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The Fairy Meadow community will soon receive its own ambulance station under the NSW Government’s $232 million Rural Ambulance Infrastructure Reconfiguration (RAIR) program.Minister for Health Brad Hazzard said Fairy Meadow was identified as the ideal location to base a new station to provide the best ambulance coverage across the Illawarra region, now and in the future.“This is a first for Fairy Meadow, providing paramedics with a modern facility with state-of-the-art equipment to help them carry out their vital job of saving lives in the local Illawarra communities,” canada levitra online Mr Hazzard said.“The next step will be choosing the best site in Fairy Meadow to build the http://markolewis.com/purchase-levitra/ ambulance station. To do this we have expert help from tried and tested international software which maps Triple Zero calls.”NSW Ambulance Assistant Commissioner Clare Lorenzen said the announcement was another welcome NSW Government initiative for regional and rural communities.“Operating from a new base in Fairy Meadow, our local paramedics will be well positioned to continue to provide the best possible high-quality emergency medical care to residents of local communities,” Ms Lorenzen said.“The additional ambulance service in Fairy Meadow will support the Bulli and Wollongong ambulance stations to strengthen the coverage of the Illawarra region.” canada levitra online The RAIR program is the single largest investment in regional NSW Ambulance’s 126-year history, with 24 new or upgraded ambulance stations already delivered or under construction as part of the $132 million Stage 1 program. The new station for the Illawarra community is part of the NSW Government’s additional $100 million investment in Stage 2 of the RAIR program.In 2020-21, the NSW canada levitra online Government is investing more than $1 billion in services and capital works for NSW Ambulance.This includes $27 million of funding for 180 new NSW Ambulance staff across NSW, as part of the third tranche of the June 2018 commitment to recruit 750 additional paramedic and control centre staff over four years..

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COMING IN April 2021 - In the NYS Budget enacted in April 2020, http://brillanteinteriors.com/viagra-online-canada the pharmacy benefit was "carved out" of "mainstream" Medicaid managed care plans what is levitra used for. That means that members of managed care plans will access their drugs outside their plan, unlike the rest of their medical care, which is accessed from in-network providers. How Prescription Drugs are Obtained through Managed Care plans No - Until April 2020 HOW DO MANAGED CARE PLANS DEFINE THE PHARMACY BENEFIT FOR CONSUMERS?. The Medicaid pharmacy benefit includes all FDA approved prescription drugs, as well as what is levitra used for some over-the-counter drugs and medical supplies.

Under Medicaid managed care. Plan formularies will be comparable to but not the same as the Medicaid formulary. Managed care plans are required to have drug formularies that are “comparable” to the Medicaid what is levitra used for fee for service formulary. Plan formularies do not have to include all drugs covered listed on the fee for service formulary, but they must include generic or therapeutic equivalents of all Medicaid covered drugs.

The Pharmacy Benefit will vary by plan. Each plan will have its own formulary and drug coverage policies like prior authorization and what is levitra used for step therapy. Pharmacy networks can also differ from plan to plan. Prescriber Prevails applies in certain drug classes.

Prescriber what is levitra used for prevails applys to medically necessary precription drugs in the following classes. atypical antipsychotics, anti-depressants, anti-retrovirals, anti-rejection, seizure, epilepsy, endocrine, hemotologic and immunologic therapeutics. Prescribers will need to demonstrate reasonable profession judgment and supply plans witht requested information and/or clinical documentation. Pharmacy Benefit Information Website -- http://mmcdruginformation.nysdoh.suny.edu/-- This website provides very helpful what is levitra used for information on a plan by plan basis regarding pharmacy networks and drug formularies.

The Department of Health plans to build capacity for interactive searches allowing for comparison of coverage across plans in the near future. Standardized Prior Autorization (PA) Form -- The Department of Health worked with managed care plans, provider organizations and other state agencies to develop a standard prior authorization form for the pharmacy benefit in Medicaid managed care. The form will be posted on what is levitra used for the Pharmacy Information Website in July of 2013. Mail Order Drugs -- Medicaid managed care members can obtain mail order/specialty drugs at any retail network pharmacy, as long as that retail network pharmacy agrees to a price that is comparable to the mail order/specialty pharmacy price.

CAN CONSUMERS SWITCH PLANS IN ORDER TO GAIN ACCESS TO DRUGS?. Changing plans is often an what is levitra used for effective strategy for consumers eligible for both Medicaid and Medicare (dual eligibles) who receive their pharmacy service through Medicare Part D, because dual eligibles are allowed to switch plans at any time. Medicaid consumers will have this option only in the limited circumstances during the first year of enrollment in managed care. Medicaid managed care enrollees can only leave and join another plan within the first 90 days of joining a health plan.

After the 90 days has expired, enrollees are “locked in” to the what is levitra used for plan for the rest of the year. Consumers can switch plans during the “lock in” period only for good cause. The pharmacy benefit changes are not considered good cause. After the what is levitra used for first 12 months of enrollment, Medicaid managed care enrollees can switch plans at any time.

STEPS CONSUMERS CAN TAKE WHEN A MANAGED CARE PLAM DENIES ACCESS TO A NECESSARY DRUG As a first step, consumers should try to work with their providers to satisfy plan requirements for prior authorization or step therapy or any other utilization control requirements. If the plan still denies access, consumers can pursue review processes specific to managed care while at the same time pursuing a fair hearing. All plans are required to maintain an internal and external what is levitra used for review process for complaints and appeals of service denials. Some plans may develop special procedures for drug denials.

Information on these procedures should be provided in member handbooks. Beginning April 1, 2018, Medicaid managed care enrollees whose plan denies prior approval of a prescription drug, or discontinues a drug that had been approved, will receive an Initial Adverse Determination notice from the plan - See Model Denial IAD Notice and IAD Notice to Reduce, Suspend or Stop Services The enrollee must first request what is levitra used for an internal Plan Appeal and wait for the Plan's decision. An adverse decision is called a 'FInal Adverse Determination" or FAD. See model Denial FAD Notice and FAD Notice to Reduce, Suspend or Stop Services.

The enroll has the right what is levitra used for to request a fair hearing to appeal an FAD. The enrollee may only request a fair hearing BEFORE receiving the FAD if the plan fails to send the FAD in the required time limit, which is 30 calendar days in standard appeals, and 72 hours in expedited appeals. The plan may extend the time to decide both standard and expedited appeals by up to 14 days if more information is needed and it is in the enrollee's interest. AID CONTINUING -- If an enrollee requests a Plan Appeal and then a fair hearing because access to a drug what is levitra used for has been reduced or terminated, the enrollee has the right to aid continuing (continued access to the drug in question) while waiting for the Plan Appeal and then the fair hearing.

The enrollee must request the Plan Appeal and then the Fair Hearing before the effective date of the IAD and FAD notices, which is a very short time - only 10 days including mailing time. See more about the changes in Managed Care appeals here. Even though that article what is levitra used for is focused on Managed Long Term Care, the new appeals requirements also apply to Mainstream Medicaid managed care. Enrollees who are in the first 90 days of enrollment, or past the first 12 months of enrollment also have the option of switching plans to improve access to their medications.

Consumers who experience problems with access to prescription drugs should always file a complaint with the State Department of Health’s Managed Care Hotline, number listed below. ACCESSING MEDICAID'S PHARMACY BENEFIT IN FEE FOR SERVICE MEDICAID For those Medicaid recipients who are not yet in a what is levitra used for Medicaid Managed Care program, and who do not have Medicare Part D, the Medicaid Pharmacy program covers most of their prescription drugs and select non-prescription drugs and medical supplies for Family Health Plus enrollees. Certain drugs/drug categories require the prescribers to obtain prior authorization. These include brand name drugs that have a generic alternative under New York's mandatory generic drug program or prescribed drugs that are not on New York's preferred drug list.

The full what is levitra used for Medicaid formulary can be searched on the eMedNY website. Even in fee for service Medicaid, prescribers must obtain prior authorization before prescribing non-preferred drugs unless otherwise indicated. Prior authorization is required for original prescriptions, not refills. A prior authorization is effective for the original dispensing and up to five refills of that prescription within the next what is levitra used for six months.

Click here for more information on NY's prior authorization process. The New York State Board of Pharmacy publishes an annual list of the 150 most frequently prescribed drugs, in the most common quantities. The State what is levitra used for Department of Health collects retail price information on these drugs from pharmacies that participate in the Medicaid program. Click here to search for a specific drug from the most frequently prescribed drug list and this site can also provide you with the locations of pharmacies that provide this drug as well as their costs.

Click here to view New York State Medicaid’s Pharmacy Provider Manual. WHO YOU CAN CALL FOR HELP Community Health Advocates Hotline what is levitra used for. 1-888-614-5400 NY State Department of Health's Managed Care Hotline. 1-800-206-8125 (Mon.

- Fri what is levitra used for. 8:30 am - 4:30 pm) NY State Department of Insurance. 1-800-400-8882 NY State Attorney General's Health Care Bureau. 1-800-771-7755Haitian individuals and immigrants from some other countries who have applied for Temporary Protected Status (TPS) may be eligible for public health insurance what is levitra used for in New York State.

2019 updates - The Trump administration has taken steps to end TPS status. Two courts have temporarily enjoined the termination of TPS, one in New York State in April 2019 and one in California in October 2018. The California case was argued in an appeals court on what is levitra used for August 14, 2019, which the LA Times reported looked likely to uphold the federal action ending TPS. See US Immigration Website on TPS - General TPS website with links to status in all countries, including HAITI.

See also Pew Research March 2019 article. Courts Block Changes in what is levitra used for Public charge rule- See updates on the Public Charge rule here, blocked by federal court injunctions in October 2019. Read more about this change in public charge rules here. What is Temporary Protected Status?.

TPS is a temporary immigration status granted to eligible individuals of a certain country designated by the Department of Homeland Security because serious temporary conditions in that country, such as what is levitra used for armed conflict or environmental disaster, prevents people from that country to return safely. On January 21, 2010 the United States determined that individuals from Haiti warranted TPS because of the devastating earthquake that occurred there on January 12. TPS gives undocumented Haitian residents, who were living in the U.S. On January 12, 2010, protection from forcible deportation what is levitra used for and allows them to work legally.

It is important to note that the U.S. Grants TPS to individuals from other countries, as well, including individuals from El Salvador, Honduras, Nicaragua, Somalia and Sudan. TPS and Public Health Insurance TPS applicants residing in New York are eligible what is levitra used for for Medicaid and Family Health Plus as long as they also meet the income requirements for these programs. In New York, applicants for TPS are considered PRUCOL immigrants (Permanently Residing Under Color of Law) for purposes of medical assistance eligibility and thus meet the immigration status requirements for Medicaid, Family Health Plus, and the Family Planning Benefit Program.

Nearly all children in New York remain eligible for Child Health Plus including TPS applicants and children who lack immigration status. For what is levitra used for more information on immigrant eligibility for public health insurance in New York see 08 GIS MA/009 and the attached chart. Where to Apply What to BringIndividuals who have applied for TPS will need to bring several documents to prove their eligibility for public health insurance. Individuals will need to bring.

1) Proof what is levitra used for of identity. 2) Proof of residence in New York. 3) Proof of income. 4) what is levitra used for Proof of application for TPS.

5) Proof that U.S. Citizenship and Immigration Services (USCIS) has received the application for TPS. Free Communication Assistance All applicants for public health insurance, including Haitian Creole speakers, have a right to what is levitra used for get help in a language they can understand. All Medicaid offices and enrollers are required to offer free translation and interpretation services to anyone who cannot communicate effectively in English.

A bilingual worker or an interpreter, whether in-person or over the telephone, must be provided in all interactions with the office. Important documents, such as Medicaid applications, should be translated either orally what is levitra used for or in writing. Interpreter services must be offered free of charge, and applicants requiring interpreter services must not be made to wait unreasonably longer than English speaking applicants. An applicant must never be asked to bring their own interpreter.

Related Resources on TPS and Public Health Insurance o The New York Immigration Coalition (NYIC) has compiled a list of agencies, law firms, and law schools responding to the tragedy in Haiti and the designation of Haiti for Temporary Protected Status. A copy of the list is posted at the NYIC’s website at http://www.thenyic.org. o USCIS TPS website with links to status in all countries, including HAITI. O For information on eligibility for public health insurance programs call The Legal Aid Society’s Benefits Hotline 1-888-663-6880 Tuesdays, Wednesdays and Thursdays.

9:30 am - 12:30 pm FOR IMMIGRATION HELP. CONTACT THE New York State New Americans Hotline for a referral to an organization to advise you. 212-419-3737 Monday-Friday, from 9:00 a.m. To 8:00 p.m.Saturday-Sunday, from 9:00 a.m.

To 5:00 p.m. Or call toll-free in New York State at 1-800-566-7636 Please see these fact sheets and web sites of national organizations for more information about the new PUBLIC CHARGE rules. Printable Fact Sheets for Distribution This article was co-authored by the New York Immigration Coalition, Empire Justice Center and the Health Law Unit of the Legal Aid Society. 1/29/10, updated 3/1/10, updated 8/15/19 by NY Legal Assistance Group.

Before that date, people enrolled in a Medicaid managed care plan obtained all of their health care through the plan, but used Viagra online canada their canada levitra online regular Medicaid card to access any drug available on the state formulary on a "fee for service" basis without needing to utilize a restricted pharmacy network or comply with managed care plan rules. COMING IN April 2021 - In the NYS Budget enacted in April 2020, the pharmacy benefit was "carved out" of "mainstream" Medicaid managed care plans. That means that members of managed care plans will access their drugs outside their plan, unlike the rest of their medical care, which is accessed from in-network providers.

How Prescription Drugs are Obtained through Managed Care plans No - Until April 2020 HOW DO canada levitra online MANAGED CARE PLANS DEFINE THE PHARMACY BENEFIT FOR CONSUMERS?. The Medicaid pharmacy benefit includes all FDA approved prescription drugs, as well as some over-the-counter drugs and medical supplies. Under Medicaid managed care.

Plan formularies will be comparable to but not the same as the Medicaid canada levitra online formulary. Managed care plans are required to have drug formularies that are “comparable” to the Medicaid fee for service formulary. Plan formularies do not have to include all drugs covered listed on the fee for service formulary, but they must include generic or therapeutic equivalents of all Medicaid covered drugs.

The Pharmacy canada levitra online Benefit will vary by plan. Each plan will have its own formulary and drug coverage policies like prior authorization and step therapy. Pharmacy networks can also differ from plan to plan.

Prescriber Prevails applies canada levitra online in certain drug classes. Prescriber prevails applys to medically necessary precription drugs in the following classes. atypical antipsychotics, anti-depressants, anti-retrovirals, anti-rejection, seizure, epilepsy, endocrine, hemotologic and immunologic therapeutics.

Prescribers will need to demonstrate reasonable profession judgment and supply plans canada levitra online witht requested information and/or clinical documentation. Pharmacy Benefit Information Website -- http://mmcdruginformation.nysdoh.suny.edu/-- This website provides very helpful information on a plan by plan basis regarding pharmacy networks and drug formularies. The Department of Health plans to build capacity for interactive searches allowing for comparison of coverage across plans in the near future.

Standardized Prior Autorization (PA) Form -- The Department of Health worked with managed care plans, provider organizations and other state agencies to develop a standard prior authorization form for the pharmacy benefit in canada levitra online Medicaid managed care. The form will be posted on the Pharmacy Information Website in July of 2013. Mail Order Drugs -- Medicaid managed care members can obtain mail order/specialty drugs at any retail network pharmacy, as long as that retail network pharmacy agrees to a price that is comparable to the mail order/specialty pharmacy price.

CAN CONSUMERS canada levitra online SWITCH PLANS IN ORDER TO GAIN ACCESS TO DRUGS?. Changing plans is often an effective strategy for consumers eligible for both Medicaid and Medicare (dual eligibles) who receive their pharmacy service through Medicare Part D, because dual eligibles are allowed to switch plans at any time. Medicaid consumers will have this option only in the limited circumstances during the first year of enrollment in managed care.

Medicaid managed care enrollees can only leave and join another plan within the first 90 days of joining a canada levitra online health plan. After the 90 days has expired, enrollees are “locked in” to the plan for the rest of the year. Consumers can switch plans during the “lock in” period only for good cause.

The pharmacy benefit changes canada levitra online are not considered good cause. After the first 12 months of enrollment, Medicaid managed care enrollees can switch plans at any time. STEPS CONSUMERS CAN TAKE WHEN A MANAGED CARE PLAM DENIES ACCESS TO A NECESSARY DRUG As a first step, consumers should try to work with their providers to satisfy plan requirements for prior authorization or step therapy or any other utilization control requirements.

If the plan still denies access, consumers can pursue review processes specific to managed care while at the same time pursuing canada levitra online a fair hearing. All plans are required to maintain an internal and external review process for complaints and appeals of service denials. Some plans may develop special procedures for drug denials.

Information canada levitra online on these procedures should be provided in member handbooks. Beginning April 1, 2018, Medicaid managed care enrollees whose plan denies prior approval of a prescription drug, or discontinues a drug that had been approved, will receive an Initial Adverse Determination notice from the plan - See Model Denial IAD Notice and IAD Notice to Reduce, Suspend or Stop Services The enrollee must first request an internal Plan Appeal and wait for the Plan's decision. An adverse decision is called a 'FInal Adverse Determination" or FAD.

See model canada levitra online Denial FAD Notice and FAD Notice to Reduce, Suspend or Stop Services. The enroll has the right to request a fair hearing to appeal an FAD. The enrollee may only request a fair hearing BEFORE receiving the FAD if the plan fails to send the FAD in the required time limit, which is 30 calendar days in standard appeals, and 72 hours in expedited appeals.

The plan may extend the time to decide both standard and expedited appeals by up to 14 canada levitra online days if more information is needed and it is in the enrollee's interest. AID CONTINUING -- If an enrollee requests a Plan Appeal and then a fair hearing because access to a drug has been reduced or terminated, the enrollee has the right to aid continuing (continued access to the drug in question) while waiting for the Plan Appeal and then the fair hearing. The enrollee must request the Plan Appeal and then the Fair Hearing before the effective date of the IAD and FAD notices, which is a very short time - only 10 days including mailing time.

See more about the changes canada levitra online in Managed Care appeals here. Even though that article is focused on Managed Long Term Care, the new appeals requirements also apply to Mainstream Medicaid managed care. Enrollees who are in the first 90 days of enrollment, or past the first 12 months of enrollment also have the option of switching plans to improve access to their medications.

Consumers who experience problems with access to canada levitra online prescription drugs should always file a complaint with the State Department of Health’s Managed Care Hotline, number listed below. ACCESSING MEDICAID'S PHARMACY BENEFIT IN FEE FOR SERVICE MEDICAID For those Medicaid recipients who are not yet in a Medicaid Managed Care program, and who do not have Medicare Part D, the Medicaid Pharmacy program covers most of their prescription drugs and select non-prescription drugs and medical supplies for Family Health Plus enrollees. Certain drugs/drug categories require the prescribers to obtain prior authorization.

These include brand name drugs that have a generic alternative under New York's mandatory generic drug program or prescribed drugs that are not canada levitra online on New York's preferred drug list. The full Medicaid formulary can be searched on the eMedNY website. Even in fee for service Medicaid, prescribers must obtain prior authorization before prescribing non-preferred drugs unless otherwise indicated.

Prior authorization canada levitra online is required for original prescriptions, not refills. A prior authorization is effective for the original dispensing and up to five refills of that prescription within the next six months. Click here for more information on NY's prior authorization process.

The New York State Board canada levitra online of Pharmacy publishes an annual list of the 150 most frequently prescribed drugs, in the most common quantities. The State Department of Health collects retail price information on these drugs from pharmacies that participate in the Medicaid program. Click here to search for a specific drug from the most frequently prescribed drug list and this site can also provide you with the locations of pharmacies that provide this drug as well as their costs.

Click here to view New York State Medicaid’s Pharmacy canada levitra online Provider Manual. WHO YOU CAN CALL FOR HELP Community Health Advocates Hotline. 1-888-614-5400 NY State Department of Health's Managed Care Hotline.

1-800-206-8125 (Mon canada levitra online. - Fri. 8:30 am - 4:30 pm) NY State Department of Insurance.

1-800-400-8882 NY canada levitra online State Attorney General's Health Care Bureau. 1-800-771-7755Haitian individuals and immigrants from some other countries who have applied for Temporary Protected Status (TPS) may be eligible for public health insurance in New York State. 2019 updates - The Trump administration has taken steps to end TPS status.

Two courts have canada levitra online temporarily enjoined the termination of TPS, one in New York State in April 2019 and one in California in October 2018. The California case was argued in an appeals court on August 14, 2019, which the LA Times reported looked likely to uphold the federal action ending TPS. See US Immigration Website on TPS - General TPS website with links to status in all countries, including HAITI.

See also Pew Research March 2019 canada levitra online article. Courts Block Changes in Public charge rule- See updates on the Public Charge rule here, blocked by federal court injunctions in October 2019. Read more about this change in public charge rules here.

What is canada levitra online Temporary Protected Status?. TPS is a temporary immigration status granted to eligible individuals of a certain country designated by the Department of Homeland Security because serious temporary conditions in that country, such as armed conflict or environmental disaster, prevents people from that country to return safely. On January 21, 2010 the United States determined that individuals from Haiti warranted TPS because of the devastating earthquake that occurred there on January 12.

TPS gives undocumented Haitian residents, who were living in the canada levitra online U.S. On January 12, 2010, protection from forcible deportation and allows them to work legally. It is important to note that the U.S.

