Stroke/Get-With-The-Guidelines-Stroke-Overview_UCM_308021_Article.jsp#.WyKre1VKiUk. Accessed June 14, 2018.
8. Centers for Disease Control and Prevention. The Paul Coverdell National Acute Stroke Registry. www.cdc.gov/DHDSP/stroke_registry.htm. Published March 13, 2008.
9. Reeves MJ, Parker C, Fonarow GC, Smith EE, Schwamm LH. Development of stroke performance measures: definitions, methods, and current measures. Stroke. 2010;41(7):1573-1578.
10. American College of Cardiology/American Heart Association Task Force on Performance Measures, Bonow RO, Masoudi FA, et al. ACC/AHA classification of care metrics: performance measures and quality metrics: a report of the American College of Cardiology/American Heart Association Task Force on performance measures. Circulation. 2008;118(24):2662-2666.
11. Centers for Medicare and Medicaid Services. Reporting Hospital Quality Data for Annual Payment Update https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HospitalQualityInits/downloads/HospitalFactSheetAP.pdf. Published November 2004. Accessed June 14, 2018.
12. Ballard DW, Kim AS, Huang J, et al; KP CREST Network Investigators. Implementation of computerized physician order entry is associated with increased thrombolytic administration for emergency department veterans with acute ischemic stroke. Ann Emerg Med. 2015;66(6):601-610.
1. Writing Group Members, Mozaffarian D, Benjamin EJ, Go AS, et al; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics—2016 update: a report from the American Heart Association. Circulation. 2016;133(4):447-454.
2. Centers for Disease Control and Prevention. Vital signs: recent trends in stroke death rates–United States, 2000-2015. https://www.cdc.gov/mmwr/volumes/66/wr/mm6635e1.htm. Published September 8, 2017. Accessed June 14, 2018.
3. Benjamin EJ, Blaha MJ, Chiuve SE, et al; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2017 update: a report from the American Heart Association. Circulation. 2017;135(10):e229-e445.
4. Lloyd-Jones D, Adams R, Carnethon M, et al; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2009 update: a report from the American heart association statistics committee and stroke statistics subcommittee. Circulation. 2009;119(3):480-486.
5. Poisson SN, Josephson SA. Quality measures in stroke. Neurohospitalist. 2011;1(2):71-77.
6. The Joint Commission. Primary Stroke Centers—Stroke Performance Measurement. https://www.jointcommission.org/performance_ measurement.aspx. Accessed June 14, 2018.
7. American Stroke Association. Get with the guidelines–stroke. http://www.heart.org/HEARTORG/Professional/GetWithTheGuidelines/GetWithTheGuidelines-Stroke/Get-With-The-Guidelines-Stroke-Overview_UCM_308021_Article.jsp#.WyKre1VKiUk. Accessed June 14, 2018.
8. Centers for Disease Control and Prevention. The Paul Coverdell National Acute Stroke Registry. www.cdc.gov/DHDSP/stroke_registry.htm. Published March 13, 2008.
9. Reeves MJ, Parker C, Fonarow GC, Smith EE, Schwamm LH. Development of stroke performance measures: definitions, methods, and current measures. Stroke. 2010;41(7):1573-1578.
10. American College of Cardiology/American Heart Association Task Force on Performance Measures, Bonow RO, Masoudi FA, et al. ACC/AHA classification of care metrics: performance measures and quality metrics: a report of the American College of Cardiology/American Heart Association Task Force on performance measures. Circulation. 2008;118(24):2662-2666.
11. Centers for Medicare and Medicaid Services. Reporting Hospital Quality Data for Annual Payment Update https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HospitalQualityInits/downloads/HospitalFactSheetAP.pdf. Published November 2004. Accessed June 14, 2018.
12. Ballard DW, Kim AS, Huang J, et al; KP CREST Network Investigators. Implementation of computerized physician order entry is associated with increased thrombolytic administration for emergency department veterans with acute ischemic stroke. Ann Emerg Med. 2015;66(6):601-610.
Federal Health Care Data Trends: Gulf War & Post-9/11 Veterans
Currently, the largest growing percentage of veterans are those who served during the Gulf War and Post-9/11 era. Over the next few years, nearly every state in the US can expect growth in this veteran population greater than 20%. Although this group of 4.1 million veterans tend to use their VA health benefits less than do the veterans of previous eras, these veterans also exhibit some unique qualities not previously seen in VA patient populations. These veterans already have been identified to be at an increased risk of acquiring several diseases, which include arthritis, chronic fatigue syndrome, and sleep apnea. But perhaps the biggest shift, and the one that could require the most change in the way the Veterans Health Administration provides care, is along gender lines.
Click here to continue reading.
Currently, the largest growing percentage of veterans are those who served during the Gulf War and Post-9/11 era. Over the next few years, nearly every state in the US can expect growth in this veteran population greater than 20%. Although this group of 4.1 million veterans tend to use their VA health benefits less than do the veterans of previous eras, these veterans also exhibit some unique qualities not previously seen in VA patient populations. These veterans already have been identified to be at an increased risk of acquiring several diseases, which include arthritis, chronic fatigue syndrome, and sleep apnea. But perhaps the biggest shift, and the one that could require the most change in the way the Veterans Health Administration provides care, is along gender lines.
Click here to continue reading.
Currently, the largest growing percentage of veterans are those who served during the Gulf War and Post-9/11 era. Over the next few years, nearly every state in the US can expect growth in this veteran population greater than 20%. Although this group of 4.1 million veterans tend to use their VA health benefits less than do the veterans of previous eras, these veterans also exhibit some unique qualities not previously seen in VA patient populations. These veterans already have been identified to be at an increased risk of acquiring several diseases, which include arthritis, chronic fatigue syndrome, and sleep apnea. But perhaps the biggest shift, and the one that could require the most change in the way the Veterans Health Administration provides care, is along gender lines.
Click here to continue reading.
Inhibitor could be repurposed for MM
Tofacitinib, a pan-JAK inhibitor approved to treat rheumatoid arthritis, may advance as a potential treatment for multiple myeloma (MM) based on results from preclinical studies.
In these studies, tofacitinib was able to reverse proliferative effects in stromal-responsive human MM cell lines and reduce tumor growth in mouse models of MM.
Christine Lam, of University of California, San Francisco, and her colleagues conducted this research and reported the results in haematologica.
The researchers showed that, in co-cultures of MM cell lines and bone marrow stromal cells (BMSCs), tofacitinib inhibited the growth of MM cells in a dose-dependent manner.
RNA sequencing and phosphoproteonomics revealed an upregulation of 67 transcripts in MM cell lines co-cultured with BMSCs—most related to JAK-STAT and interleukin signaling.
Additional cell culture experiments showed that tofacitinib inhibited the downstream signaling molecule STAT3, which is responsible for proliferation through the JAK/STAT pathway.
The JAK1/2 inhibitor ruxolitinib did not replicate results seen with tofacitinib.
Further experiments showed that carfilzomib did not have synergistic effects with tofacitinib.
Venetoclax did demonstrate synergy with tofacitinib but only in MM cells cocultured with BMSCs, not in MM cells alone.
The researchers also tested tofacitinib in vivo. They injected mice with an MM cell line, and, after 2 weeks, mice were treated with tofacitinib for 4 weeks.
Mice treated with tofacitinib had lower tumor burden and a significant improvement in survival compared to untreated control mice.
Finally, the researchers tested tofacitinib in bone marrow mononuclear cells from patients. After stimulation with IL-6, the cells were exposed to tofacitinib.
The researchers observed “modest” viability against malignant plasma cells. They noted that because ex vivo MM plasma cells are minimally proliferative even with added cytokines or stromal stimulations, “these results may not fully reflect the potential therapeutic efficacy of tofacitinib in MM patients, where plasma cells are constantly proliferating within the [bone marrow].”
The researchers concluded that “tofacitinib is a promising agent to reverse the tumor-proliferative effects of the [bone marrow] microenvironment that can be rapidly repurposed to benefit MM patients.”
Tofacitinib, a pan-JAK inhibitor approved to treat rheumatoid arthritis, may advance as a potential treatment for multiple myeloma (MM) based on results from preclinical studies.
In these studies, tofacitinib was able to reverse proliferative effects in stromal-responsive human MM cell lines and reduce tumor growth in mouse models of MM.
Christine Lam, of University of California, San Francisco, and her colleagues conducted this research and reported the results in haematologica.
The researchers showed that, in co-cultures of MM cell lines and bone marrow stromal cells (BMSCs), tofacitinib inhibited the growth of MM cells in a dose-dependent manner.
RNA sequencing and phosphoproteonomics revealed an upregulation of 67 transcripts in MM cell lines co-cultured with BMSCs—most related to JAK-STAT and interleukin signaling.
Additional cell culture experiments showed that tofacitinib inhibited the downstream signaling molecule STAT3, which is responsible for proliferation through the JAK/STAT pathway.
The JAK1/2 inhibitor ruxolitinib did not replicate results seen with tofacitinib.
Further experiments showed that carfilzomib did not have synergistic effects with tofacitinib.
Venetoclax did demonstrate synergy with tofacitinib but only in MM cells cocultured with BMSCs, not in MM cells alone.
The researchers also tested tofacitinib in vivo. They injected mice with an MM cell line, and, after 2 weeks, mice were treated with tofacitinib for 4 weeks.
Mice treated with tofacitinib had lower tumor burden and a significant improvement in survival compared to untreated control mice.
Finally, the researchers tested tofacitinib in bone marrow mononuclear cells from patients. After stimulation with IL-6, the cells were exposed to tofacitinib.
The researchers observed “modest” viability against malignant plasma cells. They noted that because ex vivo MM plasma cells are minimally proliferative even with added cytokines or stromal stimulations, “these results may not fully reflect the potential therapeutic efficacy of tofacitinib in MM patients, where plasma cells are constantly proliferating within the [bone marrow].”
The researchers concluded that “tofacitinib is a promising agent to reverse the tumor-proliferative effects of the [bone marrow] microenvironment that can be rapidly repurposed to benefit MM patients.”
Tofacitinib, a pan-JAK inhibitor approved to treat rheumatoid arthritis, may advance as a potential treatment for multiple myeloma (MM) based on results from preclinical studies.
In these studies, tofacitinib was able to reverse proliferative effects in stromal-responsive human MM cell lines and reduce tumor growth in mouse models of MM.
Christine Lam, of University of California, San Francisco, and her colleagues conducted this research and reported the results in haematologica.
The researchers showed that, in co-cultures of MM cell lines and bone marrow stromal cells (BMSCs), tofacitinib inhibited the growth of MM cells in a dose-dependent manner.
RNA sequencing and phosphoproteonomics revealed an upregulation of 67 transcripts in MM cell lines co-cultured with BMSCs—most related to JAK-STAT and interleukin signaling.
Additional cell culture experiments showed that tofacitinib inhibited the downstream signaling molecule STAT3, which is responsible for proliferation through the JAK/STAT pathway.
The JAK1/2 inhibitor ruxolitinib did not replicate results seen with tofacitinib.
Further experiments showed that carfilzomib did not have synergistic effects with tofacitinib.
Venetoclax did demonstrate synergy with tofacitinib but only in MM cells cocultured with BMSCs, not in MM cells alone.
The researchers also tested tofacitinib in vivo. They injected mice with an MM cell line, and, after 2 weeks, mice were treated with tofacitinib for 4 weeks.
Mice treated with tofacitinib had lower tumor burden and a significant improvement in survival compared to untreated control mice.
Finally, the researchers tested tofacitinib in bone marrow mononuclear cells from patients. After stimulation with IL-6, the cells were exposed to tofacitinib.
The researchers observed “modest” viability against malignant plasma cells. They noted that because ex vivo MM plasma cells are minimally proliferative even with added cytokines or stromal stimulations, “these results may not fully reflect the potential therapeutic efficacy of tofacitinib in MM patients, where plasma cells are constantly proliferating within the [bone marrow].”
The researchers concluded that “tofacitinib is a promising agent to reverse the tumor-proliferative effects of the [bone marrow] microenvironment that can be rapidly repurposed to benefit MM patients.”
The Pop That Stopped the Soccer Game
ANSWER
The radiograph shows an avulsion fracture of the right iliac crest. While the patient does have a growth plate in this location, there is asymmetry between the right and left sides.
Pelvic avulsion fractures can be easy to overlook and are often misdiagnosed as strains. Providers must remember that the pelvis serves as an insertion site for multiple muscles; in both adolescent and adult patients, certain activities (eg, sprinting, jumping, kicking) can increase tension and result in a bone avulsion. Affected patients typically report a popping sensation, pain with range of motion, and point tenderness over the fracture.
Avulsion fractures can usually be identified on x-ray; CT and MRI are used only when definitive diagnosis is unclear. Treatment consists of conservative management—rest, protected weight bearing, and physical therapy. Surgery is typically reserved for those with > 2 cm displacement of the fracture fragment.
In athletes, a gradual return to sports is advised, with full participation at four to 12 weeks postinjury. Possible complications include recurrent symptoms, prolonged healing time, nonunion, malunion, or hip weakness.
This patient was placed on crutches with non-weight-bearing status for one week. She used OTC pain medication as needed. The patient completed a four-week course of physical therapy and returned to full weight-bearing status. After six weeks, the patient had returned to full activity with pain-free range of motion and full strength.
ANSWER
The radiograph shows an avulsion fracture of the right iliac crest. While the patient does have a growth plate in this location, there is asymmetry between the right and left sides.