Grants TPS to individuals from other countries, as well, including individuals from El Salvador, Honduras, canada levitra online Nicaragua, Somalia and Sudan. TPS and Public Health Insurance TPS applicants residing in New York are eligible for Medicaid and Family Health Plus as long as they also meet the income requirements for these programs. In New York, applicants for TPS are considered PRUCOL immigrants (Permanently Residing Under Color of Law) for purposes of medical assistance eligibility and thus meet the immigration status requirements for Medicaid, Family Health Plus, and the Family Planning Benefit Program.

Nearly all children in New York remain eligible for Child Health Plus canada levitra online including TPS applicants and children who lack immigration status. For more information on immigrant eligibility for public health insurance in New York see 08 GIS MA/009 and the attached chart. Where to Apply What to BringIndividuals who have applied for TPS will need to bring several documents to prove their eligibility for public health insurance.

Individuals will need to canada levitra online bring. 1) Proof of identity. 2) Proof of residence in New York.

3) Proof of canada levitra online income. 4) Proof of application for TPS. 5) Proof that U.S.

Citizenship and Immigration Services (USCIS) has canada levitra online received the application for TPS. Free Communication Assistance All applicants for public health insurance, including Haitian Creole speakers, have a right to get help in a language they can understand. All Medicaid offices and enrollers are required to offer free translation and interpretation services to anyone who cannot communicate effectively in English.

A bilingual worker or an interpreter, whether in-person or over canada levitra online the telephone, must be provided in all interactions with the office. Important documents, such as Medicaid applications, should be translated either orally or in writing. Interpreter services must be offered free of charge, and applicants requiring interpreter services must not be made to wait unreasonably longer than English speaking applicants.

An applicant canada levitra online must never be asked to bring their own interpreter. Related Resources on TPS and Public Health Insurance o The New York Immigration Coalition (NYIC) has compiled a list of agencies, law firms, and law schools responding to the tragedy in Haiti and the designation of Haiti for Temporary Protected Status. A copy of the list is posted at the NYIC’s website at http://www.thenyic.org.

o USCIS TPS website with links to status in all countries, canada levitra online including HAITI. O For information on eligibility for public health insurance programs call The Legal Aid Society’s Benefits Hotline 1-888-663-6880 Tuesdays, Wednesdays and Thursdays. 9:30 am - 12:30 pm FOR IMMIGRATION HELP.

CONTACT THE New York State New Americans Hotline for a referral to an organization to advise you canada levitra online. 212-419-3737 Monday-Friday, from 9:00 a.m. To 8:00 p.m.Saturday-Sunday, from 9:00 a.m.

To 5:00 p.m. Or call toll-free in New York State at 1-800-566-7636 Please see these fact sheets and web sites of national organizations for more information about the new PUBLIC CHARGE rules. Printable Fact Sheets for Distribution This article was co-authored by the New York Immigration Coalition, Empire Justice Center and the Health Law Unit of the Legal Aid Society.

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Artificial intelligence technologies are being increasingly relied Buy amoxil without prescription upon in the healthcare domain, particularly when it comes to decision support, precision medicine, and levitra price per pill the improvement of the quality of care. Regarding primary levitra price per pill care specifically, AI also represents an opportunity to assist with electronic health record documentation. A new study published in the Journal of American Medical Informatics Association this week shows that, although AI documentation assistants (or digital scribes) offer great potential in the primary care setting, they will need to be supervised by a human until strong evidence is available for their autonomous potential. In workshops with primary care doctors, wrote researchers from the Australian Institute of levitra price per pill Health Innovation, "There was consensus that consultations of the future would increasingly involve more automated and AI-supported systems.

However, there were differing views on how this human-AI collaboration would work, what roles doctors and AI would take, and what tasks could be delegated to AI." HIMSS20 Digital Learn on-demand, earn credit, find products and solutions. Get Started levitra price per pill >>. WHY IT MATTERS Researchers worked with primary care doctors who use EHRs regularly for documentation purposes to understand their views on future AI documentation assistants. They identified levitra price per pill three major themes that emerged from the discussions.

Professional autonomy, human-AI collaboration and new models of care. First, the doctors emphasized the importance of their ability to care for patients in their own way with the abilities AI technology provided."If they levitra price per pill [patients] think that we're just getting suggestions from a computer, then maybe they can just get suggestions from a computer. I think it becomes more difficult to convince them that our recommendations are more valuable than what they can pick up on the internet," said one physician. They noted the need for a bottom-up approach to technology development, with a focus on delivering clear benefits to practice and workflow, levitra price per pill and expressed fears around potential legal complications that could stem from working with an AI assistant.With regard to human-AI collaboration, doctors expressed a variety of viewpoints about what tasks could be delegated to AI.

Many believed that an AI system could assist with tasks such as documentation, referrals and other paperwork. Most said that levitra price per pill AI systems would lack empathy. "GPs voiced several concerns, including some potential biases in patient data and system design, the time needed to fix the errors and train the system, challenges of dealing with complex cases, and the auditing of AI," wrote the researchers. However, doctors also discussed how AI could help with emerging levitra price per pill models of primary care, including preconsultation, mobile health and telehealth.

THE LARGER TREND The question of reducing EHR-related clinician burnout has loomed large, with vendors and researchers trying to pinpoint major causes – and, in turn, potential solutions. AI has levitra price per pill been raised as one such solution, with several major EHR vendors offering plans for incorporating the technology into their workflows. But human input remains vital, as the new JAMIA study and other research has noted. AI could "bring back meaning and purpose in the practice of levitra price per pill medicine while providing new levels of efficiency and accuracy," wrote Stanford researchers in a 2017 Journal of the American Medical Association study.

But, they continued, physicians must "proactively guide, oversee, and monitor the adoption of artificial intelligence as a partner in patient care."ON THE RECORD"AI documentation assistants will likely ... Be integral to the future primary care consultations levitra price per pill. However, these technologies will still need to be supervised by a human until strong evidence for reliable autonomous performance is available. Therefore, different human-AI collaboration models will need levitra price per pill to be designed and evaluated to ensure patient safety, quality of care, doctor safety, and doctor autonomy," wrote the Australian Institute for Health Innovation researchers.

Kat Jercich is senior editor of Healthcare IT News.Twitter. @kjercichHealthcare IT News is levitra price per pill a HIMSS Media publication.Konica Minolta Healthcare Americas will pay $500,000 to settle a whistleblower case that alleged its Viztek electronic health record subsidiary had falsified data for certification tests.WHY IT MATTERSIn the qui tam complaint, filed in 2017 in U.S. District Court in New Jersey – where Konica Minolta is based – was filed by whistleblower Leighsa Wilson, who worked for two years at Viztek, best known for its PACS and imaging technologies, as a project manager for its EXA EHR product.In mid-2015, the complaint alleges, Viztek, which was in negotiations to be acquired by Konica Minolta, worked together with InfoGard Laboratories (which was then an ONC-authorized certification and testing body) to make false representations that the EHR software complied with requirements for certification – and qualified for receipt of incentive payments under the federal meaningful use program."To ensure that their product was certified and that their customers received incentive payments, Viztek and Konica Minolta. (a) falsely attested to InfoGard that their software levitra price per pill met the certification criteria.

(b) hard-coded their software to pass certification testing requirements temporarily without ensuring that the software released to customers met certification criteria. And (c) caused their users to falsely attest to using a certified EHR technology, when their software could not support the applicable certification criteria in the field," according to the complaint, which also alleges that InfoGard "facilitated and participated in" these false attestations, "knowingly or with reckless disregard," certifying the EHR software despite its inability to meet ONC's certification criteria.The flaws in Viztek's software "not only rendered the system unreliable and unable to levitra price per pill meet meaningful use standards, but the flaws also created a risk to patient health and safety. Rather than spend the time and resources necessary to correct the flaws in its EHR software, the EHR defendants opted to do nothing."THE LARGER TRENDThis is only the most recent settlement of this type from health IT vendors accused of False Claims Act violations, of course.Most notable, was the case of eClinicalWorks, which was alleged by the Department of Justice to have falsely claimed meaningful use certification, to have neglected to have safety addressed issues in its software and to have paid kickbacks to clients. That case was settled in 2017 for $155 million.More recently, levitra price per pill similar complaints were lodged against companies such as Practice Fusion and Greenway Health.

They settled with DOJ for $145 million and $57 million, respectively."We will be unflagging in our efforts to preserve the accuracy and reliability of Americans’ health records and guard the public against corporate greed," said U.S. Attorney for the District of Vermont levitra price per pill Christina Nolan after the Greenway case this past year. "EHR companies should consider themselves on notice."ON THE RECORD"The lives of patients depend upon the information processed by electronic health records," said Wilson – who, as a qui tam whistleblower will receive 20% of the financial settlement – in a statement. "Functionality testing and subsequent certification must be performed and obtained through a reliable, measurable process.""Filing a qui tam lawsuit is a powerful and effective way to report problems with EHR software purchased with levitra price per pill federal funds and get the problems fixed when they are ignored," said Luke Diamond, an associate at Phillips &.

Cohen. "The False Claims Act protects whistleblowers from job retaliation and offers rewards if the government recovers funds as a result of the qui tam case.""Our client was concerned about possible patient harm that can occur if EHR software isn't properly certified, so she stepped forward to inform the government about levitra price per pill what she had witnessed," said Colette Matzzie, a partner and whistleblower attorney with Phillips &. Cohen, which brought the case. "Ensuring that EHR software meets all governmental requirements is important to safeguard both patient care and federal funds."The Arc Madison Cortland in Oneida, New York, knows that there is a lack of providers that specialize levitra price per pill in the intellectual/developmental disability field.

Making the levitra price per pill problem worse, not so many that understand dual diagnosis.THE PROBLEMWith erectile dysfunction treatment minimizing the ability for individuals to receive face-to-face services with their providers, many patients are resorting to emergency department visits.Additionally, The Arc is in a rural area requiring travel to see a provider, and there is a lack of providers in the field. The population itself is underserved, with a lack of transportation to get to appointments. Without the ability to institute telemedicine as a solution to these problems, the population supported by The Arc would have seen a levitra price per pill lengthy (permanent?. ) pause for needed medical services.PROPOSALThe Arc this year received funding from the FCC to help provide telehealth services.“With this funding we can further treat patients, reduce crisis and allow for social distancing, which is imperative to our vulnerable population,” said Jackie Fahey, director of clinic services at The Arc Madison Cortland.

€œWe could provide ongoing services to the levitra price per pill individuals we serve to ensure there are no unnecessary emergency department visits. This places less of a strain on our local emergency departments and unneeded additional costs.”With the purchase of tablets and headsets and telehealth services from vendor Doxy.me, The Arc was able to still provide medical care to its population of people with an I/DD. Additionally, eliminating emergency department visits also eliminates their exposure to erectile dysfunction treatment and levitra price per pill eases the burden of the ED providers who are overburdened right now.MARKETPLACEThere are many vendors of telemedicine technology and services on the health IT market today. Healthcare IT News recently compiled a comprehensive list of these vendors with detailed descriptions.

To read this special report, click here.MEETING THE CHALLENGE“When all of our locations were closed abruptly in the middle of March due to the erectile dysfunction treatment levitra, we needed to determine a way to quickly and easily implement levitra price per pill a telehealth solution so that we were able to still support the individuals that we serve during the crisis, especially when many were under strict quarantine protocols for a variety of reasons,” Fahey explained.“We signed up immediately for the Doxy.me telehealth platform as it was a user-friendly platform that is HIPAA-compliant. The feature we liked about Doxy.me was that it is web-based, so nothing had to be downloaded and it could easily be used on a laptop, tablet or smartphone.”The Arc rolled out the technology initially with its mental health providers, who offer psychiatry/medication monitoring services, social work counseling and mental health counseling. More than half the organization’s enrollment is enrolled in one or all of these three services, so it was able to continue providing services to a large number of enrolled individuals.“We then began to roll the telehealth services out to nutrition, levitra price per pill speech therapy, physical therapy and occupational therapy caseloads if individuals were appropriate to receive the service through telehealth,” Fahey said.RESULTSThe first success metric The Arc has been able to achieve with the technology is maintaining its utilization for mental health services. When everything was running normal prior to erectile dysfunction treatment, The Arc’s mental health services made up about 25% of the services it provided on a monthly basis.

With the implementation of telehealth services during the erectile dysfunction treatment levitra, the organization was able to achieve 20% of the services provided on a monthly basis.This has shown to staff that they have been able to still serve and respond to the needs of their levitra price per pill psychiatry, social work and mental health counseling patients with minimal issues by implementing the telehealth technology.“The second success metric we have been able to achieve with the technology is we have been able to continue to receive referrals for our services and enroll new individuals into the services they need if the services are able to be completed via telehealth,” she said. €œBetween April, May and June, we have enrolled 16 new individuals into ongoing clinic services, which is right on par for our normal enrollment average per month.”USING FCC AWARD FUNDSThe Arc Madison Cortland was awarded $49,455 by the FCC earlier this year for laptop computers and headsets to provide remote consultations and treatment during the erectile dysfunction treatment levitra for psychological services, counseling, and occupational and physical therapy for people with developmental and other disabilities.“With the funds, we purchased headsets and tablets to allow the people we support to have access to medical appointments, along with physical therapy, occupational therapy and psychology appointments remotely,” Fahey explained. €œThe technology enables us to continue to provide these services at a time when the people we support are unable to leave for traditional in-person appointments.“Because these are such uncertain times, and a time frame levitra price per pill for when we may return to ‘normalcy’ is unknown, the technology allows us to continue delivering medical support without the concern of a pause in those services.”Twitter. @SiwickiHealthITEmail the writer.

Bill.siwicki@himss.orgHealthcare IT News is a HIMSS Media publication.HIMSSCast host Jonah Comstock convenes a panel of HIMSS Media editors – HITN Senior Editor Kat Jercich, MobiHealthNews Associate Editor Dave Muoio and HFN Associate Editor Jeff Lagasse – to discuss recent delivery slowdowns at the Post Office and how they levitra price per pill have and haven't affected healthcare stakeholders, including startups and patients. The team also looks into the broader trend of the politicization of traditionally apolitical government agencies and how that could affect public faith in erectile dysfunction treatments or treatments.More about this episode:USPS service delays are hitting some mail-order pharmacies and telehealth platforms harder than othersMail delays may affect medication supply for nearly 1 in 4 Americans over 50Postmaster General Louis DeJoy's full testimony (C-SPAN)The Package Coalition homepageThe Trump administration this week asked the U.S. Supreme Court to reverse a lower court ruling that allowed for mail-order and levitra price per pill telemedicine abortion during the erectile dysfunction treatment crisis. U.S.

Food and Drug Administration regulations require mifepristone, which is used in medication abortion, to be dispensed at a clinic, hospital or medical levitra price per pill office. In June, U.S. District Judge for the District of Maryland Theodore Chuang blocked the requirements during the levitra, finding them to be a "substantial obstacle." Mifepristone, in combination with misoprostol, levitra price per pill is FDA-approved for abortions up to ten weeks' gestation. In 2017, a New England Journal of Medicine article argued against the FDA regulations for mifepristone given the drug's safety record.

WHY IT MATTERS Acting Solicitor General Jeffrey levitra price per pill B. Wall applied for a stay of Chuang's injunction on Wednesday as the case makes its way through the lower courts, arguing that the regulations do not represent an undue burden. "The safety requirements here concern only medication abortions using Mifeprex, which is approved levitra price per pill for use only during the first ten weeks of pregnancy. They have no effect on the availability of surgical abortions, a method that this Court has treated as safe for women," wrote Wall.

Reproductive rights groups spoke out against the move, noting that people of color are levitra price per pill disproportionately affected both by abortion restrictions and by the erectile dysfunction treatment levitra. "Black, Brown, Indigenous people and people of color are already dying/getting sick at disproportionate rates from erectile dysfunction treatment," said All Above All* on Twitter. "The Trump-Pence admin is trying to make this worse by asking SCOTUS to require people face unnecessary risk just to get abortion care." "The FDA’s in-person requirements on mifepristone subject patients to unnecessary exposure to a deadly levitra, and two federal courts have already rejected the Trump levitra price per pill administration’s argument. Forcing patients to travel to a health center to access the safe, effective medication they need especially hurts people of color and people with low-incomes, who already face more barriers to care," said Planned Parenthood Federation of America President and CEO Alexis McGill-Johnson in a statement.THE LARGER TREND The erectile dysfunction treatment levitra has exacerbated many existing barriers to care, including for reproductive health services.

"We’ve seen the undue burden and hardship these restrictions create during erectile dysfunction treatment, especially in communities hit hardest by levitra price per pill the levitra," said Skye Perryman, chief legal officer at the American College of Obstetricians and Gynecologists, a co-plaintiff in the telemedicine case, to Healthcare IT News. In response to the July ruling, some abortion providers reportedly moved to delivering mifepristone by mail. Still, levitra price per pill others faced state laws that restricted the provision of abortion via telemedicine.And as Dr. Jacquelyn Yeh from Physicians from Reproductive Health pointed out in July, telemedicine itself involves hurdles such as broadband access and privacy concerns.

It remains to be seen whether the Supreme Court levitra price per pill will grant the Trump administration's request. ON THE RECORD "As erectile dysfunction treatment ravages Black, Latino, Indigenous, and other communities of color across the country, the Trump administration should be aiming to keep us healthy – not moving forward with an agenda to endanger people who seek abortion," said McGill-Johnson. Kat Jercich is senior editor of Healthcare IT levitra price per pill News.Twitter. @kjercichHealthcare IT News is a HIMSS Media publication..

Artificial intelligence technologies are being increasingly relied upon in the healthcare domain, particularly when it comes to decision support, precision medicine, and the improvement of the quality of canada levitra online Buy amoxil without prescription care. Regarding primary care specifically, canada levitra online AI also represents an opportunity to assist with electronic health record documentation. A new study published in the Journal of American Medical Informatics Association this week shows that, although AI documentation assistants (or digital scribes) offer great potential in the primary care setting, they will need to be supervised by a human until strong evidence is available for their autonomous potential. In workshops with primary care doctors, wrote researchers from the canada levitra online Australian Institute of Health Innovation, "There was consensus that consultations of the future would increasingly involve more automated and AI-supported systems.

However, there were differing views on how this human-AI collaboration would work, what roles doctors and AI would take, and what tasks could be delegated to AI." HIMSS20 Digital Learn on-demand, earn credit, find products and solutions. Get Started canada levitra online >>. WHY IT MATTERS Researchers worked with primary care doctors who use EHRs regularly for documentation purposes to understand their views on future AI documentation assistants. They identified three canada levitra online major themes that emerged from the discussions.

Professional autonomy, human-AI collaboration and new models of care. First, the doctors emphasized the importance of their ability to care for patients in their own way with the abilities AI canada levitra online technology provided."If they [patients] think that we're just getting suggestions from a computer, then maybe they can just get suggestions from a computer. I think it becomes more difficult to convince them that our recommendations are more valuable than what they can pick up on the internet," said one physician. They noted the need for a bottom-up approach to technology development, with a focus on delivering clear benefits to practice and workflow, and expressed fears around potential legal canada levitra online complications that could stem from working with an AI assistant.With regard to human-AI collaboration, doctors expressed a variety of viewpoints about what tasks could be delegated to AI.

Many believed that an AI system could assist with tasks such as documentation, referrals and other paperwork. Most said that canada levitra online AI systems would lack empathy. "GPs voiced several concerns, including some potential biases in patient data and system design, the time needed to fix the errors and train the system, challenges of dealing with complex cases, and the auditing of AI," wrote the researchers. However, doctors also discussed how AI canada levitra online could help with emerging models of primary care, including preconsultation, mobile health and telehealth.

THE LARGER TREND The question of reducing EHR-related clinician burnout has loomed large, with vendors and researchers trying to pinpoint major causes – and, in turn, potential solutions. AI has been raised as one such solution, with several major EHR vendors offering plans for canada levitra online incorporating the technology into their workflows. But human input remains vital, as the new JAMIA study and other research has noted. AI could "bring back canada levitra online meaning and purpose in the practice of medicine while providing new levels of efficiency and accuracy," wrote Stanford researchers in a 2017 Journal of the American Medical Association study.

But, they continued, physicians must "proactively guide, oversee, and monitor the adoption of artificial intelligence as a partner in patient care."ON THE RECORD"AI documentation assistants will likely ... Be integral canada levitra online to the future primary care consultations. However, these technologies will still need to be supervised by a human until strong evidence for reliable autonomous performance is available. Therefore, different human-AI collaboration models will need to be canada levitra online designed and evaluated to ensure patient safety, quality of care, doctor safety, and doctor autonomy," wrote the Australian Institute for Health Innovation researchers.

Kat Jercich is senior editor of Healthcare IT News.Twitter. @kjercichHealthcare IT News is a HIMSS Media publication.Konica canada levitra online Minolta Healthcare Americas will pay $500,000 to settle a whistleblower case that alleged its Viztek electronic health record subsidiary had falsified data for certification tests.WHY IT MATTERSIn the qui tam complaint, filed in 2017 in U.S. District Court in New Jersey – where Konica Minolta is based – was filed by whistleblower Leighsa Wilson, who worked for two years at Viztek, best known for its PACS and imaging technologies, as a project manager for its EXA EHR product.In mid-2015, the complaint alleges, Viztek, which was in negotiations to be acquired by Konica Minolta, worked together with InfoGard Laboratories (which was then an ONC-authorized certification and testing body) to make false representations that the EHR software complied with requirements for certification – and qualified for receipt of incentive payments under the federal meaningful use program."To ensure that their product was certified and that their customers received incentive payments, Viztek and Konica Minolta. (a) falsely attested to InfoGard that their software met the certification criteria canada levitra online.