Pelvic avulsion fractures can be easy to overlook and are often misdiagnosed as strains. Providers must remember that the pelvis serves as an insertion site for multiple muscles; in both adolescent and adult patients, certain activities (eg, sprinting, jumping, kicking) can increase tension and result in a bone avulsion. Affected patients typically report a popping sensation, pain with range of motion, and point tenderness over the fracture.
Avulsion fractures can usually be identified on x-ray; CT and MRI are used only when definitive diagnosis is unclear. Treatment consists of conservative management—rest, protected weight bearing, and physical therapy. Surgery is typically reserved for those with > 2 cm displacement of the fracture fragment.
In athletes, a gradual return to sports is advised, with full participation at four to 12 weeks postinjury. Possible complications include recurrent symptoms, prolonged healing time, nonunion, malunion, or hip weakness.
This patient was placed on crutches with non-weight-bearing status for one week. She used OTC pain medication as needed. The patient completed a four-week course of physical therapy and returned to full weight-bearing status. After six weeks, the patient had returned to full activity with pain-free range of motion and full strength.
ANSWER
The radiograph shows an avulsion fracture of the right iliac crest. While the patient does have a growth plate in this location, there is asymmetry between the right and left sides.
Pelvic avulsion fractures can be easy to overlook and are often misdiagnosed as strains. Providers must remember that the pelvis serves as an insertion site for multiple muscles; in both adolescent and adult patients, certain activities (eg, sprinting, jumping, kicking) can increase tension and result in a bone avulsion. Affected patients typically report a popping sensation, pain with range of motion, and point tenderness over the fracture.
Avulsion fractures can usually be identified on x-ray; CT and MRI are used only when definitive diagnosis is unclear. Treatment consists of conservative management—rest, protected weight bearing, and physical therapy. Surgery is typically reserved for those with > 2 cm displacement of the fracture fragment.
In athletes, a gradual return to sports is advised, with full participation at four to 12 weeks postinjury. Possible complications include recurrent symptoms, prolonged healing time, nonunion, malunion, or hip weakness.
This patient was placed on crutches with non-weight-bearing status for one week. She used OTC pain medication as needed. The patient completed a four-week course of physical therapy and returned to full weight-bearing status. After six weeks, the patient had returned to full activity with pain-free range of motion and full strength.
A 13-year-old girl presents with her mother for evaluation of right hip pain following a soccer game two days ago. The patient says she felt a “pop” in her right hip while running and kicking the ball. She was escorted off the field, unable to finish the game.
Since then, she has had pain over the right superior pelvic region. She rates the pain as a 1/10 at rest but 7/10 with ambulation. She is unwilling to bear weight secondary to discomfort and has been using crutches provided by her trainer. She has been using ice and ibuprofen without relief. Her medical history is unremarkable.
On physical exam, you note a well-developed, well-nourished female in no acute distress. No ecchymosis, erythema, or abrasions can be seen on skin exam. The patient has point tenderness over the right iliac crest. She has mild pain and weakness with hip flexion and significant pain with abduction. The extremity is neurovascularly intact.
A pelvic radiograph is obtained. What is your impression?
ESMO, ASCO seek improved cancer services
The European Society for Medical Oncology (ESMO) and the American Society of Clinical Oncology (ASCO) have called for renewed political commitment to improve cancer services and reduce cancer deaths.
ASCO and ESMO issued a joint statement in which they asked heads of state and health ministers to attend the United Nations Civil Society Hearing on Non-communicable Diseases (NCDs) in September and reconfirm their commitment to “pass legislation and invest in actions that will reduce the burden of NCDs, including cancer.”
Specifically, ESMO and ASCO said governments should:
- Implement the 2017 World Health Assembly Cancer Resolution
- Develop and strengthen educational programs that provide lifestyle recommendations to reduce cancer risk (eg, prevent tobacco use, encourage healthy weight control, etc.)
- Develop efficient and cost-effective primary prevention measures (eg, Helicobacter pylori eradication)
- Ensure timely access to screening, early stage diagnosis, and treatment for all stages of cancer
- Strengthen health systems so they can provide cancer services to all who need them
- Provide essential secondary healthcare services that ensure an adequate number of well-trained oncology professionals who have access to necessary resources
- Aim to reduce premature mortality by 25% by 2025 and by 33% by 2030 across all NCDs.
“Recent UN and WHO reports1,2,3,4 note that, unless countries significantly scale-up their actions and investments, they will not meet agreed targets to reduce deaths from non-communicable diseases,” said ESMO President Josep Tabernero, MD, PhD.
“We are concerned that governments may find it easier to achieve their targets by reducing deaths from only some NCDs, leaving cancer patients behind. We believe there are cost-effective ways to improve cancer care and stand ready to assist countries in doing this by providing our expertise in cancer management to support implementation of the 2017 World Health Assembly Cancer Resolution.”
“We urge member states to consider our joint call and amendments to strengthen the political declaration to be approved during the UN high-level meeting on 27 September and thus change the future outlook for cancer patients worldwide.”
1. United Nations Report by the Secretary General, Document A_72_662, 21 December 2017: http://www.who.int/ncds/governance/high-level-commission/A_72_662.pdf
2. World Health Assembly Report by the WHO Director General, Document WHA 71.2, 26 May 2018: http://apps.who.int/gb/ebwha/pdf_files/WHA71/A71_R2-en.pdf
3. WHO Independent High-Level Commission on NCDs Report, Time to Deliver, 1 June 2018: http://apps.who.int/iris/bitstream/handle/10665/272710/9789241514163-eng.pdf?ua=1
4. WHO Report Saving Lives, Spending Less, 21 May 2018: http://apps.who.int/iris/bitstream/handle/10665/272534/WHO-NMH-NVI-18.8-eng.pdf
The European Society for Medical Oncology (ESMO) and the American Society of Clinical Oncology (ASCO) have called for renewed political commitment to improve cancer services and reduce cancer deaths.
ASCO and ESMO issued a joint statement in which they asked heads of state and health ministers to attend the United Nations Civil Society Hearing on Non-communicable Diseases (NCDs) in September and reconfirm their commitment to “pass legislation and invest in actions that will reduce the burden of NCDs, including cancer.”
Specifically, ESMO and ASCO said governments should:
- Implement the 2017 World Health Assembly Cancer Resolution
- Develop and strengthen educational programs that provide lifestyle recommendations to reduce cancer risk (eg, prevent tobacco use, encourage healthy weight control, etc.)
- Develop efficient and cost-effective primary prevention measures (eg, Helicobacter pylori eradication)
- Ensure timely access to screening, early stage diagnosis, and treatment for all stages of cancer
- Strengthen health systems so they can provide cancer services to all who need them
- Provide essential secondary healthcare services that ensure an adequate number of well-trained oncology professionals who have access to necessary resources
- Aim to reduce premature mortality by 25% by 2025 and by 33% by 2030 across all NCDs.