(b) hard-coded their software to pass certification testing requirements temporarily without ensuring that the software released to customers met certification criteria. And (c) caused their users to falsely attest to using a certified EHR technology, when their software could not support the applicable certification criteria in the field," according to the complaint, which also alleges that InfoGard "facilitated and participated in" these false attestations, "knowingly or with reckless disregard," certifying the EHR software despite canada levitra online its inability to meet ONC's certification criteria.The flaws in Viztek's software "not only rendered the system unreliable and unable to meet meaningful use standards, but the flaws also created a risk to patient health and safety. Rather than spend the time and resources necessary to correct the flaws in its EHR software, the EHR defendants opted to do nothing."THE LARGER TRENDThis is only the most recent settlement of this type from health IT vendors accused of False Claims Act violations, of course.Most notable, was the case of eClinicalWorks, which was alleged by the Department of Justice to have falsely claimed meaningful use certification, to have neglected to have safety addressed issues in its software and to have paid kickbacks to clients. That case was settled in 2017 for canada levitra online $155 million.More recently, similar complaints were lodged against companies such as Practice Fusion and Greenway Health.

They settled with DOJ for $145 million and $57 million, respectively."We will be unflagging in our efforts to preserve the accuracy and reliability of Americans’ health records and guard the public against corporate greed," said U.S. Attorney for the District of canada levitra online Vermont Christina Nolan after the Greenway case this past year. "EHR companies should consider themselves on notice."ON THE RECORD"The lives of patients depend upon the information processed by electronic health records," said Wilson – who, as a qui tam whistleblower will receive 20% of the financial settlement – in a statement. "Functionality testing and subsequent certification must be performed and obtained through a reliable, measurable process.""Filing a qui tam lawsuit is a canada levitra online powerful and effective way to report problems with EHR software purchased with federal funds and get the problems fixed when they are ignored," said Luke Diamond, an associate at Phillips &.

Cohen. "The False Claims Act protects whistleblowers from job retaliation and offers rewards if the government recovers funds as a result of the qui tam case.""Our client was concerned about possible patient harm that can occur if EHR software isn't properly certified, so she stepped forward to canada levitra online inform the government about what she had witnessed," said Colette Matzzie, a partner and whistleblower attorney with Phillips &. Cohen, which brought the case. "Ensuring that canada levitra online EHR software meets all governmental requirements is important to safeguard both patient care and federal funds."The Arc Madison Cortland in Oneida, New York, knows that there is a lack of providers that specialize in the intellectual/developmental disability field.

Making the problem worse, not so many that understand dual diagnosis.THE PROBLEMWith erectile dysfunction treatment minimizing the ability for individuals to receive face-to-face services with their providers, many patients are resorting to emergency department canada levitra online visits.Additionally, The Arc is in a rural area requiring travel to see a provider, and there is a lack of providers in the field. The population itself is underserved, with a lack of transportation to get to appointments. Without the ability to institute telemedicine as canada levitra online a solution to these problems, the population supported by The Arc would have seen a lengthy (permanent?. ) pause for needed medical services.PROPOSALThe Arc this year received funding from the FCC to help provide telehealth services.“With this funding we can further treat patients, reduce crisis and allow for social distancing, which is imperative to our vulnerable population,” said Jackie Fahey, director of clinic services at The Arc Madison Cortland.

€œWe could provide ongoing services to the individuals we serve to ensure there are no unnecessary emergency department canada levitra online visits. This places less of a strain on our local emergency departments and unneeded additional costs.”With the purchase of tablets and headsets and telehealth services from vendor Doxy.me, The Arc was able to still provide medical care to its population of people with an I/DD. Additionally, eliminating emergency department visits also eliminates their exposure to erectile dysfunction treatment and eases the burden of the ED providers who are overburdened right now.MARKETPLACEThere are many vendors of telemedicine technology and canada levitra online services on the health IT market today. Healthcare IT News recently compiled a comprehensive list of these vendors with detailed descriptions.

To read this special report, click here.MEETING THE CHALLENGE“When all of our locations were closed abruptly in the middle of March due to the erectile dysfunction treatment levitra, we needed to determine a way to quickly and easily implement a telehealth solution so that we were able to still support the individuals that we serve during the crisis, especially when many were under strict quarantine protocols for a variety of reasons,” Fahey explained.“We signed up immediately for the Doxy.me telehealth platform as it was a user-friendly platform that is HIPAA-compliant canada levitra online. The feature we liked about Doxy.me was that it is web-based, so nothing had to be downloaded and it could easily be used on a laptop, tablet or smartphone.”The Arc rolled out the technology initially with its mental health providers, who offer psychiatry/medication monitoring services, social work counseling and mental health counseling. More than half canada levitra online the organization’s enrollment is enrolled in one or all of these three services, so it was able to continue providing services to a large number of enrolled individuals.“We then began to roll the telehealth services out to nutrition, speech therapy, physical therapy and occupational therapy caseloads if individuals were appropriate to receive the service through telehealth,” Fahey said.RESULTSThe first success metric The Arc has been able to achieve with the technology is maintaining its utilization for mental health services. When everything was running normal prior to erectile dysfunction treatment, The Arc’s mental health services made up about 25% of the services it provided on a monthly basis.

With the implementation of telehealth services during the erectile dysfunction treatment levitra, the canada levitra online organization was able to achieve 20% of the services provided on a monthly basis.This has shown to staff that they have been able to still serve and respond to the needs of their psychiatry, social work and mental health counseling patients with minimal issues by implementing the telehealth technology.“The second success metric we have been able to achieve with the technology is we have been able to continue to receive referrals for our services and enroll new individuals into the services they need if the services are able to be completed via telehealth,” she said. €œBetween April, May and June, we have enrolled 16 new individuals into ongoing clinic services, which is right on par for our normal enrollment average per month.”USING FCC AWARD FUNDSThe Arc Madison Cortland was awarded $49,455 by the FCC earlier this year for laptop computers and headsets to provide remote consultations and treatment during the erectile dysfunction treatment levitra for psychological services, counseling, and occupational and physical therapy for people with developmental and other disabilities.“With the funds, we purchased headsets and tablets to allow the people we support to have access to medical appointments, along with physical therapy, occupational therapy and psychology appointments remotely,” Fahey explained. €œThe technology enables us to continue to provide these services at a time when the people we support are unable to leave for traditional in-person appointments.“Because these are such uncertain times, and a time frame for when we may return to canada levitra online ‘normalcy’ is unknown, the technology allows us to continue delivering medical support without the concern of a pause in those services.”Twitter. @SiwickiHealthITEmail the writer.

Bill.siwicki@himss.orgHealthcare IT News is a HIMSS Media publication.HIMSSCast host Jonah Comstock convenes a panel of HIMSS Media editors – HITN Senior Editor Kat Jercich, MobiHealthNews Associate Editor Dave Muoio and HFN Associate Editor Jeff Lagasse – to discuss recent delivery slowdowns at the Post Office and how they have and haven't affected healthcare stakeholders, including startups canada levitra online and patients. The team also looks into the broader trend of the politicization of traditionally apolitical government agencies and how that could affect public faith in erectile dysfunction treatments or treatments.More about this episode:USPS service delays are hitting some mail-order pharmacies and telehealth platforms harder than othersMail delays may affect medication supply for nearly 1 in 4 Americans over 50Postmaster General Louis DeJoy's full testimony (C-SPAN)The Package Coalition homepageThe Trump administration this week asked the U.S. Supreme Court to reverse a lower court canada levitra online ruling that allowed for mail-order and telemedicine abortion during the erectile dysfunction treatment crisis. U.S.

Food and Drug Administration regulations require mifepristone, which is canada levitra online used in medication abortion, to be dispensed at a clinic, hospital or medical office. In June, U.S. District Judge for canada levitra online the District of Maryland Theodore Chuang blocked the requirements during the levitra, finding them to be a "substantial obstacle." Mifepristone, in combination with misoprostol, is FDA-approved for abortions up to ten weeks' gestation. In 2017, a New England Journal of Medicine article argued against the FDA regulations for mifepristone given the drug's safety record.

WHY IT MATTERS Acting Solicitor canada levitra online General Jeffrey B. Wall applied for a stay of Chuang's injunction on Wednesday as the case makes its way through the lower courts, arguing that the regulations do not represent an undue burden. "The safety requirements here concern only canada levitra online medication abortions using Mifeprex, which is approved for use only during the first ten weeks of pregnancy. They have no effect on the availability of surgical abortions, a method that this Court has treated as safe for women," wrote Wall.

Reproductive rights groups spoke out against the move, noting that people of color are disproportionately affected both by abortion restrictions and canada levitra online by the erectile dysfunction treatment levitra. "Black, Brown, Indigenous people and people of color are already dying/getting sick at disproportionate rates from erectile dysfunction treatment," said All Above All* on Twitter. "The Trump-Pence admin is trying canada levitra online to make this worse by asking SCOTUS to require people face unnecessary risk just to get abortion care." "The FDA’s in-person requirements on mifepristone subject patients to unnecessary exposure to a deadly levitra, and two federal courts have already rejected the Trump administration’s argument. Forcing patients to travel to a health center to access the safe, effective medication they need especially hurts people of color and people with low-incomes, who already face more barriers to care," said Planned Parenthood Federation of America President and CEO Alexis McGill-Johnson in a statement.THE LARGER TREND The erectile dysfunction treatment levitra has exacerbated many existing barriers to care, including for reproductive health services.

"We’ve seen the undue burden and hardship these restrictions create during erectile dysfunction treatment, especially in communities hit hardest by the levitra," said Skye Perryman, chief legal officer at the American College of Obstetricians and canada levitra online Gynecologists, a co-plaintiff in the telemedicine case, to Healthcare IT News. In response to the July ruling, some abortion providers reportedly moved to delivering mifepristone by mail. Still, others canada levitra online faced state laws that restricted the provision of abortion via telemedicine.And as Dr. Jacquelyn Yeh from Physicians from Reproductive Health pointed out in July, telemedicine itself involves hurdles such as broadband access and privacy concerns.

It remains to be seen whether canada levitra online the Supreme Court will grant the Trump administration's request. ON THE RECORD "As erectile dysfunction treatment ravages Black, Latino, Indigenous, and other communities of color across the country, the Trump administration should be aiming to keep us healthy – not moving forward with an agenda to endanger people who seek abortion," said McGill-Johnson. Kat Jercich is senior editor canada levitra online of Healthcare IT News.Twitter. @kjercichHealthcare IT News is a HIMSS Media publication..

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Trial Population Table buy brand levitra online helpful resources 1. Table 1. Characteristics of the Participants in the mRNA-1273 buy brand levitra online Trial at Enrollment.

The 45 enrolled participants received their first vaccination between March 16 and April 14, 2020 (Fig. S1). Three participants did not receive the second vaccination, including one in the 25-μg group who had urticaria on both legs, with onset 5 days after the first vaccination, and two (one in the 25-μg group and one in the 250-μg group) who missed the second vaccination window owing to isolation for suspected erectile dysfunction treatment while the test results, ultimately negative, were pending.

All continued to attend scheduled trial visits. The demographic characteristics of participants at enrollment are provided in Table 1. treatment Safety No serious adverse events were noted, and no prespecified trial halting rules were met.

As noted above, one participant in the 25-μg group was withdrawn because of an unsolicited adverse event, transient urticaria, judged to be related to the first vaccination. Figure 1. Figure 1.

Systemic and Local Adverse Events. The severity of solicited adverse events was graded as mild, moderate, or severe (see Table S1).After the first vaccination, solicited systemic adverse events were reported by 5 participants (33%) in the 25-μg group, 10 (67%) in the 100-μg group, and 8 (53%) in the 250-μg group. All were mild or moderate in severity (Figure 1 and Table S2).

Solicited systemic adverse events were more common after the second vaccination and occurred in 7 of 13 participants (54%) in the 25-μg group, all 15 in the 100-μg group, and all 14 in the 250-μg group, with 3 of those participants (21%) reporting one or more severe events. None of the participants had fever after the first vaccination. After the second vaccination, no participants in the 25-μg group, 6 (40%) in the 100-μg group, and 8 (57%) in the 250-μg group reported fever.

One of the events (maximum temperature, 39.6°C) in the 250-μg group was graded severe. (Additional details regarding adverse events for that participant are provided in the Supplementary Appendix.) Local adverse events, when present, were nearly all mild or moderate, and pain at the injection site was common. Across both vaccinations, solicited systemic and local adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site.

Evaluation of safety clinical laboratory values of grade 2 or higher and unsolicited adverse events revealed no patterns of concern (Supplementary Appendix and Table S3). erectile dysfunction Binding Antibody Responses Table 2. Table 2.

Geometric Mean Humoral Immunogenicity Assay Responses to mRNA-1273 in Participants and in Convalescent Serum Specimens. Figure 2. Figure 2.

erectile dysfunction Antibody and Neutralization Responses. Shown are geometric mean reciprocal end-point enzyme-linked immunosorbent assay (ELISA) IgG titers to S-2P (Panel A) and receptor-binding domain (Panel B), PsVNA ID50 responses (Panel C), and live levitra PRNT80 responses (Panel D). In Panel A and Panel B, boxes and horizontal bars denote interquartile range (IQR) and median area under the curve (AUC), respectively.

Whisker endpoints are equal to the maximum and minimum values below or above the median ±1.5 times the IQR. The convalescent serum panel includes specimens from 41 participants. Red dots indicate the 3 specimens that were also tested in the PRNT assay.

The other 38 specimens were used to calculate summary statistics for the box plot in the convalescent serum panel. In Panel C, boxes and horizontal bars denote IQR and median ID50, respectively. Whisker end points are equal to the maximum and minimum values below or above the median ±1.5 times the IQR.

In the convalescent serum panel, red dots indicate the 3 specimens that were also tested in the PRNT assay. The other 38 specimens were used to calculate summary statistics for the box plot in the convalescent panel. In Panel D, boxes and horizontal bars denote IQR and median PRNT80, respectively.

Whisker end points are equal to the maximum and minimum values below or above the median ±1.5 times the IQR. The three convalescent serum specimens were also tested in ELISA and PsVNA assays. Because of the time-intensive nature of the PRNT assay, for this preliminary report, PRNT results were available only for the 25-μg and 100-μg dose groups.Binding antibody IgG geometric mean titers (GMTs) to S-2P increased rapidly after the first vaccination, with seroconversion in all participants by day 15 (Table 2 and Figure 2A).

Dose-dependent responses to the first and second vaccinations were evident. Receptor-binding domain–specific antibody responses were similar in pattern and magnitude (Figure 2B). For both assays, the median magnitude of antibody responses after the first vaccination in the 100-μg and 250-μg dose groups was similar to the median magnitude in convalescent serum specimens, and in all dose groups the median magnitude after the second vaccination was in the upper quartile of values in the convalescent serum specimens.

The S-2P ELISA GMTs at day 57 (299,751 [95% confidence interval {CI}, 206,071 to 436,020] in the 25-μg group, 782,719 [95% CI, 619,310 to 989,244] in the 100-μg group, and 1,192,154 [95% CI, 924,878 to 1,536,669] in the 250-μg group) exceeded that in the convalescent serum specimens (142,140 [95% CI, 81,543 to 247,768]). erectile dysfunction Neutralization Responses No participant had detectable PsVNA responses before vaccination. After the first vaccination, PsVNA responses were detected in less than half the participants, and a dose effect was seen (50% inhibitory dilution [ID50].

Figure 2C, Fig. S8, and Table 2. 80% inhibitory dilution [ID80].

Fig. S2 and Table S6). However, after the second vaccination, PsVNA responses were identified in serum samples from all participants.

The lowest responses were in the 25-μg dose group, with a geometric mean ID50 of 112.3 (95% CI, 71.2 to 177.1) at day 43. The higher responses in the 100-μg and 250-μg groups were similar in magnitude (geometric mean ID50, 343.8 [95% CI, 261.2 to 452.7] and 332.2 [95% CI, 266.3 to 414.5], respectively, at day 43). These responses were similar to values in the upper half of the distribution of values for convalescent serum specimens.

Before vaccination, no participant had detectable 80% live-levitra neutralization at the highest serum concentration tested (1:8 dilution) in the PRNT assay. At day 43, wild-type levitra–neutralizing activity capable of reducing erectile dysfunction infectivity by 80% or more (PRNT80) was detected in all participants, with geometric mean PRNT80 responses of 339.7 (95% CI, 184.0 to 627.1) in the 25-μg group and 654.3 (95% CI, 460.1 to 930.5) in the 100-μg group (Figure 2D). Neutralizing PRNT80 average responses were generally at or above the values of the three convalescent serum specimens tested in this assay.

Good agreement was noted within and between the values from binding assays for S-2P and receptor-binding domain and neutralizing activity measured by PsVNA and PRNT (Figs. S3 through S7), which provides orthogonal support for each assay in characterizing the humoral response induced by mRNA-1273. erectile dysfunction T-Cell Responses The 25-μg and 100-μg doses elicited CD4 T-cell responses (Figs.

S9 and S10) that on stimulation by S-specific peptide pools were strongly biased toward expression of Th1 cytokines (tumor necrosis factor α >. Interleukin 2 >. Interferon γ), with minimal type 2 helper T-cell (Th2) cytokine expression (interleukin 4 and interleukin 13).

CD8 T-cell responses to S-2P were detected at low levels after the second vaccination in the 100-μg dose group (Fig. S11).Study Design and Participants To reduce the risk of introducing erectile dysfunction into basic training at Marine Corps Recruit Depot, Parris Island, in South Carolina, the Marine Corps established a 14-day supervised quarantine period at a college campus used exclusively for this purpose. Potential recruits were instructed to quarantine at home for 2 weeks immediately before they traveled to campus.

At the end of the second, supervised quarantine on campus, all recruits were required to have a negative qPCR result before they could enter Parris Island. Recruits were asked to participate in the erectile dysfunction treatment Health Action Response for Marines (CHARM) study, which included weekly qPCR testing and blood sampling for IgG antibody assessment. After potential recruits had completed the 14-day home quarantine, they presented to a local Military Entrance Processing Station, where a medical history was taken and a physical examination was performed.

If potential recruits were deemed to be physically and mentally fit for enlistment, they were instructed to wear masks at all times and maintain social distancing of at least 6 feet during travel to the quarantine campus. Classes of 350 to 450 recruits arrived on campus nearly weekly. New classes were divided into platoons of 50 to 60 recruits, and roommates were assigned independently of participation in the CHARM study.

Overlapping classes were housed in different dormitories and had different dining times and training schedules. During the supervised quarantine, public health measures were enforced to suppress erectile dysfunction transmission (Table S1 in the Supplementary Appendix, available with the full text of this article at NEJM.org). All recruits wore double-layered cloth masks at all times indoors and outdoors, except when sleeping or eating.

Practiced social distancing of at least 6 feet. Were not allowed to leave campus. Did not have access to personal electronics and other items that might contribute to surface transmission.

And routinely washed their hands. They slept in double-occupancy rooms with sinks, ate in shared dining facilities, and used shared bathrooms. All recruits cleaned their rooms daily, sanitized bathrooms after each use with bleach wipes, and ate preplated meals in a dining hall that was cleaned with bleach after each platoon had eaten.

Most instruction and exercises were conducted outdoors. All movement of recruits was supervised, and unidirectional flow was implemented, with designated building entry and exit points to minimize contact among persons. All recruits, regardless of participation in the study, underwent daily temperature and symptom screening.

Six instructors who were assigned to each platoon worked in 8-hour shifts and enforced the quarantine measures. If recruits reported any signs or symptoms consistent with erectile dysfunction treatment, they reported to sick call, underwent rapid qPCR testing for erectile dysfunction, and were placed in isolation pending the results of testing. Instructors were also restricted to campus, were required to wear masks, were provided with preplated meals, and underwent daily temperature checks and symptom screening.

Instructors who were assigned to a platoon in which a positive case was diagnosed underwent rapid qPCR testing for erectile dysfunction, and, if the result was positive, the instructor was removed from duty. Recruits and instructors were prohibited from interacting with campus support staff, such as janitorial and food-service personnel. After each class completed quarantine, a deep bleach cleaning of surfaces was performed in the bathrooms, showers, bedrooms, and hallways in the dormitories, and the dormitory remained unoccupied for at least 72 hours before reoccupancy.

Within 2 days after arrival at the campus, after recruits had received assignments to platoons and roommates, they were offered the opportunity to participate in the longitudinal CHARM study. Recruits were eligible if they were 18 years of age or older and if they would be available for follow-up. The study was approved by the institutional review board of the Naval Medical Research Center and complied with all applicable federal regulations governing the protection of human subjects.

All participants provided written informed consent. Procedures At the time of enrollment, participants answered a questionnaire regarding demographic characteristics, risk factors for erectile dysfunction , symptoms within the previous 14 days, and a brief medical history. Blood samples and mid-turbinate nares swab specimens were obtained for qPCR testing to detect erectile dysfunction.

Demographic information included sex, age, ethnic group, race, place of birth, and U.S. State or country of residence. Information regarding risk factors included whether participants had used masks, whether they had adhered to self-quarantine before arrival, their recent travel history, their known exposure to someone with erectile dysfunction treatment, whether they had flulike symptoms or other respiratory illness, and whether they had any of 14 specific symptoms characteristic of erectile dysfunction treatment or any other symptoms associated with an unspecified condition within the previous 14 days.