“Recent UN and WHO reports1,2,3,4 note that, unless countries significantly scale-up their actions and investments, they will not meet agreed targets to reduce deaths from non-communicable diseases,” said ESMO President Josep Tabernero, MD, PhD.
“We are concerned that governments may find it easier to achieve their targets by reducing deaths from only some NCDs, leaving cancer patients behind. We believe there are cost-effective ways to improve cancer care and stand ready to assist countries in doing this by providing our expertise in cancer management to support implementation of the 2017 World Health Assembly Cancer Resolution.”
“We urge member states to consider our joint call and amendments to strengthen the political declaration to be approved during the UN high-level meeting on 27 September and thus change the future outlook for cancer patients worldwide.”
1. United Nations Report by the Secretary General, Document A_72_662, 21 December 2017: http://www.who.int/ncds/governance/high-level-commission/A_72_662.pdf
2. World Health Assembly Report by the WHO Director General, Document WHA 71.2, 26 May 2018: http://apps.who.int/gb/ebwha/pdf_files/WHA71/A71_R2-en.pdf
3. WHO Independent High-Level Commission on NCDs Report, Time to Deliver, 1 June 2018: http://apps.who.int/iris/bitstream/handle/10665/272710/9789241514163-eng.pdf?ua=1
4. WHO Report Saving Lives, Spending Less, 21 May 2018: http://apps.who.int/iris/bitstream/handle/10665/272534/WHO-NMH-NVI-18.8-eng.pdf
The European Society for Medical Oncology (ESMO) and the American Society of Clinical Oncology (ASCO) have called for renewed political commitment to improve cancer services and reduce cancer deaths.
ASCO and ESMO issued a joint statement in which they asked heads of state and health ministers to attend the United Nations Civil Society Hearing on Non-communicable Diseases (NCDs) in September and reconfirm their commitment to “pass legislation and invest in actions that will reduce the burden of NCDs, including cancer.”
Specifically, ESMO and ASCO said governments should:
- Implement the 2017 World Health Assembly Cancer Resolution
- Develop and strengthen educational programs that provide lifestyle recommendations to reduce cancer risk (eg, prevent tobacco use, encourage healthy weight control, etc.)
- Develop efficient and cost-effective primary prevention measures (eg, Helicobacter pylori eradication)
- Ensure timely access to screening, early stage diagnosis, and treatment for all stages of cancer
- Strengthen health systems so they can provide cancer services to all who need them
- Provide essential secondary healthcare services that ensure an adequate number of well-trained oncology professionals who have access to necessary resources
- Aim to reduce premature mortality by 25% by 2025 and by 33% by 2030 across all NCDs.
“Recent UN and WHO reports1,2,3,4 note that, unless countries significantly scale-up their actions and investments, they will not meet agreed targets to reduce deaths from non-communicable diseases,” said ESMO President Josep Tabernero, MD, PhD.
“We are concerned that governments may find it easier to achieve their targets by reducing deaths from only some NCDs, leaving cancer patients behind. We believe there are cost-effective ways to improve cancer care and stand ready to assist countries in doing this by providing our expertise in cancer management to support implementation of the 2017 World Health Assembly Cancer Resolution.”
“We urge member states to consider our joint call and amendments to strengthen the political declaration to be approved during the UN high-level meeting on 27 September and thus change the future outlook for cancer patients worldwide.”
1. United Nations Report by the Secretary General, Document A_72_662, 21 December 2017: http://www.who.int/ncds/governance/high-level-commission/A_72_662.pdf
2. World Health Assembly Report by the WHO Director General, Document WHA 71.2, 26 May 2018: http://apps.who.int/gb/ebwha/pdf_files/WHA71/A71_R2-en.pdf
3. WHO Independent High-Level Commission on NCDs Report, Time to Deliver, 1 June 2018: http://apps.who.int/iris/bitstream/handle/10665/272710/9789241514163-eng.pdf?ua=1
4. WHO Report Saving Lives, Spending Less, 21 May 2018: http://apps.who.int/iris/bitstream/handle/10665/272534/WHO-NMH-NVI-18.8-eng.pdf
FDA revises guidance on screening blood for Zika
The US Food and Drug Administration (FDA) has released a revised guidance on testing donated blood and blood components for Zika virus.
The revised guidance states that it is no longer necessary to screen every donation individually.
Pooled donations can be tested for Zika virus in most cases, although, in areas where there is an increased risk of mosquito-borne transmission of Zika, donations should be tested individually.
The FDA said the revised guidance is a result of careful consideration of all available scientific evidence, including consultation with other public health agencies, and following the recommendations of the December 2017 meeting of the Blood Products Advisory Committee.
“When Zika virus first emerged, the unknown course of the epidemic and the observed severe effects from the disease indicated that individual donor testing was needed to ensure the continued safety of the blood supply,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.
“Now, given the significant decrease in cases of Zika virus infection in the US and its territories, we are moving away from testing each individual donation to testing pooled donations. This is usually more cost-effective and less burdensome for blood establishments. However, the FDA will continue to monitor the situation closely, and as appropriate, reconsider what measures are needed to maintain the safety of the blood supply.”
The FDA’s revised guidance replaces the August 2016 guidance, which recommended universal nucleic acid testing of individual units of blood donated in US states and territories.
The revised guidance explains that, to comply with applicable testing regulations, blood establishments must continue to test all donated whole blood and blood components for Zika virus using a nucleic acid test.
However, in many cases, pooled testing of donations using an FDA-licensed screening test is a sufficient method for complying with these regulations. If there is an increased risk of local mosquito-borne transmission of Zika virus in a specific area, donations should be tested individually.
As an alternative to pooled or individual testing, blood establishments can use an FDA-approved pathogen-reduction device for plasma and certain platelet products.
The FDA said these recommendations will continue to ensure the safety of the US blood supply by reducing the risk of Zika virus transmission while also reducing the burden of testing for blood establishments.
The US Food and Drug Administration (FDA) has released a revised guidance on testing donated blood and blood components for Zika virus.
The revised guidance states that it is no longer necessary to screen every donation individually.
Pooled donations can be tested for Zika virus in most cases, although, in areas where there is an increased risk of mosquito-borne transmission of Zika, donations should be tested individually.
The FDA said the revised guidance is a result of careful consideration of all available scientific evidence, including consultation with other public health agencies, and following the recommendations of the December 2017 meeting of the Blood Products Advisory Committee.
“When Zika virus first emerged, the unknown course of the epidemic and the observed severe effects from the disease indicated that individual donor testing was needed to ensure the continued safety of the blood supply,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.