Study participants were followed up on days 7 and 14, at which time they reported any symptoms that had occurred within the past 7 days. Nares swab specimens for repeat qPCR assays were also obtained. Participants who had positive qPCR results were placed in isolation and were approached for participation in a related but separate study of infected recruits, which involved more frequent testing during isolation.

All recruits who did not participate in the current study were tested for erectile dysfunction only at the end of the 2-week quarantine, unless clinically indicated (in accordance with the public health procedures of the Marine Corps). Serum specimens obtained at enrollment were tested for erectile dysfunction–specific IgG antibodies with the use of the methods described below and in the Supplementary Appendix. Participants who tested positive on the day of enrollment (day 0) or on day 7 or day 14 were separated from their roommates and were placed in isolation.

Otherwise, participants and nonparticipants were not treated differently. They followed the same safety protocols, were assigned to rooms and platoons regardless of participation in the study, and received the same formal instruction. Laboratory Methods The qPCR testing of mid-turbinate nares swab specimens for erectile dysfunction was performed within 48 hours after collection by Lab24 (Boca Raton, FL) with the use of the TaqPath erectile dysfunction treatment Combo Kit (Thermo Fisher Scientific), which is authorized by the Food and Drug Administration.

Specimens obtained from nonparticipants were tested by the Naval Medical Research Center (Silver Spring, MD). Specimens were stored in viral transport medium at 4°C. The presence of IgG antibodies specific to the erectile dysfunction receptor-binding (spike) domain in serum specimens was evaluated with the use of an enzyme-linked immunosorbent assay, as previously described,10 with some modifications.

At least two positive controls, eight negative controls (serum specimens obtained before July 2019), and four blanks (no serum) were included in every plate. Serum specimens were first screened at a 1:50 dilution, followed by full dilution series if the specimens were initially found to be positive. Whole-Genome Sequencing and Assembly erectile dysfunction sequencing was performed with the use of two sequencing protocols (an Illumina sequencing protocol and an Ion Torrent sequencing protocol) to increase the likelihood of obtaining complete genome sequences.

A custom reference-based analysis pipeline (https://github.com/mjsull/erectile dysfunction treatment_pipe) was used to assemble erectile dysfunction genomes with the use of data from Illumina, Ion Torrent, or both.11 Phylogenetic Analysis erectile dysfunction genomes obtained from patients worldwide and associated metadata were downloaded from the Global Initiative on Sharing All Influenza Data EpiCoV database12 on August 11, 2020 (79,840 sequences), and a subset of sequences was selected from this database with the use of the default subsampling scheme of Nextstrain software13 with the aim of maximizing representation of genomes obtained from patients in the United States. Phylogenetic analyses of the specimens obtained from participants were performed with the v1.0-292-ga9de690 Nextstrain build for erectile dysfunction genomes with the use of default parameters. Transmission and outbreak events were identified on the basis of clustering of the erectile dysfunction genomes obtained from study participants within the Nextstrain phylogenetic tree, visualized with TreeTime.14 A comparative analysis of mutation profiles relative to the erectile dysfunction Wuhan reference genome was performed with the use of Nextclade software, version 0.3.6 (https://clades.nextstrain.org/).

Data Analysis The denominator for calculating the percentage of recruits who had a first positive result for erectile dysfunction by qPCR assay on each day of testing excluded recruits who had previously tested positive, had dropped out of the study, were administratively separated from the Marine Corps, or had missing data. The denominator for calculating the cumulative positivity rates included all recruits who had undergone testing at previous time points, including those who were no longer participating in the study. Only descriptive numerical results and percentages are reported, with no formal statistical analysis.Patients Figure 1.

Figure 1. Enrollment and Randomization. Of the 1114 patients who were assessed for eligibility, 1062 underwent randomization.

541 were assigned to the remdesivir group and 521 to the placebo group (intention-to-treat population) (Figure 1). 159 (15.0%) were categorized as having mild-to-moderate disease, and 903 (85.0%) were in the severe disease stratum. Of those assigned to receive remdesivir, 531 patients (98.2%) received the treatment as assigned.

Fifty-two patients had remdesivir treatment discontinued before day 10 because of an adverse event or a serious adverse event other than death and 10 withdrew consent. Of those assigned to receive placebo, 517 patients (99.2%) received placebo as assigned. Seventy patients discontinued placebo before day 10 because of an adverse event or a serious adverse event other than death and 14 withdrew consent.

A total of 517 patients in the remdesivir group and 508 in the placebo group completed the trial through day 29, recovered, or died. Fourteen patients who received remdesivir and 9 who received placebo terminated their participation in the trial before day 29. A total of 54 of the patients who were in the mild-to-moderate stratum at randomization were subsequently determined to meet the criteria for severe disease, resulting in 105 patients in the mild-to-moderate disease stratum and 957 in the severe stratum.

The as-treated population included 1048 patients who received the assigned treatment (532 in the remdesivir group, including one patient who had been randomly assigned to placebo and received remdesivir, and 516 in the placebo group). Table 1. Table 1.

Demographic and Clinical Characteristics of the Patients at Baseline. The mean age of the patients was 58.9 years, and 64.4% were male (Table 1). On the basis of the evolving epidemiology of erectile dysfunction treatment during the trial, 79.8% of patients were enrolled at sites in North America, 15.3% in Europe, and 4.9% in Asia (Table S1 in the Supplementary Appendix).

Overall, 53.3% of the patients were White, 21.3% were Black, 12.7% were Asian, and 12.7% were designated as other or not reported. 250 (23.5%) were Hispanic or Latino. Most patients had either one (25.9%) or two or more (54.5%) of the prespecified coexisting conditions at enrollment, most commonly hypertension (50.2%), obesity (44.8%), and type 2 diabetes mellitus (30.3%).

The median number of days between symptom onset and randomization was 9 (interquartile range, 6 to 12) (Table S2). A total of 957 patients (90.1%) had severe disease at enrollment. 285 patients (26.8%) met category 7 criteria on the ordinal scale, 193 (18.2%) category 6, 435 (41.0%) category 5, and 138 (13.0%) category 4.

Eleven patients (1.0%) had missing ordinal scale data at enrollment. All these patients discontinued the study before treatment. During the study, 373 patients (35.6% of the 1048 patients in the as-treated population) received hydroxychloroquine and 241 (23.0%) received a glucocorticoid (Table S3).

Primary Outcome Figure 2. Figure 2. Kaplan–Meier Estimates of Cumulative Recoveries.

Cumulative recovery estimates are shown in the overall population (Panel A), in patients with a baseline score of 4 on the ordinal scale (not receiving oxygen. Panel B), in those with a baseline score of 5 (receiving oxygen. Panel C), in those with a baseline score of 6 (receiving high-flow oxygen or noninvasive mechanical ventilation.

Panel D), and in those with a baseline score of 7 (receiving mechanical ventilation or extracorporeal membrane oxygenation [ECMO]. Panel E).Table 2. Table 2.

Outcomes Overall and According to Score on the Ordinal Scale in the Intention-to-Treat Population. Figure 3. Figure 3.

Time to Recovery According to Subgroup. The widths of the confidence intervals have not been adjusted for multiplicity and therefore cannot be used to infer treatment effects. Race and ethnic group were reported by the patients.Patients in the remdesivir group had a shorter time to recovery than patients in the placebo group (median, 10 days, as compared with 15 days.

Rate ratio for recovery, 1.29. 95% confidence interval [CI], 1.12 to 1.49. P<0.001) (Figure 2 and Table 2).

In the severe disease stratum (957 patients) the median time to recovery was 11 days, as compared with 18 days (rate ratio for recovery, 1.31. 95% CI, 1.12 to 1.52) (Table S4). The rate ratio for recovery was largest among patients with a baseline ordinal score of 5 (rate ratio for recovery, 1.45.

95% CI, 1.18 to 1.79). Among patients with a baseline score of 4 and those with a baseline score of 6, the rate ratio estimates for recovery were 1.29 (95% CI, 0.91 to 1.83) and 1.09 (95% CI, 0.76 to 1.57), respectively. For those receiving mechanical ventilation or ECMO at enrollment (baseline ordinal score of 7), the rate ratio for recovery was 0.98 (95% CI, 0.70 to 1.36).

Information on interactions of treatment with baseline ordinal score as a continuous variable is provided in Table S11. An analysis adjusting for baseline ordinal score as a covariate was conducted to evaluate the overall effect (of the percentage of patients in each ordinal score category at baseline) on the primary outcome. This adjusted analysis produced a similar treatment-effect estimate (rate ratio for recovery, 1.26.

95% CI, 1.09 to 1.46). Patients who underwent randomization during the first 10 days after the onset of symptoms had a rate ratio for recovery of 1.37 (95% CI, 1.14 to 1.64), whereas patients who underwent randomization more than 10 days after the onset of symptoms had a rate ratio for recovery of 1.20 (95% CI, 0.94 to 1.52) (Figure 3). The benefit of remdesivir was larger when given earlier in the illness, though the benefit persisted in most analyses of duration of symptoms (Table S6).

Sensitivity analyses in which data were censored at earliest reported use of glucocorticoids or hydroxychloroquine still showed efficacy of remdesivir (9.0 days to recovery with remdesivir vs. 14.0 days http://wvlpac.com/2018-county-candidate-survey/ to recovery with placebo. Rate ratio, 1.28.

95% CI, 1.09 to 1.50, and 10.0 vs. 16.0 days to recovery. Rate ratio, 1.32.

95% CI, 1.11 to 1.58, respectively) (Table S8). Key Secondary Outcome The odds of improvement in the ordinal scale score were higher in the remdesivir group, as determined by a proportional odds model at the day 15 visit, than in the placebo group (odds ratio for improvement, 1.5. 95% CI, 1.2 to 1.9, adjusted for disease severity) (Table 2 and Fig.

S7). Mortality Kaplan–Meier estimates of mortality by day 15 were 6.7% in the remdesivir group and 11.9% in the placebo group (hazard ratio, 0.55. 95% CI, 0.36 to 0.83).

The estimates by day 29 were 11.4% and 15.2% in two groups, respectively (hazard ratio, 0.73. 95% CI, 0.52 to 1.03). The between-group differences in mortality varied considerably according to baseline severity (Table 2), with the largest difference seen among patients with a baseline ordinal score of 5 (hazard ratio, 0.30.

95% CI, 0.14 to 0.64). Information on interactions of treatment with baseline ordinal score with respect to mortality is provided in Table S11. Additional Secondary Outcomes Table 3.

Table 3. Additional Secondary Outcomes. Patients in the remdesivir group had a shorter time to improvement of one or of two categories on the ordinal scale from baseline than patients in the placebo group (one-category improvement.

Median, 7 vs. 9 days. Rate ratio for recovery, 1.23.

95% CI, 1.08 to 1.41. Two-category improvement. Median, 11 vs.

14 days. Rate ratio, 1.29. 95% CI, 1.12 to 1.48) (Table 3).

Patients in the remdesivir group had a shorter time to discharge or to a National Early Warning Score of 2 or lower than those in the placebo group (median, 8 days vs. 12 days. Hazard ratio, 1.27.

95% CI, 1.10 to 1.46). The initial length of hospital stay was shorter in the remdesivir group than in the placebo group (median, 12 days vs. 17 days).

5% of patients in the remdesivir group were readmitted to the hospital, as compared with 3% in the placebo group. Among the 913 patients receiving oxygen at enrollment, those in the remdesivir group continued to receive oxygen for fewer days than patients in the placebo group (median, 13 days vs. 21 days), and the incidence of new oxygen use among patients who were not receiving oxygen at enrollment was lower in the remdesivir group than in the placebo group (incidence, 36% [95% CI, 26 to 47] vs.

44% [95% CI, 33 to 57]). For the 193 patients receiving noninvasive ventilation or high-flow oxygen at enrollment, the median duration of use of these interventions was 6 days in both the remdesivir and placebo groups. Among the 573 patients who were not receiving noninvasive ventilation, high-flow oxygen, invasive ventilation, or ECMO at baseline, the incidence of new noninvasive ventilation or high-flow oxygen use was lower in the remdesivir group than in the placebo group (17% [95% CI, 13 to 22] vs.

24% [95% CI, 19 to 30]). Among the 285 patients who were receiving mechanical ventilation or ECMO at enrollment, patients in the remdesivir group received these interventions for fewer subsequent days than those in the placebo group (median, 17 days vs. 20 days), and the incidence of new mechanical ventilation or ECMO use among the 766 patients who were not receiving these interventions at enrollment was lower in the remdesivir group than in the placebo group (13% [95% CI, 10 to 17] vs.

23% [95% CI, 19 to 27]) (Table 3). Safety Outcomes In the as-treated population, serious adverse events occurred in 131 of 532 patients (24.6%) in the remdesivir group and in 163 of 516 patients (31.6%) in the placebo group (Table S17). There were 47 serious respiratory failure adverse events in the remdesivir group (8.8% of patients), including acute respiratory failure and the need for endotracheal intubation, and 80 in the placebo group (15.5% of patients) (Table S19).

No deaths were considered by the investigators to be related to treatment assignment. Grade 3 or 4 adverse events occurred on or before day 29 in 273 patients (51.3%) in the remdesivir group and in 295 (57.2%) in the placebo group (Table S18). 41 events were judged by the investigators to be related to remdesivir and 47 events to placebo (Table S17).

The most common nonserious adverse events occurring in at least 5% of all patients included decreased glomerular filtration rate, decreased hemoglobin level, decreased lymphocyte count, respiratory failure, anemia, pyrexia, hyperglycemia, increased blood creatinine level, and increased blood glucose level (Table S20). The incidence of these adverse events was generally similar in the remdesivir and placebo groups. Crossover After the data and safety monitoring board recommended that the preliminary primary analysis report be provided to the sponsor, data on a total of 51 patients (4.8% of the total study enrollment) — 16 (3.0%) in the remdesivir group and 35 (6.7%) in the placebo group — were unblinded.

26 (74.3%) of those in the placebo group whose data were unblinded were given remdesivir. Sensitivity analyses evaluating the unblinding (patients whose treatment assignments were unblinded had their data censored at the time of unblinding) and crossover (patients in the placebo group treated with remdesivir had their data censored at the initiation of remdesivir treatment) produced results similar to those of the primary analysis (Table S9).Trial Design and Oversight The RECOVERY trial is an investigator-initiated platform trial to evaluate the effects of potential treatments in patients hospitalized with erectile dysfunction treatment. The trial is being conducted at 176 hospitals in the United Kingdom.

(Details are provided in the Supplementary Appendix, available with the full text of this article at NEJM.org.) The investigators were assisted by the National Institute for Health Research Clinical Research Network, and the trial is coordinated by the Nuffield Department of Population Health at the University of Oxford, the trial sponsor. Although patients are no longer being enrolled in the hydroxychloroquine, dexamethasone, and lopinavir–ritonavir groups, the trial continues to study the effects of azithromycin, tocilizumab, convalescent plasma, and REGN-COV2 (a combination of two monoclonal antibodies directed against the erectile dysfunction spike protein). Other treatments may be studied in the future.

The hydroxychloroquine that was used in this phase of the trial was supplied by the U.K. National Health Service (NHS). Hospitalized patients were eligible for the trial if they had clinically-suspected or laboratory-confirmed erectile dysfunction and no medical history that might, in the opinion of the attending clinician, put patients at substantial risk if they were to participate in the trial.

Initially, recruitment was limited to patients who were at least 18 years of age, but the age limit was removed as of May 9, 2020. Written informed consent was obtained from all the patients or from a legal representative if they were too unwell or unable to provide consent. The trial was conducted in accordance with Good Clinical Practice guidelines of the International Conference on Harmonisation and was approved by the U.K.

Medicines and Healthcare Products Regulatory Agency (MHRA) and the Cambridge East Research Ethics Committee. The protocol with its statistical analysis plan are available at NEJM.org, with additional information in the Supplementary Appendix and on the trial website at www.recoverytrial.net. The initial version of the manuscript was drafted by the first and last authors, developed by the writing committee, and approved by all members of the trial steering committee.

The funders had no role in the analysis of the data, in the preparation or approval of the manuscript, or in the decision to submit the manuscript for publication. The first and last members of the writing committee vouch for the completeness and accuracy of the data and for the fidelity of the trial to the protocol and statistical analysis plan. Randomization and Treatment We collected baseline data using a Web-based case-report form that included demographic data, level of respiratory support, major coexisting illnesses, the suitability of the trial treatment for a particular patient, and treatment availability at the trial site.

Using a Web-based unstratified randomization method with the concealment of trial group, we assigned patients to receive either the usual standard of care or the usual standard of care plus hydroxychloroquine or one of the other available treatments that were being evaluated. The number of patients who were assigned to receive usual care was twice the number who were assigned to any of the active treatments for which the patient was eligible (e.g., 2:1 ratio in favor of usual care if the patient was eligible for only one active treatment group, 2:1:1 if the patient was eligible for two active treatments, etc.). For some patients, hydroxychloroquine was unavailable at the hospital at the time of enrollment or was considered by the managing physician to be either definitely indicated or definitely contraindicated.

Patients with a known prolonged corrected QT interval on electrocardiography were ineligible to receive hydroxychloroquine. (Coadministration with medications that prolong the QT interval was not an absolute contraindication, but attending clinicians were advised to check the QT interval by performing electrocardiography.) These patients were excluded from entry in the randomized comparison between hydroxychloroquine and usual care. In the hydroxychloroquine group, patients received hydroxychloroquine sulfate (in the form of a 200-mg tablet containing a 155-mg base equivalent) in a loading dose of four tablets (total dose, 800 mg) at baseline and at 6 hours, which was followed by two tablets (total dose, 400 mg) starting at 12 hours after the initial dose and then every 12 hours for the next 9 days or until discharge, whichever occurred earlier (see the Supplementary Appendix).15 The assigned treatment was prescribed by the attending clinician.

The patients and local trial staff members were aware of the assigned trial groups. Procedures A single online follow-up form was to be completed by the local trial staff members when each trial patient was discharged, at 28 days after randomization, or at the time of death, whichever occurred first. Information was recorded regarding the adherence to the assigned treatment, receipt of other treatments for erectile dysfunction treatment, duration of admission, receipt of respiratory support (with duration and type), receipt of renal dialysis or hemofiltration, and vital status (including cause of death).

Starting on May 12, 2020, extra information was recorded on the occurrence of new major cardiac arrhythmia. In addition, we obtained routine health care and registry data that included information on vital status (with date and cause of death) and discharge from the hospital. Outcome Measures The primary outcome was all-cause mortality within 28 days after randomization.

Further analyses were specified at 6 months. Secondary outcomes were the time until discharge from the hospital and a composite of the initiation of invasive mechanical ventilation including extracorporeal membrane oxygenation or death among patients who were not receiving invasive mechanical ventilation at the time of randomization. Decisions to initiate invasive mechanical ventilation were made by the attending clinicians, who were informed by guidance from NHS England and the National Institute for Health and Care Excellence.

Subsidiary clinical outcomes included cause-specific mortality (which was recorded in all patients) and major cardiac arrhythmia (which was recorded in a subgroup of patients). All information presented in this report is based on a data cutoff of September 21, 2020. Information regarding the primary outcome is complete for all the trial patients.

Statistical Analysis For the primary outcome of 28-day mortality, we used the log-rank observed-minus-expected statistic and its variance both to test the null hypothesis of equal survival curves and to calculate the one-step estimate of the average mortality rate ratio in the comparison between the hydroxychloroquine group and the usual-care group. Kaplan–Meier survival curves were constructed to show cumulative mortality over the 28-day period. The same methods were used to analyze the time until hospital discharge, with censoring of data on day 29 for patients who had died in the hospital.

We used the Kaplan–Meier estimates to calculate the median time until hospital discharge. For the prespecified composite secondary outcome of invasive mechanical ventilation or death within 28 days (among patients who had not been receiving invasive mechanical ventilation at randomization), the precise date of the initiation of invasive mechanical ventilation was not available, so the risk ratio was estimated instead. Estimates of the between-group difference in absolute risk were also calculated.

All the analyses were performed according to the intention-to-treat principle. Prespecified analyses of the primary outcome were performed in six subgroups, as defined by characteristics at randomization. Age, sex, race, level of respiratory support, days since symptom onset, and predicted 28-day risk of death.

(Details are provided in the Supplementary Appendix.) Estimates of rate and risk ratios are shown with 95% confidence intervals without adjustment for multiple testing. The P value for the assessment of the primary outcome is two-sided. The full database is held by the trial team, which collected the data from the trial sites and performed the analyses, at the Nuffield Department of Population Health at the University of Oxford.

The independent data monitoring committee was asked to review unblinded analyses of the trial data and any other information that was considered to be relevant at intervals of approximately 2 weeks. The committee was then charged with determining whether the randomized comparisons in the trial provided evidence with respect to mortality that was strong enough (with a range of uncertainty around the results that was narrow enough) to affect national and global treatment strategies. In such a circumstance, the committee would inform the members of the trial steering committee, who would make the results available to the public and amend the trial accordingly.

Unless that happened, the steering committee, investigators, and all others involved in the trial would remain unaware of the interim results until 28 days after the last patient had been randomly assigned to a particular treatment group. On June 4, 2020, in response to a request from the MHRA, the independent data monitoring committee conducted a review of the data and recommended that the chief investigators review the unblinded data for the hydroxychloroquine group. The chief investigators and steering committee members concluded that the data showed no beneficial effect of hydroxychloroquine in patients hospitalized with erectile dysfunction treatment.