“Now, given the significant decrease in cases of Zika virus infection in the US and its territories, we are moving away from testing each individual donation to testing pooled donations. This is usually more cost-effective and less burdensome for blood establishments. However, the FDA will continue to monitor the situation closely, and as appropriate, reconsider what measures are needed to maintain the safety of the blood supply.”
The FDA’s revised guidance replaces the August 2016 guidance, which recommended universal nucleic acid testing of individual units of blood donated in US states and territories.
The revised guidance explains that, to comply with applicable testing regulations, blood establishments must continue to test all donated whole blood and blood components for Zika virus using a nucleic acid test.
However, in many cases, pooled testing of donations using an FDA-licensed screening test is a sufficient method for complying with these regulations. If there is an increased risk of local mosquito-borne transmission of Zika virus in a specific area, donations should be tested individually.
As an alternative to pooled or individual testing, blood establishments can use an FDA-approved pathogen-reduction device for plasma and certain platelet products.
The FDA said these recommendations will continue to ensure the safety of the US blood supply by reducing the risk of Zika virus transmission while also reducing the burden of testing for blood establishments.
The US Food and Drug Administration (FDA) has released a revised guidance on testing donated blood and blood components for Zika virus.
The revised guidance states that it is no longer necessary to screen every donation individually.
Pooled donations can be tested for Zika virus in most cases, although, in areas where there is an increased risk of mosquito-borne transmission of Zika, donations should be tested individually.
The FDA said the revised guidance is a result of careful consideration of all available scientific evidence, including consultation with other public health agencies, and following the recommendations of the December 2017 meeting of the Blood Products Advisory Committee.
“When Zika virus first emerged, the unknown course of the epidemic and the observed severe effects from the disease indicated that individual donor testing was needed to ensure the continued safety of the blood supply,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.
“Now, given the significant decrease in cases of Zika virus infection in the US and its territories, we are moving away from testing each individual donation to testing pooled donations. This is usually more cost-effective and less burdensome for blood establishments. However, the FDA will continue to monitor the situation closely, and as appropriate, reconsider what measures are needed to maintain the safety of the blood supply.”
The FDA’s revised guidance replaces the August 2016 guidance, which recommended universal nucleic acid testing of individual units of blood donated in US states and territories.
The revised guidance explains that, to comply with applicable testing regulations, blood establishments must continue to test all donated whole blood and blood components for Zika virus using a nucleic acid test.
However, in many cases, pooled testing of donations using an FDA-licensed screening test is a sufficient method for complying with these regulations. If there is an increased risk of local mosquito-borne transmission of Zika virus in a specific area, donations should be tested individually.
As an alternative to pooled or individual testing, blood establishments can use an FDA-approved pathogen-reduction device for plasma and certain platelet products.
The FDA said these recommendations will continue to ensure the safety of the US blood supply by reducing the risk of Zika virus transmission while also reducing the burden of testing for blood establishments.
GOP Doctors Caucus seeks lower MIPS threshold
The House GOP Doctors Caucus is pushing officials at the Centers for Medicare & Medicaid to lower the exclusion threshold for participation in the Merit-Based Incentive Payment System (MIPS).
In a letter to CMS Administrator Seema Verma, the lawmakers noted that about 60% of health care providers are excluded from MIPS – one track of the agency’s Quality Payment Program – mostly because of the high participation threshold set by the agency.
Since the program provides incentive payments to doctors by shifting Medicare Part B payments, the low participation is also lowering the payments available for high-level performance.
“The most notable ramification of the current threshold has been lower maximum positive updates on how MIPS ultimately adjusts Part B payments,” the lawmakers wrote. “For example, high performers are estimated to receive an aggregate payment adjustment in 2019 of 1.1% – based on their 2017 performance – even though adjustments of up to 4% are authorized.”
This payment trend “fails to incentivize meaningful participation in MIPS,” they wrote.
The current MIPS threshold excludes any physician or practice that generates $90,000 or less in Part B billing or sees 200 or fewer Medicare patients. The agency had initially set the threshold lower, at $30,000 or less in billing or 100 patients but created a larger exemption based on feedback from many physician groups.
The five members of the House GOP Doctors Caucus who signed on to the letter are Phil Roe (Tenn.), Andy Harris (Md.), Earl “Buddy” Carter (Ga.), Larry Bucshon (Ind.), and Scott DesJarlais (Tenn.).
The House GOP Doctors Caucus is pushing officials at the Centers for Medicare & Medicaid to lower the exclusion threshold for participation in the Merit-Based Incentive Payment System (MIPS).
In a letter to CMS Administrator Seema Verma, the lawmakers noted that about 60% of health care providers are excluded from MIPS – one track of the agency’s Quality Payment Program – mostly because of the high participation threshold set by the agency.
Since the program provides incentive payments to doctors by shifting Medicare Part B payments, the low participation is also lowering the payments available for high-level performance.
“The most notable ramification of the current threshold has been lower maximum positive updates on how MIPS ultimately adjusts Part B payments,” the lawmakers wrote. “For example, high performers are estimated to receive an aggregate payment adjustment in 2019 of 1.1% – based on their 2017 performance – even though adjustments of up to 4% are authorized.”
This payment trend “fails to incentivize meaningful participation in MIPS,” they wrote.
The current MIPS threshold excludes any physician or practice that generates $90,000 or less in Part B billing or sees 200 or fewer Medicare patients. The agency had initially set the threshold lower, at $30,000 or less in billing or 100 patients but created a larger exemption based on feedback from many physician groups.
The five members of the House GOP Doctors Caucus who signed on to the letter are Phil Roe (Tenn.), Andy Harris (Md.), Earl “Buddy” Carter (Ga.), Larry Bucshon (Ind.), and Scott DesJarlais (Tenn.).
The House GOP Doctors Caucus is pushing officials at the Centers for Medicare & Medicaid to lower the exclusion threshold for participation in the Merit-Based Incentive Payment System (MIPS).
In a letter to CMS Administrator Seema Verma, the lawmakers noted that about 60% of health care providers are excluded from MIPS – one track of the agency’s Quality Payment Program – mostly because of the high participation threshold set by the agency.
Since the program provides incentive payments to doctors by shifting Medicare Part B payments, the low participation is also lowering the payments available for high-level performance.
“The most notable ramification of the current threshold has been lower maximum positive updates on how MIPS ultimately adjusts Part B payments,” the lawmakers wrote. “For example, high performers are estimated to receive an aggregate payment adjustment in 2019 of 1.1% – based on their 2017 performance – even though adjustments of up to 4% are authorized.”
This payment trend “fails to incentivize meaningful participation in MIPS,” they wrote.
The current MIPS threshold excludes any physician or practice that generates $90,000 or less in Part B billing or sees 200 or fewer Medicare patients. The agency had initially set the threshold lower, at $30,000 or less in billing or 100 patients but created a larger exemption based on feedback from many physician groups.