Therefore, the enrollment of patients in the hydroxychloroquine group was closed on June 5, 2020, and the preliminary result for the primary outcome was made public. Investigators were advised that any patients who were receiving hydroxychloroquine as part of the trial should discontinue the treatment.To the Editor. Statins are often discontinued because of side effects,1,2 even though some blinded trials have not shown an excess of symptoms with statins as compared with placebo.3,4 Patients who had previously discontinued statins because of side effects that occurred within 2 weeks after the initiation of treatment were enrolled in a double-blind, three-group, n-of-1 trial to test whether symptoms would be induced by a statin or placebo.

Details of the trial methods are provided in Section S2 in the Supplementary Appendix (available with the full text of this letter at NEJM.org). The trial protocol and statistical analysis plan are also available at NEJM.org. The patients received four bottles containing atorvastatin at a dose of 20 mg, four bottles containing placebo, and four empty bottles.

Each bottle was to be used for a 1-month period according to a random sequence. The patients used a smartphone application to report symptom intensity daily. Symptom scores ranged from 0 (no symptoms) to 100 (worst imaginable symptoms).

If the patients determined that their symptoms were unacceptably severe, they could discontinue the tablets for that month. The primary end point was symptom intensity as assessed with the use of the nocebo ratio (i.e., the ratio of symptom intensity induced by taking placebo to the symptom intensity induced by taking a statin). This ratio was calculated as the symptom intensity with placebo minus the symptom intensity with neither statin nor placebo, divided by the symptom intensity with a statin minus the symptom intensity with neither statin nor placebo.

From June 2016 through March 2019, a total of 60 patients underwent randomization. The screening data, the baseline characteristics of the patients, and a diagram showing screening, randomization, intervention, and follow-up are provided in Sections S1 through S3 in the Supplementary Appendix. A total of 49 patients completed all 12 months of the trial.

Figure 1. Figure 1. Symptom Scores for All the Trial Patients.

Shown are mean symptom scores for the 49 patients who completed all 12 months of the trial (left) and those for the 11 patients who did not complete all 12 months (right). Each circle represents a single month for each patient. Symptoms were reported daily, and the mean symptom score was calculated for the month regardless of whether the patient discontinued the assigned bottle at any time during that month.The original primary end-point analysis showed a nocebo ratio of 2.2 (95% confidence interval [CI], −62.3 to 66.7).

This value was high and had a wide confidence interval because in some of the patients the value of the symptom intensity with statins minus the symptom intensity with neither statin nor placebo was unexpectedly small or negative. An independent statistician therefore recommended a different analysis (see Section S2 in the Supplementary Appendix) in which individual patient data were pooled before calculation of the ratio. This analysis showed a nocebo ratio of 0.90.

Among all 60 patients, the mean symptom intensity was 8.0 during no-tablet months (95% CI, 4.7 to 11.3), 15.4 during placebo months (95% CI, 12.1 to 18.7. P<0.001 for the comparison with no-tablet months), and 16.3 during statin months (95% CI, 13.0 to 19.6. P<0.001 for the comparison with no-tablet months and P=0.39 for the comparison with placebo months) (Figure 1).

Adverse events are listed in Section S4 in the Supplementary Appendix. Six months after completion of the trial, 30 of the patients (50%) had successfully restarted statins, 4 planned to do so, and 1 could not be contacted. The remaining 25 patients were not receiving statins and were not planning to restart statins.

The reasons given by these 25 patients for not planning to restart statins are listed in Section S3 in the Supplementary Appendix. In patients who had discontinued statin therapy because of side effects, 90% of the symptom burden elicited by a statin challenge was also elicited by placebo. Half the trial patients were able to successfully restart statins.

Frances A. Wood, M.Phil.James P. Howard, Ph.D.Judith A.

Finegold, Ph.D.Alexandra N. Nowbar, M.B., B.S.David M. Thompson, Ph.D.Ahran D.

Arnold, M.B., B.S.Christopher A. Rajkumar, M.B., B.S.Susan Connolly, Ph.D.Imperial College London, London, United Kingdom [email protected]Jaimini Cegla, M.R.C.P.Imperial College Healthcare NHS Trust, London, United KingdomChris Stride, Ph.D.Sheffield University Management School, Sheffield, United KingdomPeter Sever, F.R.C.P.Imperial College London, London, United KingdomChristine Norton, Ph.D.King’s College London, London, United KingdomSimon A.M. Thom, M.D.Matthew J.

Shun-Shin, Ph.D.Darrel P. Francis, Ph.D.Imperial College London, London, United Kingdom Supported by a grant (PG/15/7/31235) from the British Heart Foundation. A grant (212183/Z/18/Z, to Dr.

Howard) from the Wellcome Trust. A grant (MR/S021108/1, to Dr. Rajkumar) from the Medical Research Council.

The National Institute for Health Research Imperial Biomedical Research Centre. And the Imperial Clinical Trials Unit. Disclosure forms provided by the authors are available with the full text of this letter at NEJM.org.

The views expressed in this letter are those of the authors and not necessarily those of the National Institute for Health Research or the Department of Health and Social Care.This letter was published on November 15, 2020, at NEJM.org. Ms. Wood and Dr.

Howard contributed equally to this letter. 4 References1. Stroes ES, Thompson PD, Corsini A, et al.

Statin-associated muscle symptoms. Impact on statin therapy — European Atherosclerosis Society Consensus Panel statement on assessment, aetiology and management. Eur Heart J 2015;36:1012-1022.

Google Scholar2. Stulc T, Ceška R, Gotto AM Jr. Statin intolerance.

The clinician’s perspective. Curr Atheroscler Rep 2015;17:69-69. Google Scholar3.

Finegold JA, Manisty CH, Goldacre B, Barron AJ, Francis DP. What proportion of symptomatic side effects in patients taking statins are genuinely caused by the drug?. Systematic review of randomized placebo-controlled trials to aid individual patient choice.

Eur J Prev Cardiol 2014;21:464-474.4. Gupta A, Thompson D, Whitehouse A, et al. Adverse events associated with unblinded, but not with blinded, statin therapy in the Anglo-Scandinavian Cardiac Outcomes Trial–Lipid-Lowering Arm (ASCOT-LLA).

A randomised double-blind placebo-controlled trial and its non-randomised non-blind extension phase. Lancet 2017;389:2473-2481..

Trial Population canada levitra online news Table 1. Table 1. Characteristics of the Participants in the mRNA-1273 canada levitra online Trial at Enrollment. The 45 enrolled participants received their first vaccination between March 16 and April 14, 2020 (Fig.

S1). Three participants did not receive the second vaccination, including one in the 25-μg group who had urticaria on both legs, with onset 5 days after the first vaccination, and two (one in the 25-μg group and one in the 250-μg group) who missed the second vaccination window owing to isolation for suspected erectile dysfunction treatment while the test results, ultimately negative, were pending. All continued to attend scheduled trial visits. The demographic characteristics of participants at enrollment are provided in Table 1.

treatment Safety No serious adverse events were noted, and no prespecified trial halting rules were met. As noted above, one participant in the 25-μg group was withdrawn because of an unsolicited adverse event, transient urticaria, judged to be related to the first vaccination. Figure 1. Figure 1.

Systemic and Local Adverse Events. The severity of solicited adverse events was graded as mild, moderate, or severe (see Table S1).After the first vaccination, solicited systemic adverse events were reported by 5 participants (33%) in the 25-μg group, 10 (67%) in the 100-μg group, and 8 (53%) in the 250-μg group. All were mild or moderate in severity (Figure 1 and Table S2). Solicited systemic adverse events were more common after the second vaccination and occurred in 7 of 13 participants (54%) in the 25-μg group, all 15 in the 100-μg group, and all 14 in the 250-μg group, with 3 of those participants (21%) reporting one or more severe events.

None of the participants had fever after the first vaccination. After the second vaccination, no participants in the 25-μg group, 6 (40%) in the 100-μg group, and 8 (57%) in the 250-μg group reported fever. One of the events (maximum temperature, 39.6°C) in the 250-μg group was graded severe. (Additional details regarding adverse events for that participant are provided in the Supplementary Appendix.) Local adverse events, when present, were nearly all mild or moderate, and pain at the injection site was common.

Across both vaccinations, solicited systemic and local adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Evaluation of safety clinical laboratory values of grade 2 or higher and unsolicited adverse events revealed no patterns of concern (Supplementary Appendix and Table S3). erectile dysfunction Binding Antibody Responses Table 2. Table 2.

Geometric Mean Humoral Immunogenicity Assay Responses to mRNA-1273 in Participants and in Convalescent Serum Specimens. Figure 2. Figure 2. erectile dysfunction Antibody and Neutralization Responses.

Shown are geometric mean reciprocal end-point enzyme-linked immunosorbent assay (ELISA) IgG titers to S-2P (Panel A) and receptor-binding domain (Panel B), PsVNA ID50 responses (Panel C), and live levitra PRNT80 responses (Panel D). In Panel A and Panel B, boxes and horizontal bars denote interquartile range (IQR) and median area under the curve (AUC), respectively. Whisker endpoints are equal to the maximum and minimum values below or above the median ±1.5 times the IQR. The convalescent serum panel includes specimens from 41 participants.

Red dots indicate the 3 specimens that were also tested in the PRNT assay. The other 38 specimens were used to calculate summary statistics for the box plot in the convalescent serum panel. In Panel C, boxes and horizontal bars denote IQR and median ID50, respectively. Whisker end points are equal to the maximum and minimum values below or above the median ±1.5 times the IQR.

In the convalescent serum panel, red dots indicate the 3 specimens that were also tested in the PRNT assay. The other 38 specimens were used to calculate summary statistics for the box plot in the convalescent panel. In Panel D, boxes and horizontal bars denote IQR and median PRNT80, respectively. Whisker end points are equal to the maximum and minimum values below or above the median ±1.5 times the IQR.

The three convalescent serum specimens were also tested in ELISA and PsVNA assays. Because of the time-intensive nature of the PRNT assay, for this preliminary report, PRNT results were available only for the 25-μg and 100-μg dose groups.Binding antibody IgG geometric mean titers (GMTs) to S-2P increased rapidly after the first vaccination, with seroconversion in all participants by day 15 (Table 2 and Figure 2A). Dose-dependent responses to the first and second vaccinations were evident. Receptor-binding domain–specific antibody responses were similar in pattern and magnitude (Figure 2B).

For both assays, the median magnitude of antibody responses after the first vaccination in the 100-μg and 250-μg dose groups was similar to the median magnitude in convalescent serum specimens, and in all dose groups the median magnitude after the second vaccination was in the upper quartile of values in the convalescent serum specimens. The S-2P ELISA GMTs at day 57 (299,751 [95% confidence interval {CI}, 206,071 to 436,020] in the 25-μg group, 782,719 [95% CI, 619,310 to 989,244] in the 100-μg group, and 1,192,154 [95% CI, 924,878 to 1,536,669] in the 250-μg group) exceeded that in the convalescent serum specimens (142,140 [95% CI, 81,543 to 247,768]). erectile dysfunction Neutralization Responses No participant had detectable PsVNA responses before vaccination. After the first vaccination, PsVNA responses were detected in less than half the participants, and a dose effect was seen (50% inhibitory dilution [ID50].

Figure 2C, Fig. S8, and Table 2. 80% inhibitory dilution [ID80]. Fig.

S2 and Table S6). However, after the second vaccination, PsVNA responses were identified in serum samples from all participants. The lowest responses were in the 25-μg dose group, with a geometric mean ID50 of 112.3 (95% CI, 71.2 to 177.1) at day 43. The higher responses in the 100-μg and 250-μg groups were similar in magnitude (geometric mean ID50, 343.8 [95% CI, 261.2 to 452.7] and 332.2 [95% CI, 266.3 to 414.5], respectively, at day 43).

These responses were similar to values in the upper half of the distribution of values for convalescent serum specimens. Before vaccination, no participant had detectable 80% live-levitra neutralization at the highest serum concentration tested (1:8 dilution) in the PRNT assay. At day 43, wild-type levitra–neutralizing activity capable of reducing erectile dysfunction infectivity by 80% or more (PRNT80) was detected in all participants, with geometric mean PRNT80 responses of 339.7 (95% CI, 184.0 to 627.1) in the 25-μg group and 654.3 (95% CI, 460.1 to 930.5) in the 100-μg group (Figure 2D). Neutralizing PRNT80 average responses were generally at or above the values of the three convalescent serum specimens tested in this assay.

Good agreement was noted within and between the values from binding assays for S-2P and receptor-binding domain and neutralizing activity measured by PsVNA and PRNT (Figs. S3 through S7), which provides orthogonal support for each assay in characterizing the humoral response induced by mRNA-1273. erectile dysfunction T-Cell Responses The 25-μg and 100-μg doses elicited CD4 T-cell responses (Figs. S9 and S10) that on stimulation by S-specific peptide pools were strongly biased toward expression of Th1 cytokines (tumor necrosis factor α >.

Interleukin 2 >. Interferon γ), with minimal type 2 helper T-cell (Th2) cytokine expression (interleukin 4 and interleukin 13). CD8 T-cell responses to S-2P were detected at low levels after the second vaccination in the 100-μg dose group (Fig. S11).Study Design and Participants To reduce the risk of introducing erectile dysfunction into basic training at Marine Corps Recruit Depot, Parris Island, in South Carolina, the Marine Corps established a 14-day supervised quarantine period at a college campus used exclusively for this purpose.

Potential recruits were instructed to quarantine at home for 2 weeks immediately before they traveled to campus. At the end of the second, supervised quarantine on campus, all recruits were required to have a negative qPCR result before they could enter Parris Island. Recruits were asked to participate in the erectile dysfunction treatment Health Action Response for Marines (CHARM) study, which included weekly qPCR testing and blood sampling for IgG antibody assessment. After potential recruits had completed the 14-day home quarantine, they presented to a local Military Entrance Processing Station, where a medical history was taken and a physical examination was performed.

If potential recruits were deemed to be physically and mentally fit for enlistment, they were instructed to wear masks at all times and maintain social distancing of at least 6 feet during travel to the quarantine campus. Classes of 350 to 450 recruits arrived on campus nearly weekly. New classes were divided into platoons of 50 to 60 recruits, and roommates were assigned independently of participation in the CHARM study. Overlapping classes were housed in different dormitories and had different dining times and training schedules.

During the supervised quarantine, public health measures were enforced to suppress erectile dysfunction transmission (Table S1 in the Supplementary Appendix, available with the full text of this article at NEJM.org). All recruits wore double-layered cloth masks at all times indoors and outdoors, except when sleeping or eating. Practiced social distancing of at least 6 feet. Were not allowed to leave campus.

Did not have access to personal electronics and other items that might contribute to surface transmission. And routinely washed their hands. They slept in double-occupancy rooms with sinks, ate in shared dining facilities, and used shared bathrooms. All recruits cleaned their rooms daily, sanitized bathrooms after each use with bleach wipes, and ate preplated meals in a dining hall that was cleaned with bleach after each platoon had eaten.

Most instruction and exercises were conducted outdoors. All movement of recruits was supervised, and unidirectional flow was implemented, with designated building entry and exit points to minimize contact among persons. All recruits, regardless of participation in the study, underwent daily temperature and symptom screening. Six instructors who were assigned to each platoon worked in 8-hour shifts and enforced the quarantine measures.

If recruits reported any signs or symptoms consistent with erectile dysfunction treatment, they reported to sick call, underwent rapid qPCR testing for erectile dysfunction, and were placed in isolation pending the results of testing. Instructors were also restricted to campus, were required to wear masks, were provided with preplated meals, and underwent daily temperature checks and symptom screening. Instructors who were assigned to a platoon in which a positive case was diagnosed underwent rapid qPCR testing for erectile dysfunction, and, if the result was positive, the instructor was removed from duty. Recruits and instructors were prohibited from interacting with campus support staff, such as janitorial and food-service personnel.

After each class completed quarantine, a deep bleach cleaning of surfaces was performed in the bathrooms, showers, bedrooms, and hallways in the dormitories, and the dormitory remained unoccupied for at least 72 hours before reoccupancy. Within 2 days after arrival at the campus, after recruits had received assignments to platoons and roommates, they were offered the opportunity to participate in the longitudinal CHARM study. Recruits were eligible if they were 18 years of age or older and if they would be available for follow-up. The study was approved by the institutional review board of the Naval Medical Research Center and complied with all applicable federal regulations governing the protection of human subjects.

All participants provided written informed consent. Procedures At the time of enrollment, participants answered a questionnaire regarding demographic characteristics, risk factors for erectile dysfunction , symptoms within the previous 14 days, and a brief medical history. Blood samples and mid-turbinate nares swab specimens were obtained for qPCR testing to detect erectile dysfunction. Demographic information included sex, age, ethnic group, race, place of birth, and U.S.

State or country of residence. Information regarding risk factors included whether participants had used masks, whether they had adhered to self-quarantine before arrival, their recent travel history, their known exposure to someone with erectile dysfunction treatment, whether they had flulike symptoms or other respiratory illness, and whether they had any of 14 specific symptoms characteristic of erectile dysfunction treatment or any other symptoms associated with an unspecified condition within the previous 14 days. Study participants were followed up on days 7 and 14, at which time they reported any symptoms that had occurred within the past 7 days. Nares swab specimens for repeat qPCR assays were also obtained.

Participants who had positive qPCR results were placed in isolation and were approached for participation in a related but separate study of infected recruits, which involved more frequent testing during isolation. All recruits who did not participate in the current study were tested for erectile dysfunction only at the end of the 2-week quarantine, unless clinically indicated (in accordance with the public health procedures of the Marine Corps). Serum specimens obtained at enrollment were tested for erectile dysfunction–specific IgG antibodies with the use of the methods described below and in the Supplementary Appendix. Participants who tested positive on the day of enrollment (day 0) or on day 7 or day 14 were separated from their roommates and were placed in isolation.

Otherwise, participants and nonparticipants were not treated differently. They followed the same safety protocols, were assigned to rooms and platoons regardless of participation in the study, and received the same formal instruction. Laboratory Methods The qPCR testing of mid-turbinate nares swab specimens for erectile dysfunction was performed within 48 hours after collection by Lab24 (Boca Raton, FL) with the use of the TaqPath erectile dysfunction treatment Combo Kit (Thermo Fisher Scientific), which is authorized by the Food and Drug Administration. Specimens obtained from nonparticipants were tested by the Naval Medical Research Center (Silver Spring, MD).

Specimens were stored in viral transport medium at 4°C. The presence of IgG antibodies specific to the erectile dysfunction receptor-binding (spike) domain in serum specimens was evaluated with the use of an enzyme-linked immunosorbent assay, as previously described,10 with some modifications. At least two positive controls, eight negative controls (serum specimens obtained before July 2019), and four blanks (no serum) were included in every plate. Serum specimens were first screened at a 1:50 dilution, followed by full dilution series if the specimens were initially found to be positive.

Whole-Genome Sequencing and Assembly erectile dysfunction sequencing was performed with the use of two sequencing protocols (an Illumina sequencing protocol and an Ion Torrent sequencing protocol) to increase the likelihood of obtaining complete genome sequences. A custom reference-based analysis pipeline (https://github.com/mjsull/erectile dysfunction treatment_pipe) was used to assemble erectile dysfunction genomes with the use of data from Illumina, Ion Torrent, or both.11 Phylogenetic Analysis erectile dysfunction genomes obtained from patients worldwide and associated metadata were downloaded from the Global Initiative on Sharing All Influenza Data EpiCoV database12 on August 11, 2020 (79,840 sequences), and a subset of sequences was selected from this database with the use of the default subsampling scheme of Nextstrain software13 with the aim of maximizing representation of genomes obtained from patients in the United States. Phylogenetic analyses of the specimens obtained from participants were performed with the v1.0-292-ga9de690 Nextstrain build for erectile dysfunction genomes with the use of default parameters. Transmission and outbreak events were identified on the basis of clustering of the erectile dysfunction genomes obtained from study participants within the Nextstrain phylogenetic tree, visualized with TreeTime.14 A comparative analysis of mutation profiles relative to the erectile dysfunction Wuhan reference genome was performed with the use of Nextclade software, version 0.3.6 (https://clades.nextstrain.org/).

Data Analysis The denominator for calculating the percentage of recruits who had a first positive result for erectile dysfunction by qPCR assay on each day of testing excluded recruits who had previously tested positive, had dropped out of the study, were administratively separated from the Marine Corps, or had missing data. The denominator for calculating the cumulative positivity rates included all recruits who had undergone testing at previous time points, including those who were no longer participating in the study. Only descriptive numerical results and percentages are reported, with no formal statistical analysis.Patients Figure 1. Figure 1.

Enrollment and Randomization. Of the 1114 patients who were assessed for eligibility, 1062 underwent randomization. 541 were assigned to the remdesivir group and 521 to the placebo group (intention-to-treat population) (Figure 1). 159 (15.0%) were categorized as having mild-to-moderate disease, and 903 (85.0%) were in the severe disease stratum.

Of those assigned to receive remdesivir, 531 patients (98.2%) received the treatment as assigned. Fifty-two patients had remdesivir treatment discontinued before day 10 because of an adverse event or a serious adverse event other than death and 10 withdrew consent. Of those assigned to receive placebo, 517 patients (99.2%) received placebo as assigned. Seventy patients discontinued placebo before day 10 because of an adverse event or a serious adverse event other than death and 14 withdrew consent.