The five members of the House GOP Doctors Caucus who signed on to the letter are Phil Roe (Tenn.), Andy Harris (Md.), Earl “Buddy” Carter (Ga.), Larry Bucshon (Ind.), and Scott DesJarlais (Tenn.).
For some opioid overdose survivors, stigma from clinicians hinders recovery
SAN DIEGO – After an opioid-related overdose, intentions to reduce opioid use or injection are often complicated by unmanaged withdrawal symptoms and perceptions of disrespect from first responders and/or hospital staff, results from a small, exploratory study suggest.
“The opportunity for getting someone out of an overdose experience and into harm reduction, medication-assisted treatment, whatever it may be, is great,” lead study author Luther C. Elliott, PhD, said in an interview at the annual meeting of the College on Problems of Drug Dependence. “But the stigmatizing experiences of survivors tend to lead them in a beeline out of the emergency department.”
In an effort to better understand the impacts of nonfatal overdose on subsequent substance abuse patterns and overdose risk behaviors, Alex S. Bennett, PhD, Dr. Elliott, and Brett Wolfson-Stofko, PhD, interviewed 20 recent overdose survivors about their experiences. All study participants had been administered naloxone by a professional first responder and taken to an emergency department via ambulance. Next, the researchers juxtaposed their narratives with perspectives from nine emergency medical technicians (EMTs), six emergency department staff members, and six medical staff members.
“Each stakeholder was asked about their experiences with opioid-involved overdose and about the potential for staging effective interventions with persons who have been recently reversed,” explained Dr. Elliott, a medical anthropologist at the New York City–based National Development and Research Institutes.
The researchers found that 67% of EMT/emergency medical services (EMS) personnel had a history of discussing opioid-related overdose or need for treatment, while 57% had self-reported fatigue or burnout with opioid-related overdose patients. For example, one EMT/EMS study participant described responding to overdose calls as taxing. “It takes away from what I would call real patients. …When I hear you took this drug by yourself and I have to go save [you], how is that fair?”
All nine emergency medicine physicians queried had a history of intervening and self-reported fatigue or burnout with opioid-related overdose patients. One physician response was as follows: “If I’m going to see the same person over and over again, I’ve tried my best to help you and you go back to the same thing over and over again, at some point, I’m not going to have any compassion.”
Of the 20 survivors, 30% indicated no reported change in their behavioral disposition after the overdose, 10% reported delayed change, and 60% reported immediate change. Barriers to change, expressed by some of the survivors, included receiving higher doses of naloxone than necessary to reverse an opioid-related overdose, and perceived disrespect from emergency department staff. For example, one survivor contended that hospital staff “left me in the hallway. I kept asking for water and they’re like, ‘We have none.’ They brought me some ice chips finally to shut me up, because I kept trying to walk out.”
Dr. Elliott said he was surprised to learn how much EMS staff and emergency medicine physicians attempted informal interventions by just talking with survivors. “They’ve used a combination of shaming techniques, like, ‘Do you realize you almost died? You’ve got to stop using drugs.’ The stigmatizing attitudes combined with the willingness and the desire to intervene were most surprising to me.
In their abstract, he and his associates wrote that providing stakeholders “with even a brief general introduction to psychosocial interventions and sample scripts of supportive, motivational, and nonstigmatizing conversations between caregivers and the people experiencing opioid dependency may represent a positive advance in this direction.”
The study was funded by the National Institute on Drug Abuse. The authors reported having no financial disclosures and said the study content is solely their responsibility – and does not necessarily represent the official views of the National Institutes of Health.
SAN DIEGO – After an opioid-related overdose, intentions to reduce opioid use or injection are often complicated by unmanaged withdrawal symptoms and perceptions of disrespect from first responders and/or hospital staff, results from a small, exploratory study suggest.
“The opportunity for getting someone out of an overdose experience and into harm reduction, medication-assisted treatment, whatever it may be, is great,” lead study author Luther C. Elliott, PhD, said in an interview at the annual meeting of the College on Problems of Drug Dependence. “But the stigmatizing experiences of survivors tend to lead them in a beeline out of the emergency department.”
In an effort to better understand the impacts of nonfatal overdose on subsequent substance abuse patterns and overdose risk behaviors, Alex S. Bennett, PhD, Dr. Elliott, and Brett Wolfson-Stofko, PhD, interviewed 20 recent overdose survivors about their experiences. All study participants had been administered naloxone by a professional first responder and taken to an emergency department via ambulance. Next, the researchers juxtaposed their narratives with perspectives from nine emergency medical technicians (EMTs), six emergency department staff members, and six medical staff members.
“Each stakeholder was asked about their experiences with opioid-involved overdose and about the potential for staging effective interventions with persons who have been recently reversed,” explained Dr. Elliott, a medical anthropologist at the New York City–based National Development and Research Institutes.
The researchers found that 67% of EMT/emergency medical services (EMS) personnel had a history of discussing opioid-related overdose or need for treatment, while 57% had self-reported fatigue or burnout with opioid-related overdose patients. For example, one EMT/EMS study participant described responding to overdose calls as taxing. “It takes away from what I would call real patients. …When I hear you took this drug by yourself and I have to go save [you], how is that fair?”
All nine emergency medicine physicians queried had a history of intervening and self-reported fatigue or burnout with opioid-related overdose patients. One physician response was as follows: “If I’m going to see the same person over and over again, I’ve tried my best to help you and you go back to the same thing over and over again, at some point, I’m not going to have any compassion.”
Of the 20 survivors, 30% indicated no reported change in their behavioral disposition after the overdose, 10% reported delayed change, and 60% reported immediate change. Barriers to change, expressed by some of the survivors, included receiving higher doses of naloxone than necessary to reverse an opioid-related overdose, and perceived disrespect from emergency department staff. For example, one survivor contended that hospital staff “left me in the hallway. I kept asking for water and they’re like, ‘We have none.’ They brought me some ice chips finally to shut me up, because I kept trying to walk out.”
Dr. Elliott said he was surprised to learn how much EMS staff and emergency medicine physicians attempted informal interventions by just talking with survivors. “They’ve used a combination of shaming techniques, like, ‘Do you realize you almost died? You’ve got to stop using drugs.’ The stigmatizing attitudes combined with the willingness and the desire to intervene were most surprising to me.
In their abstract, he and his associates wrote that providing stakeholders “with even a brief general introduction to psychosocial interventions and sample scripts of supportive, motivational, and nonstigmatizing conversations between caregivers and the people experiencing opioid dependency may represent a positive advance in this direction.”
The study was funded by the National Institute on Drug Abuse. The authors reported having no financial disclosures and said the study content is solely their responsibility – and does not necessarily represent the official views of the National Institutes of Health.
SAN DIEGO – After an opioid-related overdose, intentions to reduce opioid use or injection are often complicated by unmanaged withdrawal symptoms and perceptions of disrespect from first responders and/or hospital staff, results from a small, exploratory study suggest.