A total of 517 patients in the remdesivir group and 508 in the placebo group completed the trial through day 29, recovered, or died. Fourteen patients who received remdesivir and 9 who received placebo terminated their participation in the trial before day 29. A total of 54 of the patients who were in the mild-to-moderate stratum at randomization were subsequently determined to meet the criteria for severe disease, resulting in 105 patients in the mild-to-moderate disease stratum and 957 in the severe stratum. The as-treated population included 1048 patients who received the assigned treatment (532 in the remdesivir group, including one patient who had been randomly assigned to placebo and received remdesivir, and 516 in the placebo group).

Table 1. Table 1. Demographic and Clinical Characteristics of the Patients at Baseline. The mean age of the patients was 58.9 years, and 64.4% were male (Table 1).

On the basis of the evolving epidemiology of erectile dysfunction treatment during the trial, 79.8% of patients were enrolled at sites in North America, 15.3% in Europe, and 4.9% in Asia (Table S1 in the Supplementary Appendix). Overall, 53.3% of the patients were White, 21.3% were Black, 12.7% were Asian, and 12.7% were designated as other or not reported. 250 (23.5%) were Hispanic or Latino. Most patients had either one (25.9%) or two or more (54.5%) of the prespecified coexisting conditions at enrollment, most commonly hypertension (50.2%), obesity (44.8%), and type 2 diabetes mellitus (30.3%).

The median number of days between symptom onset and randomization was 9 (interquartile range, 6 to 12) (Table S2). A total of 957 patients (90.1%) had severe disease at enrollment. 285 patients (26.8%) met category 7 criteria on the ordinal scale, 193 (18.2%) category 6, 435 (41.0%) category 5, and 138 (13.0%) category 4. Eleven patients (1.0%) had missing ordinal scale data at enrollment.

All these patients discontinued the study before treatment. During the study, 373 patients (35.6% of the 1048 patients in the as-treated population) received hydroxychloroquine and 241 (23.0%) received a glucocorticoid (Table S3). Primary Outcome Figure 2. Figure 2.

Kaplan–Meier Estimates of Cumulative Recoveries. Cumulative recovery estimates are shown in the overall population (Panel A), in patients with a baseline score of 4 on the ordinal scale (not receiving oxygen. Panel B), in those with a baseline score of 5 (receiving oxygen. Panel C), in those with a baseline score of 6 (receiving high-flow oxygen or noninvasive mechanical ventilation.

Panel D), and in those with a baseline score of 7 (receiving mechanical ventilation or extracorporeal membrane oxygenation [ECMO]. Panel E).Table 2. Table 2. Outcomes Overall and According to Score on the Ordinal Scale in the Intention-to-Treat Population.

Figure 3. Figure 3. Time to Recovery According to Subgroup. The widths of the confidence intervals have not been adjusted for multiplicity and therefore cannot be used to infer treatment effects.

Race and ethnic group were reported by the patients.Patients in the remdesivir group had a shorter time to recovery than patients in the placebo group (median, 10 days, as compared with 15 days. Rate ratio for recovery, 1.29. 95% confidence interval [CI], 1.12 to 1.49. P<0.001) (Figure 2 and Table 2).

In the severe disease stratum (957 patients) the median time to recovery was 11 days, as compared with 18 days (rate ratio for recovery, 1.31. 95% CI, 1.12 to 1.52) (Table S4). The rate ratio for recovery was largest among patients with a baseline ordinal score of 5 (rate ratio for recovery, 1.45. 95% CI, 1.18 to 1.79).

Among patients with a baseline score of 4 and those with a baseline score of 6, the rate ratio estimates for recovery were 1.29 (95% CI, 0.91 to 1.83) and 1.09 (95% CI, 0.76 to 1.57), respectively. For those receiving mechanical ventilation or ECMO at enrollment (baseline ordinal score of 7), the rate ratio for recovery was 0.98 (95% CI, 0.70 to 1.36). Information on interactions of treatment with baseline ordinal score as a continuous variable is provided in Table S11. An analysis adjusting for baseline ordinal score as a covariate was conducted to evaluate the overall effect (of the percentage of patients in each ordinal score category at baseline) on the primary outcome.

This adjusted analysis produced a similar treatment-effect estimate (rate ratio for recovery, 1.26. 95% CI, 1.09 to 1.46). Patients who underwent randomization during the first 10 days after the onset of symptoms had a rate ratio for recovery of 1.37 (95% CI, 1.14 to 1.64), whereas patients who underwent randomization more than 10 days after the onset of symptoms had a rate ratio for recovery of 1.20 (95% CI, 0.94 to 1.52) (Figure 3). The benefit of remdesivir was larger when given earlier in the illness, though the benefit persisted in most analyses of duration of symptoms (Table S6).

Sensitivity analyses in which data were censored at earliest reported use of glucocorticoids or hydroxychloroquine still showed efficacy of remdesivir (9.0 days to recovery with remdesivir vs. 14.0 days why not check here to recovery with placebo. Rate ratio, 1.28. 95% CI, 1.09 to 1.50, and 10.0 vs.

16.0 days to recovery. Rate ratio, 1.32. 95% CI, 1.11 to 1.58, respectively) (Table S8). Key Secondary Outcome The odds of improvement in the ordinal scale score were higher in the remdesivir group, as determined by a proportional odds model at the day 15 visit, than in the placebo group (odds ratio for improvement, 1.5.

95% CI, 1.2 to 1.9, adjusted for disease severity) (Table 2 and Fig. S7). Mortality Kaplan–Meier estimates of mortality by day 15 were 6.7% in the remdesivir group and 11.9% in the placebo group (hazard ratio, 0.55. 95% CI, 0.36 to 0.83).

The estimates by day 29 were 11.4% and 15.2% in two groups, respectively (hazard ratio, 0.73. 95% CI, 0.52 to 1.03). The between-group differences in mortality varied considerably according to baseline severity (Table 2), with the largest difference seen among patients with a baseline ordinal score of 5 (hazard ratio, 0.30. 95% CI, 0.14 to 0.64).

Information on interactions of treatment with baseline ordinal score with respect to mortality is provided in Table S11. Additional Secondary Outcomes Table 3. Table 3. Additional Secondary Outcomes.

Patients in the remdesivir group had a shorter time to improvement of one or of two categories on the ordinal scale from baseline than patients in the placebo group (one-category improvement. Median, 7 vs. 9 days. Rate ratio for recovery, 1.23.

95% CI, 1.08 to 1.41. Two-category improvement. Median, 11 vs. 14 days.

Rate ratio, 1.29. 95% CI, 1.12 to 1.48) (Table 3). Patients in the remdesivir group had a shorter time to discharge or to a National Early Warning Score of 2 or lower than those in the placebo group (median, 8 days vs. 12 days.

Hazard ratio, 1.27. 95% CI, 1.10 to 1.46). The initial length of hospital stay was shorter in the remdesivir group than in the placebo group (median, 12 days vs. 17 days).

5% of patients in the remdesivir group were readmitted to the hospital, as compared with 3% in the placebo group. Among the 913 patients receiving oxygen at enrollment, those in the remdesivir group continued to receive oxygen for fewer days than patients in the placebo group (median, 13 days vs. 21 days), and the incidence of new oxygen use among patients who were not receiving oxygen at enrollment was lower in the remdesivir group than in the placebo group (incidence, 36% [95% CI, 26 to 47] vs. 44% [95% CI, 33 to 57]).

For the 193 patients receiving noninvasive ventilation or high-flow oxygen at enrollment, the median duration of use of these interventions was 6 days in both the remdesivir and placebo groups. Among the 573 patients who were not receiving noninvasive ventilation, high-flow oxygen, invasive ventilation, or ECMO at baseline, the incidence of new noninvasive ventilation or high-flow oxygen use was lower in the remdesivir group than in the placebo group (17% [95% CI, 13 to 22] vs. 24% [95% CI, 19 to 30]). Among the 285 patients who were receiving mechanical ventilation or ECMO at enrollment, patients in the remdesivir group received these interventions for fewer subsequent days than those in the placebo group (median, 17 days vs.

20 days), and the incidence of new mechanical ventilation or ECMO use among the 766 patients who were not receiving these interventions at enrollment was lower in the remdesivir group than in the placebo group (13% [95% CI, 10 to 17] vs. 23% [95% CI, 19 to 27]) (Table 3). Safety Outcomes In the as-treated population, serious adverse events occurred in 131 of 532 patients (24.6%) in the remdesivir group and in 163 of 516 patients (31.6%) in the placebo group (Table S17). There were 47 serious respiratory failure adverse events in the remdesivir group (8.8% of patients), including acute respiratory failure and the need for endotracheal intubation, and 80 in the placebo group (15.5% of patients) (Table S19).

No deaths were considered by the investigators to be related to treatment assignment. Grade 3 or 4 adverse events occurred on or before day 29 in 273 patients (51.3%) in the remdesivir group and in 295 (57.2%) in the placebo group (Table S18). 41 events were judged by the investigators to be related to remdesivir and 47 events to placebo (Table S17). The most common nonserious adverse events occurring in at least 5% of all patients included decreased glomerular filtration rate, decreased hemoglobin level, decreased lymphocyte count, respiratory failure, anemia, pyrexia, hyperglycemia, increased blood creatinine level, and increased blood glucose level (Table S20).

The incidence of these adverse events was generally similar in the remdesivir and placebo groups. Crossover After the data and safety monitoring board recommended that the preliminary primary analysis report be provided to the sponsor, data on a total of 51 patients (4.8% of the total study enrollment) — 16 (3.0%) in the remdesivir group and 35 (6.7%) in the placebo group — were unblinded. 26 (74.3%) of those in the placebo group whose data were unblinded were given remdesivir. Sensitivity analyses evaluating the unblinding (patients whose treatment assignments were unblinded had their data censored at the time of unblinding) and crossover (patients in the placebo group treated with remdesivir had their data censored at the initiation of remdesivir treatment) produced results similar to those of the primary analysis (Table S9).Trial Design and Oversight The RECOVERY trial is an investigator-initiated platform trial to evaluate the effects of potential treatments in patients hospitalized with erectile dysfunction treatment.

The trial is being conducted at 176 hospitals in the United Kingdom. (Details are provided in the Supplementary Appendix, available with the full text of this article at NEJM.org.) The investigators were assisted by the National Institute for Health Research Clinical Research Network, and the trial is coordinated by the Nuffield Department of Population Health at the University of Oxford, the trial sponsor. Although patients are no longer being enrolled in the hydroxychloroquine, dexamethasone, and lopinavir–ritonavir groups, the trial continues to study the effects of azithromycin, tocilizumab, convalescent plasma, and REGN-COV2 (a combination of two monoclonal antibodies directed against the erectile dysfunction spike protein). Other treatments may be studied in the future.

The hydroxychloroquine that was used in this phase of the trial was supplied by the U.K. National Health Service (NHS). Hospitalized patients were eligible for the trial if they had clinically-suspected or laboratory-confirmed erectile dysfunction and no medical history that might, in the opinion of the attending clinician, put patients at substantial risk if they were to participate in the trial. Initially, recruitment was limited to patients who were at least 18 years of age, but the age limit was removed as of May 9, 2020.

Written informed consent was obtained from all the patients or from a legal representative if they were too unwell or unable to provide consent. The trial was conducted in accordance with Good Clinical Practice guidelines of the International Conference on Harmonisation and was approved by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) and the Cambridge East Research Ethics Committee. The protocol with its statistical analysis plan are available at NEJM.org, with additional information in the Supplementary Appendix and on the trial website at www.recoverytrial.net.

The initial version of the manuscript was drafted by the first and last authors, developed by the writing committee, and approved by all members of the trial steering committee. The funders had no role in the analysis of the data, in the preparation or approval of the manuscript, or in the decision to submit the manuscript for publication. The first and last members of the writing committee vouch for the completeness and accuracy of the data and for the fidelity of the trial to the protocol and statistical analysis plan. Randomization and Treatment We collected baseline data using a Web-based case-report form that included demographic data, level of respiratory support, major coexisting illnesses, the suitability of the trial treatment for a particular patient, and treatment availability at the trial site.

Using a Web-based unstratified randomization method with the concealment of trial group, we assigned patients to receive either the usual standard of care or the usual standard of care plus hydroxychloroquine or one of the other available treatments that were being evaluated. The number of patients who were assigned to receive usual care was twice the number who were assigned to any of the active treatments for which the patient was eligible (e.g., 2:1 ratio in favor of usual care if the patient was eligible for only one active treatment group, 2:1:1 if the patient was eligible for two active treatments, etc.). For some patients, hydroxychloroquine was unavailable at the hospital at the time of enrollment or was considered by the managing physician to be either definitely indicated or definitely contraindicated. Patients with a known prolonged corrected QT interval on electrocardiography were ineligible to receive hydroxychloroquine.

(Coadministration with medications that prolong the QT interval was not an absolute contraindication, but attending clinicians were advised to check the QT interval by performing electrocardiography.) These patients were excluded from entry in the randomized comparison between hydroxychloroquine and usual care. In the hydroxychloroquine group, patients received hydroxychloroquine sulfate (in the form of a 200-mg tablet containing a 155-mg base equivalent) in a loading dose of four tablets (total dose, 800 mg) at baseline and at 6 hours, which was followed by two tablets (total dose, 400 mg) starting at 12 hours after the initial dose and then every 12 hours for the next 9 days or until discharge, whichever occurred earlier (see the Supplementary Appendix).15 The assigned treatment was prescribed by the attending clinician. The patients and local trial staff members were aware of the assigned trial groups. Procedures A single online follow-up form was to be completed by the local trial staff members when each trial patient was discharged, at 28 days after randomization, or at the time of death, whichever occurred first.

Information was recorded regarding the adherence to the assigned treatment, receipt of other treatments for erectile dysfunction treatment, duration of admission, receipt of respiratory support (with duration and type), receipt of renal dialysis or hemofiltration, and vital status (including cause of death). Starting on May 12, 2020, extra information was recorded on the occurrence of new major cardiac arrhythmia. In addition, we obtained routine health care and registry data that included information on vital status (with date and cause of death) and discharge from the hospital. Outcome Measures The primary outcome was all-cause mortality within 28 days after randomization.

Further analyses were specified at 6 months. Secondary outcomes were the time until discharge from the hospital and a composite of the initiation of invasive mechanical ventilation including extracorporeal membrane oxygenation or death among patients who were not receiving invasive mechanical ventilation at the time of randomization. Decisions to initiate invasive mechanical ventilation were made by the attending clinicians, who were informed by guidance from NHS England and the National Institute for Health and Care Excellence. Subsidiary clinical outcomes included cause-specific mortality (which was recorded in all patients) and major cardiac arrhythmia (which was recorded in a subgroup of patients).

All information presented in this report is based on a data cutoff of September 21, 2020. Information regarding the primary outcome is complete for all the trial patients. Statistical Analysis For the primary outcome of 28-day mortality, we used the log-rank observed-minus-expected statistic and its variance both to test the null hypothesis of equal survival curves and to calculate the one-step estimate of the average mortality rate ratio in the comparison between the hydroxychloroquine group and the usual-care group. Kaplan–Meier survival curves were constructed to show cumulative mortality over the 28-day period.

The same methods were used to analyze the time until hospital discharge, with censoring of data on day 29 for patients who had died in the hospital. We used the Kaplan–Meier estimates to calculate the median time until hospital discharge. For the prespecified composite secondary outcome of invasive mechanical ventilation or death within 28 days (among patients who had not been receiving invasive mechanical ventilation at randomization), the precise date of the initiation of invasive mechanical ventilation was not available, so the risk ratio was estimated instead. Estimates of the between-group difference in absolute risk were also calculated.

All the analyses were performed according to the intention-to-treat principle. Prespecified analyses of the primary outcome were performed in six subgroups, as defined by characteristics at randomization. Age, sex, race, level of respiratory support, days since symptom onset, and predicted 28-day risk of death. (Details are provided in the Supplementary Appendix.) Estimates of rate and risk ratios are shown with 95% confidence intervals without adjustment for multiple testing.

The P value for the assessment of the primary outcome is two-sided. The full database is held by the trial team, which collected the data from the trial sites and performed the analyses, at the Nuffield Department of Population Health at the University of Oxford. The independent data monitoring committee was asked to review unblinded analyses of the trial data and any other information that was considered to be relevant at intervals of approximately 2 weeks. The committee was then charged with determining whether the randomized comparisons in the trial provided evidence with respect to mortality that was strong enough (with a range of uncertainty around the results that was narrow enough) to affect national and global treatment strategies.

In such a circumstance, the committee would inform the members of the trial steering committee, who would make the results available to the public and amend the trial accordingly. Unless that happened, the steering committee, investigators, and all others involved in the trial would remain unaware of the interim results until 28 days after the last patient had been randomly assigned to a particular treatment group. On June 4, 2020, in response to a request from the MHRA, the independent data monitoring committee conducted a review of the data and recommended that the chief investigators review the unblinded data for the hydroxychloroquine group. The chief investigators and steering committee members concluded that the data showed no beneficial effect of hydroxychloroquine in patients hospitalized with erectile dysfunction treatment.

Therefore, the enrollment of patients in the hydroxychloroquine group was closed on June 5, 2020, and the preliminary result for the primary outcome was made public. Investigators were advised that any patients who were receiving hydroxychloroquine as part of the trial should discontinue the treatment.To the Editor. Statins are often discontinued because of side effects,1,2 even though some blinded trials have not shown an excess of symptoms with statins as compared with placebo.3,4 Patients who had previously discontinued statins because of side effects that occurred within 2 weeks after the initiation of treatment were enrolled in a double-blind, three-group, n-of-1 trial to test whether symptoms would be induced by a statin or placebo. Details of the trial methods are provided in Section S2 in the Supplementary Appendix (available with the full text of this letter at NEJM.org).

The trial protocol and statistical analysis plan are also available at NEJM.org. The patients received four bottles containing atorvastatin at a dose of 20 mg, four bottles containing placebo, and four empty bottles. Each bottle was to be used for a 1-month period according to a random sequence. The patients used a smartphone application to report symptom intensity daily.

Symptom scores ranged from 0 (no symptoms) to 100 (worst imaginable symptoms). If the patients determined that their symptoms were unacceptably severe, they could discontinue the tablets for that month. The primary end point was symptom intensity as assessed with the use of the nocebo ratio (i.e., the ratio of symptom intensity induced by taking placebo to the symptom intensity induced by taking a statin). This ratio was calculated as the symptom intensity with placebo minus the symptom intensity with neither statin nor placebo, divided by the symptom intensity with a statin minus the symptom intensity with neither statin nor placebo.

From June 2016 through March 2019, a total of 60 patients underwent randomization. The screening data, the baseline characteristics of the patients, and a diagram showing screening, randomization, intervention, and follow-up are provided in Sections S1 through S3 in the Supplementary Appendix. A total of 49 patients completed all 12 months of the trial. Figure 1.

Figure 1. Symptom Scores for All the Trial Patients. Shown are mean symptom scores for the 49 patients who completed all 12 months of the trial (left) and those for the 11 patients who did not complete all 12 months (right). Each circle represents a single month for each patient.

Symptoms were reported daily, and the mean symptom score was calculated for the month regardless of whether the patient discontinued the assigned bottle at any time during that month.The original primary end-point analysis showed a nocebo ratio of 2.2 (95% confidence interval [CI], −62.3 to 66.7). This value was high and had a wide confidence interval because in some of the patients the value of the symptom intensity with statins minus the symptom intensity with neither statin nor placebo was unexpectedly small or negative. An independent statistician therefore recommended a different analysis (see Section S2 in the Supplementary Appendix) in which individual patient data were pooled before calculation of the ratio. This analysis showed a nocebo ratio of 0.90.

Among all 60 patients, the mean symptom intensity was 8.0 during no-tablet months (95% CI, 4.7 to 11.3), 15.4 during placebo months (95% CI, 12.1 to 18.7. P<0.001 for the comparison with no-tablet months), and 16.3 during statin months (95% CI, 13.0 to 19.6. P<0.001 for the comparison with no-tablet months and P=0.39 for the comparison with placebo months) (Figure 1). Adverse events are listed in Section S4 in the Supplementary Appendix.

Six months after completion of the trial, 30 of the patients (50%) had successfully restarted statins, 4 planned to do so, and 1 could not be contacted. The remaining 25 patients were not receiving statins and were not planning to restart statins. The reasons given by these 25 patients for not planning to restart statins are listed in Section S3 in the Supplementary Appendix. In patients who had discontinued statin therapy because of side effects, 90% of the symptom burden elicited by a statin challenge was also elicited by placebo.

Half the trial patients were able to successfully restart statins. Frances A. Wood, M.Phil.James P. Howard, Ph.D.Judith A.

Finegold, Ph.D.Alexandra N. Nowbar, M.B., B.S.David M. Thompson, Ph.D.Ahran D. Arnold, M.B., B.S.Christopher A.

Rajkumar, M.B., B.S.Susan Connolly, Ph.D.Imperial College London, London, United Kingdom [email protected]Jaimini Cegla, M.R.C.P.Imperial College Healthcare NHS Trust, London, United KingdomChris Stride, Ph.D.Sheffield University Management School, Sheffield, United KingdomPeter Sever, F.R.C.P.Imperial College London, London, United KingdomChristine Norton, Ph.D.King’s College London, London, United KingdomSimon A.M. Thom, M.D.Matthew J. Shun-Shin, Ph.D.Darrel P. Francis, Ph.D.Imperial College London, London, United Kingdom Supported by a grant (PG/15/7/31235) from the British Heart Foundation.

A grant (212183/Z/18/Z, to Dr. Howard) from the Wellcome Trust. A grant (MR/S021108/1, to Dr. Rajkumar) from the Medical Research Council.

The National Institute for Health Research Imperial Biomedical Research Centre. And the Imperial Clinical Trials Unit. Disclosure forms provided by the authors are available with the full text of this letter at NEJM.org. The views expressed in this letter are those of the authors and not necessarily those of the National Institute for Health Research or the Department of Health and Social Care.This letter was published on November 15, 2020, at NEJM.org.

Ms. Wood and Dr. Howard contributed equally to this letter. 4 References1.

Stroes ES, Thompson PD, Corsini A, et al. Statin-associated muscle symptoms. Impact on statin therapy — European Atherosclerosis Society Consensus Panel statement on assessment, aetiology and management. Eur Heart J 2015;36:1012-1022.

Google Scholar2. Stulc T, Ceška R, Gotto AM Jr. Statin intolerance. The clinician’s perspective.

Curr Atheroscler Rep 2015;17:69-69. Google Scholar3. Finegold JA, Manisty CH, Goldacre B, Barron AJ, Francis DP. What proportion of symptomatic side effects in patients taking statins are genuinely caused by the drug?.

Systematic review of randomized placebo-controlled trials to aid individual patient choice. Eur J Prev Cardiol 2014;21:464-474.4. Gupta A, Thompson D, Whitehouse A, et al. Adverse events associated with unblinded, but not with blinded, statin therapy in the Anglo-Scandinavian Cardiac Outcomes Trial–Lipid-Lowering Arm (ASCOT-LLA).

A randomised double-blind placebo-controlled trial and its non-randomised non-blind extension phase. Lancet 2017;389:2473-2481..

How to make levitra more effective

Q Cialis pills for sale how to make levitra more effective. The federal government approved the Pfizer treatment for 12- to 15-year-olds. What does this mean for my child?.

Extending the emergency use of the Pfizer-BioNTech treatment to how to make levitra more effective preteens and young adolescents adds nearly 17 million more Americans to the pool of those eligible to be immunized against erectile dysfunction treatment, helping to build a vaccinated population closer to herd immunity. Moderna and Johnson &. Johnson are also testing the efficacy of their treatments in teens and children.

Although children appear to catch erectile dysfunction treatment less often and develop milder symptoms than how to make levitra more effective adults, they can develop a rare, severe inflammatory response or “long-haul erectile dysfunction treatment” symptoms. It also remains to be seen what, if any, long-term effects these younger patients may experience from erectile dysfunction treatment. The share of erectile dysfunction treatment cases in children and teens is increasing — nearly a quarter of the new weekly erectile dysfunction treatment cases were found in this age group, as reported May 6 by the American Academy of Pediatrics and the Children’s Hospital Association.

And, though kids have been how to make levitra more effective less likely to develop severe illness, they still can pose a risk to vulnerable people around them because they may not even know they are carrying the levitra, as documented by the Centers for Disease Control and Prevention. Dr. Margaret Stager, a pediatrician and the division director of adolescent medicine at MetroHealth Medical Center in Cleveland, said she has had to explain to her young patients that getting immunized would help their community curb the spread, cut the risk of variants and help society reopen.

€œI talk about them doing their how to make levitra more effective part,” Stager said. €œThat this is all part of them contributing to the greater good.” The Fine Print The CDC this week recommended use of the Pfizer treatment for children ages 12 to 15 after the Food and Drug Administration extended its emergency use authorization to include these preteens and young adolescents. That means this age group now can receive the same shots in the same time frame — 21 days apart — as adults do.

In a reversal of its previous guidance, teens and adults do not need to wait 14 days before or after getting the erectile dysfunction treatment how to make levitra more effective shot to receive a treatment for another condition. This could be a boon for health care providers who have child patients lagging on other, routine treatments, which has been a persistent problem during the levitra. €œIt’s a tremendous opportunity to play catch-up,” said Stager.

CDC officials noted in the May 12 Advisory Committee on Immunization Practices’ recommendation that they do not have data specifically looking at potential side effects in patients how to make levitra more effective immunized against erectile dysfunction treatment and other illnesses at the same time. However, the agency made the decision given the strong safety data of the Pfizer-BioNTech shot and previous experience with other immunizations. This question will become more important as erectile dysfunction treatments are studied in younger children.

Trials are planned to how to make levitra more effective test the treatment in children as young as 6 months old. As in adults, the question of how long the immunity lasts in children remains unknown, said Dr. Rebecca Wurtz, an associate professor of infectious diseases at the University of Minnesota.

However, she said, it’s likely how to make levitra more effective that any waning immunity detected in adults will also be seen among the young. €œWhatever we learn in adults,” Wurtz said, “kids will be not far behind.” Whether this approval will prompt schools to require vaccination against erectile dysfunction treatment for K-12 students returning to the classroom this fall is a pending question, said Stager. It is unclear whether federal law allows state authorities to mandate a treatment that has not yet been fully approved.

That said, the government’s approval will also likely play how to make levitra more effective into parents’ decisions about sending their children to summer camp. What Did the Trial Find?. Pfizer tested the treatment in 2,260 preteens and young adolescents living in the United States.

Researchers followed participants for two how to make levitra more effective months or more, the FDA said. Pfizer’s clinical protocol says the company will continue to follow participants for two years after the second dose. Results show the treatment is safe to use in this age group, causing side effects similar to those seen in young adult populations for whom it had already been cleared, according to the FDA in a press release.

Those vaccinated also produced a strong immune response — the level of antibodies recorded in this age group was even stronger than what was how to make levitra more effective seen in 16- to 25-year-olds. The vaccinated group also had no erectile dysfunction treatment cases when tested seven days after their second dose. Sixteen participants out of 978 who did not get the shot but were followed as part of the study as a control group tested positive for the levitra.

In short, the treatment was 100% effective in preventing erectile dysfunction treatment, how to make levitra more effective according to the FDA. Why So Few Kids?. One data point that may give parents pause is the trial’s number of participants.

The relatively how to make levitra more effective low number — especially when compared with the tens of thousands enrolled in adult trials — is a reflection of what the researchers were trying to accomplish, said Dr. Kawsar Talaat, an assistant professor of international health at Johns Hopkins University School of Public Health. Gauging whether the shot was safe for children and if it generated a strong immune response did not require a large study group, she said.

Statisticians can calculate how many people a trial needs to generate meaningful results without how to make levitra more effective unnecessarily exposing people to dangerous pathogens like the erectile dysfunction. In addition, the findings pertaining to the younger age group built on what has already been learned in earlier studies. €œIt’s just not practical to do 30,000-person trials over and over with the same treatment,” Talaat said.

Large trials are expensive, she added how to make levitra more effective. Including minors also poses extra challenges, said Stager, such as getting parental consent. Jerica Pitts, a Pfizer spokesperson, said in an email the company is using a “careful, stepwise approach” to including minors in clinical trials.

Stager said physiological similarities among 12- how to make levitra more effective to 15-year-olds in response to treatments have previously been documented. Studies related to a treatment for the human papillomalevitra have shown kids at this age generated similar, strong immune responses, too. Administering the treatment to preteens and young adolescents in large numbers may reveal additional effects that weren’t detected in the clinical trials, said A.

Oveta Fuller, how to make levitra more effective associate professor of microbiology and immunology at the University of Michigan Medical School. That said, when weighing the threat of the levitra versus the treatment’s proven safety, she said, the choice is clear. €œThe thing is the danger is really not so much the treatments as it is what it protects against,” Fuller said, “and that’s erectile dysfunction treatment disease.” Carmen Heredia Rodriguez.

CarmenH@kff.org, @ByCHRodriguez Related Topics Contact Us Submit a Story TipUna nueva encuesta revela que los hispanos tienen how to make levitra more effective el doble de interés en vacunarse “lo antes posible” que los blancos no hispanos o personas de raza negra no hispanas. Los datos muestran que los problemas de acceso siguen siendo difíciles para la población. Un tercio de los hispanos no vacunados dicen que quieren las dosis, en comparación con el 17% de los negros y el 16% de los blancos, según la encuesta publicada por KFF (Kaiser Family Foundation).

€œLos resultados reflejan una oportunidad para que los departamentos de salud pública y los gobiernos locales lleguen a los hispanos con información y equipos de vacunación”, señaló Liz Hamel, vicepresidenta y directora de opinión pública e investigación de encuestas en KFF, quien lidera las encuestas mensuales how to make levitra more effective de la organización sobre la vacuna contra erectile dysfunction treatment. €œDefinitivamente, hay una gran parte de la población hispana que está deseando vacunarse, pero no han podido encontrar el tiempo, o tienen algunas preocupaciones o preguntas, o no han podido acceder a la vacuna”, dijo Hamel. Según los Centros para el Control y la Prevención de Enfermedades (CDC), sólo alrededor del 13% de las personas en los Estados Unidos que han recibido al menos una dosis de la vacuna son hispanas, aunque constituyen alrededor del 17% de la población total.

(Sólo la mitad de los datos de los CDC incluyen la raza o how to make levitra more effective el origen étnico de las personas vacunadas). Entre los hispanos no vacunados, el 64% estaba preocupado por la posibilidad de faltar al trabajo debido a los efectos secundarios de la vacuna, y el 52% estaba preocupado por tener que pagar las vacunas, aunque éstas se ofrecen sin costo alguno. Estas cifras son aún más altas entre los hispanos indocumentados.

€œEs difícil que alguien que vive al día se tome medio día libre para venir a how to make levitra more effective una clínica y tratar de vacunarse”, dijo el doctor José Pérez, jefe médico del South Central Family Health Center, una organización de salud sin fines de lucro con clínicas en todo el sur de Los Ángeles. €œSi no trabajan ese día, no se ganan la vida y no comen”. Aquéllos que se enfrentan a problemas de inmigración fueron más propensos a preocuparse por tener que mostrar una identificación emitida por el gobierno o un número de seguro social, según la encuesta de KFF.

Las políticas antiinmigrantes de la administración Trump asustaron a las personas que buscaban cualquier servicio de salud pública, how to make levitra more effective por temor a que pudiera poner en peligro su estatus migratorio, dijo Pérez. €œPara los estadounidenses que están acostumbrados a tener orden en su vida, y no tienen que tener miedo de esto o aquello, esto puede parecer un poco extraño. Pero para la comunidad inmigrante del sur de Los Ángeles, estos son factores con los que lidian a diario”, agregó.

A pesar del mensaje esperanzador de la encuesta, la organización how to make levitra more effective de Pérez sólo ha administrado una fracción de las dosis que tiene a mano, aunque ha ampliado los lugares de vacunación, y ahora ofrece una vacuna a cualquiera que entre en una de sus clínicas, dijo Pérez. €œTodo lo que podemos hacer es seguir empujando, educando, y poniendo nuestro nombre ahí fuera. Con suerte, nos pondremos al día”, apuntó.

La administración Biden anunció recientemente créditos fiscales para las pequeñas empresas que den a sus trabajadores tiempo libre remunerado para recibir la vacuna y recuperarse en caso de efectos how to make levitra more effective secundarios. Los proveedores no están autorizados a cobrar a la gente por la vacuna contra erectile dysfunction treatment, y deben repartir las vacunas independientemente del estatus migratorio o del seguro médico. En California, en donde los hispanos representan cerca del 40% de la población, el 48% de las muertes por erectile dysfunction treatment y el 63% de los casos, alrededor del 32% se ha vacunado.

Los casos y muertes están particularmente concentrados en los how to make levitra more effective vecindarios de bajos ingresos, mayormente hispanos. Las clínicas de salud comunitarias y las organizaciones de todo el estado están llevando la causa de las vacunas a las aceras, los supermercados y cualquier otro lugar donde se reúna la gente, buscando asegurar que sepan cómo obtener una cita para vacunarse. Carmelo Morales era uno de los escépticos hasta que vio como colegas y familiares morían por erectile dysfunction treatment en la empacadadora de carne en donde trabaja.

Se decidió a vacunarse en abril.(Anna Almendrala / KHN) En el código postal que rodea la sede principal de South Central Family Health Center, sólo el 16% de los residentes elegibles tenían al menos una dosis hasta el 7 de mayo, según el rastreador de vacunas del Departamento how to make levitra more effective de Salud Pública de California. A cinco meses que comenzara la campaña de vacunación de la nación, mientras los CDC relajan las recomendaciones del uso de máscara, la clínica todavía está empujando la importancia de las máscaras debido a la baja cantidad de personas que se han vacunado, dijo Pérez. La “indecisión en la vacunación” se ha convertido en una excusa general para explicar las bajas tasas de vacunación entre las poblaciones minoritarias, pero el problema es complejo, dijo Nancy Mejía, directora del programa de Acceso a la Salud de los Latinos en Santa Ana, California, una organización sin fines de lucro que tiene un contrato con el condado de Orange para llevar la vacuna contra erectile dysfunction treatment a los latinos.

Las promotoras de su grupo se encuentran con personas que se enfrentan a una gran variedad de obstáculos para vacunarse, how to make levitra more effective dijo. €œOímos todas estas preguntas. €˜Bueno, no tengo seguro médico’, o ‘¿Tengo que pagar?.

€™ o ‘No tengo correo how to make levitra more effective electrónico, ¿cómo me registro?. '”, contó Mejía. €œCuando la gente habla de indecisión, realmente tenemos que preguntar de qué estamos hablando, y no seguir echando la culpa a las personas que realmente tienen buenas preguntas”.

Ahora que la demanda de citas para la vacunación ha caído, Mejía y su grupo se están centrando más en eventos de vacunación móviles en edificios de condominios y estacionamientos a donde peatones y residentes pueden simplemente caminar. Los eventos son por las tardes, después del trabajo, o los fines de semana, para que la decisión de vacunarse sea lo más fácil posible. €œVemos que otros lugares han estado abiertos todo el día y sólo han entrado cinco personas”, dijo.

€œAsí que, para nosotros, estar abiertos sólo unas horas por la tarde, y conseguir más de 100 personas es un gran éxito”. Carmelo Morales, de 35 años y residente de Los Ángeles, era uno de los escépticos. Tras hablar con amigos y ver publicaciones en Instagram, temía que las vacunas fueran un complot para enfermar a la gente.

No veía la urgencia de vacunarse. Pero Morales, que trabaja en una planta empacadora de carne, se ha visto profundamente afectado por los casos y las muertes entre sus colegas y sus familias en el último año. Un día a finales de abril, mientras volvía a casa del trabajo, vio que los trabajadores de salud de una iglesia cercana a su casa estaban limpiando después de un evento de vacunación contra erectile dysfunction treatment.

What does this mean for canada levitra online my child?. Extending the emergency use of the Pfizer-BioNTech treatment to preteens and young adolescents adds nearly 17 million more Americans to the pool of those eligible to be immunized against erectile dysfunction treatment, helping to build a vaccinated population closer to herd immunity. Moderna and Johnson &. Johnson are also testing the efficacy canada levitra online of their treatments in teens and children.

Although children appear to catch erectile dysfunction treatment less often and develop milder symptoms than adults, they can develop a rare, severe inflammatory response or “long-haul erectile dysfunction treatment” symptoms. It also remains to be seen what, if any, long-term effects these younger patients may experience from erectile dysfunction treatment. The share of erectile dysfunction treatment cases in children and teens is increasing canada levitra online — nearly a quarter of the new weekly erectile dysfunction treatment cases were found in this age group, as reported May 6 by the American Academy of Pediatrics and the Children’s Hospital Association. And, though kids have been less likely to develop severe illness, they still can pose a risk to vulnerable people around them because they may not even know they are carrying the levitra, as documented by the Centers for Disease Control and Prevention.

Dr. Margaret Stager, a pediatrician and the division director of adolescent medicine at MetroHealth Medical Center in Cleveland, said she has had to explain to her young patients that getting immunized would help their community curb canada levitra online the spread, cut the risk of variants and help society reopen. €œI talk about them doing their part,” Stager said. €œThat this is all part of them contributing to the greater good.” The Fine Print The CDC this week recommended use of the Pfizer treatment for children ages 12 to 15 after the Food and Drug Administration extended its emergency use authorization to include these preteens and young adolescents.

That means canada levitra online this age group now can receive the same shots in the same time frame — 21 days apart — as adults do. In a reversal of its previous guidance, teens and adults do not need to wait 14 days before or after getting the erectile dysfunction treatment shot to receive a treatment for another condition. This could be a boon for health care providers who have child patients lagging on other, routine treatments, which has been a persistent problem during the levitra. €œIt’s a tremendous opportunity to play catch-up,” said Stager canada levitra online.

CDC officials noted in the May 12 Advisory Committee on Immunization Practices’ recommendation that they do not have data specifically looking at potential side effects in patients immunized against erectile dysfunction treatment and other illnesses at the same time. However, the agency made the decision given the strong safety data of the Pfizer-BioNTech shot and previous experience with other immunizations. This question will become more important as erectile dysfunction treatments are studied in younger canada levitra online children. Trials are planned to test the treatment in children as young as 6 months old.

As in adults, the question of how long the immunity lasts in children remains unknown, said Dr. Rebecca Wurtz, an associate professor canada levitra online of infectious diseases at the University of Minnesota. However, she said, it’s likely that any waning immunity detected in adults will also be seen among the young. €œWhatever we learn in adults,” Wurtz said, “kids will be not far behind.” Whether this approval will prompt schools to require vaccination against erectile dysfunction treatment for K-12 students returning to the classroom this fall is a pending question, said Stager.

It is unclear canada levitra online whether federal law allows state authorities to mandate a treatment that has not yet been fully approved. That said, the government’s approval will also likely play into parents’ decisions about sending their children to summer camp. What Did the Trial Find?. Pfizer tested the treatment in canada levitra online 2,260 preteens and young adolescents living in the United States.

Researchers followed participants for two months or more, the FDA said. Pfizer’s clinical protocol says the company will continue to follow participants for two years after the second dose. Results show the treatment is safe to use in canada levitra online this age group, causing side effects similar to those seen in young adult populations for whom it had already been cleared, according to the FDA in a press release. Those vaccinated also produced a strong immune response — the level of antibodies recorded in this age group was even stronger than what was seen in 16- to 25-year-olds.

The vaccinated group also had no erectile dysfunction treatment cases when tested seven days after their second dose. Sixteen participants out of 978 who did not get canada levitra online the shot but were followed as part of the study as a control group tested positive for the levitra. In short, the treatment was 100% effective in preventing erectile dysfunction treatment, according to the FDA. Why So Few Kids?.

One data point that may give parents canada levitra online pause is the trial’s number of participants. The relatively low number — especially when compared with the tens of thousands enrolled in adult trials — is a reflection of what the researchers were trying to accomplish, said Dr. Kawsar Talaat, an assistant professor of international health at Johns Hopkins University School of Public Health. Gauging whether the shot was safe for canada levitra online children and if it generated a strong immune response did not require a large study group, she said.

Statisticians can calculate how many people a trial needs to generate meaningful results without unnecessarily exposing people to dangerous pathogens like the erectile dysfunction. In addition, the findings pertaining to the younger age group built on what has already been learned in earlier studies. €œIt’s just not practical to do 30,000-person trials over and over with the same treatment,” canada levitra online Talaat said. Large trials are expensive, she added.

Including minors also poses extra challenges, said Stager, such as getting parental consent. Jerica Pitts, a Pfizer spokesperson, said in an canada levitra online email the company is using a “careful, stepwise approach” to including minors in clinical trials. Stager said physiological similarities among 12- to 15-year-olds in response to treatments have previously been documented. Studies related to a treatment for the human papillomalevitra have shown kids at this age generated similar, strong immune responses, too.

Administering the treatment to preteens and young adolescents in large numbers may reveal additional effects that canada levitra online weren’t detected in the clinical trials, said A. Oveta Fuller, associate professor of microbiology and immunology at the University of Michigan Medical School. That said, when weighing the threat of the levitra versus the treatment’s proven safety, she said, the choice is clear. €œThe thing is the danger is really not so much the treatments as canada levitra online it is what it protects against,” Fuller said, “and that’s erectile dysfunction treatment disease.” Carmen Heredia Rodriguez.

CarmenH@kff.org, @ByCHRodriguez Related Topics Contact Us Submit a Story TipUna nueva encuesta revela que los hispanos tienen el doble de interés en vacunarse “lo antes posible” que los blancos no hispanos o personas de raza negra no hispanas. Los datos muestran que los problemas de acceso siguen siendo difíciles para la población. Un tercio de los hispanos no vacunados dicen que quieren las dosis, en comparación con el 17% de los negros y el 16% de los canada levitra online blancos, según la encuesta publicada por KFF (Kaiser Family Foundation). €œLos resultados reflejan una oportunidad para que los departamentos de salud pública y los gobiernos locales lleguen a los hispanos con información y equipos de vacunación”, señaló Liz Hamel, vicepresidenta y directora de opinión pública e investigación de encuestas en KFF, quien lidera las encuestas mensuales de la organización sobre la vacuna contra erectile dysfunction treatment.

€œDefinitivamente, hay una gran parte de la población hispana que está deseando vacunarse, pero no han podido encontrar el tiempo, o tienen algunas preocupaciones o preguntas, o no han podido acceder a la vacuna”, dijo Hamel. Según los Centros para el Control y la Prevención de Enfermedades (CDC), sólo alrededor del 13% de las personas en los Estados Unidos que han recibido al menos una dosis de la vacuna son hispanas, aunque constituyen alrededor del 17% canada levitra online de la población total. (Sólo la mitad de los datos de los CDC incluyen la raza o el origen étnico de las personas vacunadas). Entre los hispanos no vacunados, el 64% estaba preocupado por la posibilidad de faltar al trabajo debido a los efectos secundarios de la vacuna, y el 52% estaba preocupado por tener que pagar las vacunas, aunque éstas se ofrecen sin costo alguno.