“The opportunity for getting someone out of an overdose experience and into harm reduction, medication-assisted treatment, whatever it may be, is great,” lead study author Luther C. Elliott, PhD, said in an interview at the annual meeting of the College on Problems of Drug Dependence. “But the stigmatizing experiences of survivors tend to lead them in a beeline out of the emergency department.”
In an effort to better understand the impacts of nonfatal overdose on subsequent substance abuse patterns and overdose risk behaviors, Alex S. Bennett, PhD, Dr. Elliott, and Brett Wolfson-Stofko, PhD, interviewed 20 recent overdose survivors about their experiences. All study participants had been administered naloxone by a professional first responder and taken to an emergency department via ambulance. Next, the researchers juxtaposed their narratives with perspectives from nine emergency medical technicians (EMTs), six emergency department staff members, and six medical staff members.
“Each stakeholder was asked about their experiences with opioid-involved overdose and about the potential for staging effective interventions with persons who have been recently reversed,” explained Dr. Elliott, a medical anthropologist at the New York City–based National Development and Research Institutes.
The researchers found that 67% of EMT/emergency medical services (EMS) personnel had a history of discussing opioid-related overdose or need for treatment, while 57% had self-reported fatigue or burnout with opioid-related overdose patients. For example, one EMT/EMS study participant described responding to overdose calls as taxing. “It takes away from what I would call real patients. …When I hear you took this drug by yourself and I have to go save [you], how is that fair?”
All nine emergency medicine physicians queried had a history of intervening and self-reported fatigue or burnout with opioid-related overdose patients. One physician response was as follows: “If I’m going to see the same person over and over again, I’ve tried my best to help you and you go back to the same thing over and over again, at some point, I’m not going to have any compassion.”
Of the 20 survivors, 30% indicated no reported change in their behavioral disposition after the overdose, 10% reported delayed change, and 60% reported immediate change. Barriers to change, expressed by some of the survivors, included receiving higher doses of naloxone than necessary to reverse an opioid-related overdose, and perceived disrespect from emergency department staff. For example, one survivor contended that hospital staff “left me in the hallway. I kept asking for water and they’re like, ‘We have none.’ They brought me some ice chips finally to shut me up, because I kept trying to walk out.”
Dr. Elliott said he was surprised to learn how much EMS staff and emergency medicine physicians attempted informal interventions by just talking with survivors. “They’ve used a combination of shaming techniques, like, ‘Do you realize you almost died? You’ve got to stop using drugs.’ The stigmatizing attitudes combined with the willingness and the desire to intervene were most surprising to me.
In their abstract, he and his associates wrote that providing stakeholders “with even a brief general introduction to psychosocial interventions and sample scripts of supportive, motivational, and nonstigmatizing conversations between caregivers and the people experiencing opioid dependency may represent a positive advance in this direction.”
The study was funded by the National Institute on Drug Abuse. The authors reported having no financial disclosures and said the study content is solely their responsibility – and does not necessarily represent the official views of the National Institutes of Health.
AT CPDD 2018
Key clinical point: The majority of emergency medical services personnel and emergency department physicians indicated a history of attempting to discuss positive health change with overdose survivors.
Major finding: Of the 20 survivors interviewed, 30% indicated no reported change in their behavioral disposition after the overdose, 10% reported delayed change, and 60% reported immediate change.
Study details: An exploratory study of 20 opioid overdose survivors who were interviewed about their experiences.
Disclosures: The study was funded by the National Institute on Drug Abuse. The authors reported having no financial disclosures.
Damned documentation
Sorry, but I can’t help you. What I can do is tell you you’re not alone. Datamania is now an endemic malady. Everybody has it and everybody’s doing it, even some you’d never imagine. If misery loves company, you should soon be head over heels.
1. Tiers for Tots
“What are the parents like?” I ask.
“They’re great!” Tracy says. “They want their kids to be creative and play.”
She frowns. “But my boss insists I give him data.”
“Data? What data?”
“Studies show that letter recognition in kindergarten correlates with reading ability in third grade,” she says. “So I have to test the kids and provide him with the data.”
“And what if the kids flub letter recognition?”
Tracy’s smile is now rueful. “Then they might need a Tier 2 intervention.”
“Good grief! What is a Tier 2 intervention?”
“It’s time consuming,” she says. “It takes a lot of one-on-one work, me and the kid.”
Less play all around, I guess. But documentation must be done, and data delivered. By the kindergarten teacher!
2. Filing for firefighters
Bruce has been a firefighter for 30 years, and it’s starting to wear him down. The physical exertion? The stress? Nah.
“The paperwork is driving me crazy,” he says.
“What paperwork?”
“In between calls, we spend hours filling out forms,” he says.
“Which forms?”
“At the scene, you go to work on the fire and help people get to safety. Then you see how they’re doing, and refer the ones who need it for medical help.
“Used to be,” says Bruce, “that you’d eyeball someone, ask them how they felt and if they needed to go to the hospital. If they said they were OK, they were good to leave.”
“And now?”
“Now we have to cover ourselves. We need to document how they look, what they say, what we asked them, what they answered. They have to sign a release that we asked them what we needed to ask and they answered what we needed to hear, that they said they were OK and didn’t need to go to the ER and signed off on it. Takes a lot of time.”
And paper. Maybe little kids who used to dream of being firefighters will start to dream that they’ll be file clerks with big red hats.
3. Your personal banker doesn’t know you!
Marina looks frazzled. “Stress at work,” she says. “It gets worse all the time.”
I know Marina works at a community bank. “What’s the problem?” I ask. “More restrictions on lending?”
“Oh sure,” she says, “but that’s an old story. Now there are new regulations to prevent money laundering. We have to know the identity of anybody who makes a deposit.”
“Sounds reasonable.”
“In principle sure,” she says. “But in practice what happens is this: Somebody wants to make any change – to add a relative, upgrade to a newer checking account. Even if they’ve been our depositors for 20 years, we have to ask them to produce all kinds of personal information for us to show regulators if they ask if we know people we’ve known forever.”
“Do the regulators ever ask?”
“Of course not,” says Marina. “But we have to fill out the forms, which take all day.”
It’s everywhere, folks. Bureaucratization is pervasive. No one can escape. Where is Franz Kafka now that we need him?
We in medicine know this all too well, of course. Perhaps the leading cause of physician retirement is introducing EHR into the institutions they work at.
There are, of course, always reasons and justifications for bureaucratic rules. You know them all, and it doesn’t matter. Fish gotta swim and clerks gotta file. Besides, it is now an article of faith that from large data sets shall go forth great wisdom. In precision medicine. Also, in kindergarten.
Sorry, but I have to go. I’m doing my charts, and there are templates to paste and boilers to plate.
As the apocryphal cardiologist may have said, “Hey, things could be worse. I could be younger.”
Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at [email protected].
Sorry, but I can’t help you. What I can do is tell you you’re not alone. Datamania is now an endemic malady. Everybody has it and everybody’s doing it, even some you’d never imagine. If misery loves company, you should soon be head over heels.
1. Tiers for Tots
“What are the parents like?” I ask.
“They’re great!” Tracy says. “They want their kids to be creative and play.”
She frowns. “But my boss insists I give him data.”
“Data? What data?”
“Studies show that letter recognition in kindergarten correlates with reading ability in third grade,” she says. “So I have to test the kids and provide him with the data.”
“And what if the kids flub letter recognition?”
Tracy’s smile is now rueful. “Then they might need a Tier 2 intervention.”
“Good grief! What is a Tier 2 intervention?”
“It’s time consuming,” she says. “It takes a lot of one-on-one work, me and the kid.”
Less play all around, I guess. But documentation must be done, and data delivered. By the kindergarten teacher!
2. Filing for firefighters
Bruce has been a firefighter for 30 years, and it’s starting to wear him down. The physical exertion? The stress? Nah.
“The paperwork is driving me crazy,” he says.
“What paperwork?”
“In between calls, we spend hours filling out forms,” he says.
“Which forms?”
“At the scene, you go to work on the fire and help people get to safety. Then you see how they’re doing, and refer the ones who need it for medical help.
“Used to be,” says Bruce, “that you’d eyeball someone, ask them how they felt and if they needed to go to the hospital. If they said they were OK, they were good to leave.”
“And now?”
“Now we have to cover ourselves. We need to document how they look, what they say, what we asked them, what they answered. They have to sign a release that we asked them what we needed to ask and they answered what we needed to hear, that they said they were OK and didn’t need to go to the ER and signed off on it. Takes a lot of time.”
And paper. Maybe little kids who used to dream of being firefighters will start to dream that they’ll be file clerks with big red hats.
3. Your personal banker doesn’t know you!
Marina looks frazzled. “Stress at work,” she says. “It gets worse all the time.”
I know Marina works at a community bank. “What’s the problem?” I ask. “More restrictions on lending?”
“Oh sure,” she says, “but that’s an old story. Now there are new regulations to prevent money laundering. We have to know the identity of anybody who makes a deposit.”
“Sounds reasonable.”
“In principle sure,” she says. “But in practice what happens is this: Somebody wants to make any change – to add a relative, upgrade to a newer checking account. Even if they’ve been our depositors for 20 years, we have to ask them to produce all kinds of personal information for us to show regulators if they ask if we know people we’ve known forever.”
“Do the regulators ever ask?”
“Of course not,” says Marina. “But we have to fill out the forms, which take all day.”
It’s everywhere, folks. Bureaucratization is pervasive. No one can escape. Where is Franz Kafka now that we need him?
We in medicine know this all too well, of course. Perhaps the leading cause of physician retirement is introducing EHR into the institutions they work at.
There are, of course, always reasons and justifications for bureaucratic rules. You know them all, and it doesn’t matter. Fish gotta swim and clerks gotta file. Besides, it is now an article of faith that from large data sets shall go forth great wisdom. In precision medicine. Also, in kindergarten.
Sorry, but I have to go. I’m doing my charts, and there are templates to paste and boilers to plate.
As the apocryphal cardiologist may have said, “Hey, things could be worse. I could be younger.”
Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at [email protected].
Sorry, but I can’t help you. What I can do is tell you you’re not alone. Datamania is now an endemic malady. Everybody has it and everybody’s doing it, even some you’d never imagine. If misery loves company, you should soon be head over heels.
1. Tiers for Tots
“What are the parents like?” I ask.
“They’re great!” Tracy says. “They want their kids to be creative and play.”
She frowns. “But my boss insists I give him data.”
“Data? What data?”
“Studies show that letter recognition in kindergarten correlates with reading ability in third grade,” she says. “So I have to test the kids and provide him with the data.”
“And what if the kids flub letter recognition?”
Tracy’s smile is now rueful. “Then they might need a Tier 2 intervention.”
“Good grief! What is a Tier 2 intervention?”
“It’s time consuming,” she says. “It takes a lot of one-on-one work, me and the kid.”
Less play all around, I guess. But documentation must be done, and data delivered. By the kindergarten teacher!
2. Filing for firefighters
Bruce has been a firefighter for 30 years, and it’s starting to wear him down. The physical exertion? The stress? Nah.
“The paperwork is driving me crazy,” he says.
“What paperwork?”
“In between calls, we spend hours filling out forms,” he says.
“Which forms?”
“At the scene, you go to work on the fire and help people get to safety. Then you see how they’re doing, and refer the ones who need it for medical help.
“Used to be,” says Bruce, “that you’d eyeball someone, ask them how they felt and if they needed to go to the hospital. If they said they were OK, they were good to leave.”
“And now?”
“Now we have to cover ourselves. We need to document how they look, what they say, what we asked them, what they answered. They have to sign a release that we asked them what we needed to ask and they answered what we needed to hear, that they said they were OK and didn’t need to go to the ER and signed off on it. Takes a lot of time.”
And paper. Maybe little kids who used to dream of being firefighters will start to dream that they’ll be file clerks with big red hats.
3. Your personal banker doesn’t know you!
Marina looks frazzled. “Stress at work,” she says. “It gets worse all the time.”
I know Marina works at a community bank. “What’s the problem?” I ask. “More restrictions on lending?”
“Oh sure,” she says, “but that’s an old story. Now there are new regulations to prevent money laundering. We have to know the identity of anybody who makes a deposit.”
“Sounds reasonable.”
“In principle sure,” she says. “But in practice what happens is this: Somebody wants to make any change – to add a relative, upgrade to a newer checking account. Even if they’ve been our depositors for 20 years, we have to ask them to produce all kinds of personal information for us to show regulators if they ask if we know people we’ve known forever.”
“Do the regulators ever ask?”
“Of course not,” says Marina. “But we have to fill out the forms, which take all day.”
It’s everywhere, folks. Bureaucratization is pervasive. No one can escape. Where is Franz Kafka now that we need him?
We in medicine know this all too well, of course. Perhaps the leading cause of physician retirement is introducing EHR into the institutions they work at.
There are, of course, always reasons and justifications for bureaucratic rules. You know them all, and it doesn’t matter. Fish gotta swim and clerks gotta file. Besides, it is now an article of faith that from large data sets shall go forth great wisdom. In precision medicine. Also, in kindergarten.
Sorry, but I have to go. I’m doing my charts, and there are templates to paste and boilers to plate.
As the apocryphal cardiologist may have said, “Hey, things could be worse. I could be younger.”
Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. His second book, “Act Like a Doctor, Think Like a Patient,” is available at amazon.com and barnesandnoble.com. Write to him at [email protected].