Estas cifras son aún canada levitra online más altas entre los hispanos indocumentados. €œEs difícil que alguien que vive al día se tome medio día libre para venir a una clínica y tratar de vacunarse”, dijo el doctor José Pérez, jefe médico del South Central Family Health Center, una organización de salud sin fines de lucro con clínicas en todo el sur de Los Ángeles. €œSi no trabajan ese día, no se ganan la vida y no comen”. Aquéllos que se enfrentan a problemas de canada levitra online inmigración fueron más propensos a preocuparse por tener que mostrar una identificación emitida por el gobierno o un número de seguro social, según la encuesta de KFF.

Las políticas antiinmigrantes de la administración Trump asustaron a las personas que buscaban cualquier servicio de salud pública, por temor a que pudiera poner en peligro su estatus migratorio, dijo Pérez. €œPara los estadounidenses que están acostumbrados a tener orden en su vida, y no tienen que tener miedo de esto o aquello, esto puede parecer un poco extraño. Pero para la comunidad inmigrante del sur de Los Ángeles, estos son factores canada levitra online con los que lidian a diario”, agregó. A pesar del mensaje esperanzador de la encuesta, la organización de Pérez sólo ha administrado una fracción de las dosis que tiene a mano, aunque ha ampliado los lugares de vacunación, y ahora ofrece una vacuna a cualquiera que entre en una de sus clínicas, dijo Pérez.

€œTodo lo que podemos hacer es seguir empujando, educando, y poniendo nuestro nombre ahí fuera. Con suerte, canada levitra online nos pondremos al día”, apuntó. La administración Biden anunció recientemente créditos fiscales para las pequeñas empresas que den a sus trabajadores tiempo libre remunerado para recibir la vacuna y recuperarse en caso de efectos secundarios. Los proveedores no están autorizados a cobrar a la gente por la vacuna contra erectile dysfunction treatment, y deben repartir las vacunas independientemente del estatus migratorio o del seguro médico.

En California, en donde los hispanos representan cerca del canada levitra online 40% de la población, el 48% de las muertes por erectile dysfunction treatment y el 63% de los casos, alrededor del 32% se ha vacunado. Los casos y muertes están particularmente concentrados en los vecindarios de bajos ingresos, mayormente hispanos. Las clínicas de salud comunitarias y las organizaciones de todo el estado están llevando la causa de las vacunas a las aceras, los supermercados y cualquier otro lugar donde se reúna la gente, buscando asegurar que sepan cómo obtener una cita para vacunarse. Carmelo Morales era uno de los escépticos hasta que vio como colegas y familiares morían por erectile dysfunction treatment en canada levitra online la empacadadora de carne en donde trabaja.

Se decidió a vacunarse en abril.(Anna Almendrala / KHN) En el código postal que rodea la sede principal de South Central Family Health Center, sólo el 16% de los residentes elegibles tenían al menos una dosis hasta el 7 de mayo, según el rastreador de vacunas del Departamento de Salud Pública de California. A cinco meses que comenzara la campaña de vacunación de la nación, mientras los CDC relajan las recomendaciones del uso de máscara, la clínica todavía está empujando la importancia de las máscaras debido a la baja cantidad de personas que se han vacunado, dijo Pérez. La “indecisión en la vacunación” se ha convertido en una excusa general para explicar las bajas tasas de vacunación entre las poblaciones minoritarias, pero el problema es complejo, dijo Nancy Mejía, directora del programa de Acceso canada levitra online a la Salud de los Latinos en Santa Ana, California, una organización sin fines de lucro que tiene un contrato con el condado de Orange para llevar la vacuna contra erectile dysfunction treatment a los latinos. Las promotoras de su grupo se encuentran con personas que se enfrentan a una gran variedad de obstáculos para vacunarse, dijo.

€œOímos todas estas preguntas. €˜Bueno, no tengo seguro médico’, o canada levitra online ‘¿Tengo que pagar?. €™ o ‘No tengo correo electrónico, ¿cómo me registro?. '”, contó Mejía.

€œCuando la gente habla de indecisión, realmente tenemos que preguntar de qué estamos hablando, y no seguir echando la culpa canada levitra online a las personas que realmente tienen buenas preguntas”. Ahora que la demanda de citas para la vacunación ha caído, Mejía y su grupo se están centrando más en eventos de vacunación móviles en edificios de condominios y estacionamientos a donde peatones y residentes pueden simplemente caminar. Los eventos son por las tardes, después del trabajo, o los fines de semana, para que la decisión de vacunarse sea lo más fácil posible. €œVemos que otros lugares han estado abiertos canada levitra online todo el día y sólo han entrado cinco personas”, dijo.

€œAsí que, para nosotros, estar abiertos sólo unas horas por la tarde, y conseguir más de 100 personas es un gran éxito”. Carmelo Morales, de 35 años y residente de Los Ángeles, era uno de los escépticos. Tras hablar con amigos y ver publicaciones en Instagram, temía que las vacunas fueran un complot canada levitra online para enfermar a la gente. No veía la urgencia de vacunarse.

Pero Morales, que trabaja en una planta empacadora de carne, se ha visto profundamente afectado por los casos y las muertes entre sus colegas y sus familias en el último año. Un día a finales de abril, mientras volvía a casa del trabajo, vio que los trabajadores de salud de una iglesia cercana a canada levitra online su casa estaban limpiando después de un evento de vacunación contra erectile dysfunction treatment. Preguntó si había dosis sobrantes y, como su casa estaba cerca, las enfermeras esperaron a que corriera a su casa a buscar su identificación para que pudiera ponerse la primera dosis. €œSólo pensé y me dije, oye, es mejor sólo para estar del lado más seguro”.

Levitra trial card

Air conditioning and other cooling systems are widely recognized as integral to protecting people from the sometimes deadly impacts of extreme heat, levitra trial card which are like this intensifying in step with climate change. Yet according to a study, published yesterday in Nature Sustainability, there remains a “global blind spot” when it comes to handling the already exorbitant demand for cooling and indoor air conditioning, which alone is projected to triple by 2050. That’s a stark levitra trial card reality, the report warns, given that many cooling systems are carbon-intensive—and contribute to global warming themselves. €œCooling is essential to human well-being and health, from the food we eat to the storage of medicine to how comfortable and productive we are at home, school or the office,” said report co-author Radhika Khosla, a principal investigator at the Oxford Martin Programme on the Future of Cooling.

So if societies do not soon begin implementing sustainable cooling solutions, Khosla added in a statement, they risk “locking the world into a deadly feedback loop, where demand for cooling energy drives further greenhouse gas emissions and results in even more global warming.” The researchers examined thousands of peer-reviewed papers related to the United Nations’ Sustainable Development Goals and concluded that greener cooling systems could help achieve all 17 goals—which include curbing global hunger, reducing gender inequality and improving human health writ large. That’s possible, the report said, because extreme heat dramatically affects everything from food production to water quality to levitra trial card students’ ability to learn and focus during school. Despite evidence that demonstrates the connection between efficient cooling systems and improved social and environmental outcomes, however, the authors argue that the “unprecedented rise in demand and the potential benefits of sustainable cooling” remain largely neglected in contemporary sustainability debates. That has major levitra trial card implications, they emphasized, for sustainable development around the world.

To close that gap, the study said technological developments, innovative business models, intentional infrastructure and regulation could be used to make cooling more accessible—and climate friendly. Cities and towns, for instance, could embed “passive and energy-efficient” cooling mechanisms in urban infrastructure to lessen the impact of extreme heat both indoors and outdoors. That could entail projects intended to reduce the prominence of “urban heat islands” by planting additional trees, developing new parks and building green roofs—all of levitra trial card which naturally cool urban spaces. Those strategies would be especially useful, the report said, given that “projections of the world’s population living in towns and cities are set to reach 66% by 2050,” making urban areas the “epicentre of cooling demand.” The authors also suggest that air-conditioning companies adopt a “cooling as a service” business model, intended to making sustainable cooling more affordable—especially in hot, low-income regions.

Rather than charging for the system itself, the companies would profit by retaining ownership of it and charging customers to operate the system and maintain a comfortable thermal environment. This would drive down, or even eliminate, what can be prohibitive upfront costs for cash-strapped levitra trial card households. In the context of a world “positioned at the brink of unprecedented cooling demand,” the report says, these interventions are among the many that offer “a way forward while being acutely aware of the extraordinary opportunity the current moment provides to use cooling as a lens to look to the sustainability of our future.” Reprinted from Climatewire with permission from E&E News. E&E provides daily coverage of essential energy levitra trial card and environmental news at www.eenews.net.Tempers are running hot in science (as they are in the U.S.

At large) as the field embarks on a long-overdue conversation about its treatment of women and people of color. In June, for example, thousands of researchers and academics across the globe—as well as the preeminent journals Science and Nature—stopped work for a day to protest racism in their ranks. The American Physical Society endorsed the effort to “shut down STEM,” declaring its commitment levitra trial card to “eradicating systemic racism and discrimination” in science. Physics exemplifies the problem.

African-Americans make up about 14 percent of the college-age population in the U.S., commensurate with their numbers in the overall population, but in physics they receive 3 to 4 percent of undergraduate degrees and less than 3 percent of Ph.D.s, and as of 2012 they composed only 2 percent of faculty. No doubt there are many reasons for this underrepresentation, but one troubling factor is the refusal of some scientists to acknowledge that a problem levitra trial card could even exist. Science, they argue, is inherently rational and self-correcting. Would that levitra trial card were true.

The history of science is rife with well-documented cases of misogyny, prejudice and bias. For centuries biologists promoted false theories of female inferiority, and scientific institutions typically barred women's participation. Historian of science and MacArthur fellow Margaret levitra trial card Rossiter has documented how, in the mid-19th century, female scientists created their own scientific societies to compensate for their male colleagues' refusal to acknowledge their work. Sharon Bertsch McGrayne filled an entire volume with the stories of women who should have been awarded the Nobel Prize for work that they did in collaboration with male colleagues—or, worse, that they had stolen by them.

(Rosalind Franklin is a well-documented example of the latter. Her photographs levitra trial card of the crystal structure of DNA were shared without her permission by one of the men who then won the Nobel Prize for elucidating the double-helix structure.) Racial bias has been at least as pernicious as gender bias. It was scientists, after all, who codified the concept of race as a biological category that was not simply descriptive but also hierarchical. Good scientists are open to competing levitra trial card ideas.

They attend to challenging data, and they listen to opposing views. But scientists are also humans, and cognitive science shows that humans are prone to bias, misperception, motivated reasoning and other intellectual pitfalls. Because reasoning is slow and difficult, we rely levitra trial card on heuristics—intellectual shortcuts that often work but sometimes fail spectacularly. (Believing that men are, in general, better than women in math is one tiring example.) It is not credible to claim that scientists are somehow immune to the biases that afflict everyone else.

Fortunately, the objectivity of scientific knowledge does not depend on the levitra trial card objectivity of individual scientists. Rather it depends on strategies for identifying, acknowledging and correcting bias and error. As I point out in my 2019 book, Why Trust Science, scientific knowledge begins as claims advanced by individual scientists, teams or laboratories that are then closely scrutinized by others, who may bring forward additional proof to sustain them—or to modify or reject them. What emerges as a scientific fact or levitra trial card established theory is rarely if ever the same as the starting claim.

It has been adjusted in light of evidence and argumentation. Science is a collective effort, and it works best when scientific communities are diverse. The reason is levitra trial card simple. Heterogeneous communities are more likely than homogeneous ones to be able to identify blind spots and correct them.

Science does levitra trial card not correct itself. Scientists correct one another through critical interrogation. And that means being willing to interrogate not just claims about the external world but claims about our own practices and processes as well. Science has an admirable record of producing levitra trial card reliable knowledge about the natural and social world, but not when it comes to acknowledging its own weaknesses.

And we cannot correct those weaknesses if we insist the system will magically correct itself. It is not ideological to acknowledge and confront bias in science. It is ideological to levitra trial card insist science cannot be biased despite empirical validation to the contrary. Given that our failings of inclusion have been known for a long time, it is high time we finally fix them.Young, healthy people will be intentionally exposed to the levitra responsible for erectile dysfunction treatment in a first-of-its kind ‘human challenge trial’, the UK government and a company that runs such studies announced on 20 October.

The experiment, set to begin in January in a levitra trial card London hospital if it receives final regulatory and ethical approval, aims to accelerate the development of treatments that could end the levitra. Human challenge trials have a history of providing insight into diseases such as malaria and influenza. The UK trial will try to identify a suitable dose of the levitra erectile dysfunction that could be used in future treatment trials. But the prospect of deliberately infecting people—even those at low risk of severe disease—with erectile dysfunction, a deadly levitra trial card pathogen that has few proven treatments, is uncharted medical and bioethical territory.

Proponents of erectile dysfunction treatment challenge trials have argued that they can be run safely and ethically, and that their potential to quickly identify effective treatments outweighs the low risks to participants. But others have raised questions about the safety and value of these studies, pointing out that large-scale efficacy trials involving tens of thousands of people are expected to deliver results on several erectile dysfunction treatments soon. €œDeliberately infecting volunteers with a known human pathogen levitra trial card is never undertaken lightly. However, such studies are enormously informative about a disease,” said Peter Openshaw, an immunologist at Imperial College London and investigator on the study, in a press statement.

€œIt is really vital that we move levitra trial card as fast as possible towards getting effective treatments and other treatments for erectile dysfunction treatment, and challenge studies have the potential to accelerate and de-risk the development of novel drugs and treatments.” Dose testing The planned erectile dysfunction treatment challenge study will be led by a Dublin-based commercial clinical-research organization called Open Orphan and its subsidiary hVIVO, which runs challenge trials on respiratory pathogens. It will take place in the high-level isolation unit of the Royal Free Hospital in north London, says Open Orphan executive chair Cathal Friel. The UK government’s erectile dysfunction treatment Taskforce has agreed to pay the company up to £10 million (US$13 million) to conduct the trial, with the possibility of contracting Open Orphan to run several more to test various treatments. The UK Medicines and Healthcare Regulatory Agency levitra trial card (MHRA), which regulates clinical trials in the United Kingdom, and an ethical review committee, still need to approve the initial trial and its design, and that of future studies.

The initial trial will involve an estimated 30–50 participants, says Andrew Catchpole, a virologist and the chief scientific officer at Open Orphan who is leading the work. It is open only to levitra trial card healthy adults aged 18–30. The precise design of the study has not been finalized. But it is likely that a small number of participants will receive a very low dose of a erectile dysfunction ‘challenge strain’ derived from a currently circulating levitra and grown under stringent conditions.

If none or few of the participants become infected, the researchers will seek permission from an independent safety monitoring board to levitra trial card expose participants to higher doses. This process will be repeated until researchers identify a dose that infects most of those exposed, says Catchpole. Once an appropriate dose is identified, Open Orphan could be asked to run a series of challenge trials testing several treatments. Catchpole says that the design of these trials, including which treatments will be included, levitra trial card has not been determined.

He envisions that some trial participants will receive a placebo injection instead of a treatment, but he also says that head-to-head trials comparing two or more treatments could be run. Other treatment studies that the company runs typically enrol 40–50 volunteers for each trial arm, he says levitra trial card. Catchpole says that his team will take every precaution against participants in the initial trial developing severe disease. Volunteers will be treated with an antiviral drug, such as remdesivir, once a nasal swab gives a positive result for erectile dysfunction genetic material.

In addition to age and health, participants will be screened for risk factors that have been associated with severe levitra trial card erectile dysfunction treatment. Selecting participants at the lowest risk is the most important safety step in running a challenge trial, says Matt Memoli, an infectious-disease physician and virologist at the US National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, Maryland. €œOnce you’ve given that levitra to the person, anything’s possible,” he says. €œYou can’t control it, you can only react levitra trial card to it.” If Open Orphan moves on to treatment trials, it will aim to recruit around 500 participants altogether, but Friel says the company will need to screen many times more people to identify suitable volunteers.

An ethical review board will determine how to compensate participants. Open Orphan levitra trial card typically pays volunteers around £4,000 for their time, says Catchpole. Ethical issues There is a concern that people will participate for the money without appreciating the risks, says Nir Eyal, a bioethicist at Rutgers University in New Brunswick, New Jersey, who has argued that erectile dysfunction treatment challenge trials can be run safely and ethically. But a well-designed online course, for instance, could ensure that participants understand the risks, he says.

Ensuring that participants understand the limitations of challenge trials will also be important, says Seema Shah, a bioethicist at Lurie Children’s Hospital and Northwestern University in Chicago, levitra trial card Illinois. With phase III trials of numerous erectile dysfunction treatments in the works, she thinks it unlikely that challenge trials will speed the development of the first treatments. Instead, their payoff could lie in helping to test later-generation treatments or laying the groundwork for fresh insights into the disease. In this context, says Shah, “It becomes levitra trial card a little bit harder to justify them, and we need to take a close look at risks.” Meagan Deming, a treatment scientist and virologist at the University of Maryland School of Medicine in Baltimore, sees challenge trials as more appropriate for studying basic aspects of erectile dysfunction —such as the potential for re or how previous exposure to cold-causing erectile dysfunctiones influences susceptibility to erectile dysfunction treatment—than for vetting treatments.

Because such trials are likely to involve only young, healthy people, they might not reveal much about how treatments could protect those most at risk of severe disease, such as older people and those with conditions such as diabetes, Deming says. €œThere’s a reason we don’t have levitra trial card a lot of treatments approved by challenge models, because they don’t apply to everyone and you want a treatment to protect almost everyone,” she says. Phase III trials might not offer clear evidence of whether treatments work in older people, because of their low participation in those trials, says Peter Smith, an epidemiologist at the London School of Hygiene and Tropical Medicine who has been involved in challenge trials. Researchers will probably need to determine treatments’ likely effectiveness in older people, on the basis of how their immune systems respond to erectile dysfunction treatments before exposure to the levitra.

And compared with field trials, challenge studies are better at identifying the types of immune response that predict whether a levitra trial card treatment is likely to work or not, adds Memoli. Other trials The United Kingdom isn’t the only country investigating erectile dysfunction treatment challenge trials. Belgium’s government has committed €20 million (US$23.6 million) for facilities to host challenge trials, potentially involving erectile dysfunction treatment. NIAID is funding the development of two erectile dysfunction challenge strains by a lab at Colorado State University in levitra trial card Fort Collins, and a team led by Memoli is also laying the groundwork for such trials.

In a statement, NIAID said it was awaiting data from phase III studies before making decisions on erectile dysfunction treatment challenge trials. Proponents of the trials argue that levitra trial card the consequences of delaying them should be taken into account, alongside the risks of going forward. For instance, Eyal and economists Pedro Rosa Dias and Ara Darzi at Imperial College London have calculated that speeding up the development of erectile dysfunction treatments by one month would avert the loss of 720,000 years of life and prevent 40 million years in poverty, mostly in lower-income countries. But Deming thinks that challenge trials should wait until their value is clearer and the risks can be better mitigated, for instance by deploying more potent therapies.

€œWe don’t levitra trial card yet know enough about this disease to say for this person. You will not die,” she says. €œWe’ve learned levitra trial card so much in the past nine months. In a year, we will be able to do this safely.” This article is reproduced with permission and was first published on October 20 2020.For the first time ever, a NASA probe has performed a sample-snagging operation on an asteroid in deep space.

The agency’s OSIRIS-REx spacecraft spiraled down to the surface of the near-Earth asteroid Bennu this afternoon (Oct. 20) to grab material that mission team members hope harbors clues about the solar system’s early days and the rise of life levitra trial card on Earth. €œWe did it!. € OSIRIS-REx principal investigator Dante Lauretta, of the University of Arizona, said during a webcast that provided updates about today’s maneuver.

€œWe tagged the surface of the asteroid, and it’s up to Bennu now to see how the event went.” The goal was to collect at least levitra trial card 60 grams (2.1 ounces) of dirt and gravel from Bennu’s rubbly surface. It could take up to 10 days to determine if OSIRIS-REx achieved this aim, mission team members have said. And it’s not a disaster if the asteroid haul levitra trial card turns out to be a little light. The probe can go back down for two more tries if need be.

“This amazing first for NASA demonstrates how an incredible team from across the country came together and persevered through incredible challenges to expand the boundaries of knowledge,” NASA Administrator Jim Bridenstine said in a statement after the touchdown. €œOur industry, academic, and international partners have made it possible to hold a piece of the most ancient solar system in our levitra trial card hands.” Lauretta and his fellow OSIRIS-REx scientists and engineers watched over today’s asteroid sample-snatching attempt from a mission operations center at Lockheed Martin Space in Littleton, Colorado. (Lockheed Martin built the spacecraft for NASA.) And while the mood was certainly jubilant, the impact of the ongoing erectile dysfunction treatment levitra was clear. For example, everyone wore facemasks and maintained appropriate social distancing for much of the event.

While there were some hugs after news of OSIRIS-REx’s asteroid touchdown, they were few in NASA’s live webcast, with hand levitra trial card sanitizer clearly on hand after such celebrations. “This is one of those moments where we’re all aware of erectile dysfunction treatment,” NASA astronomer Michelle Thaller of the Goddard Space Flight Center said in the webcast just after touchdown. €œBecause I want levitra trial card the hugs and the high fives and everything, but we’re all going to keep each other safe.” The $800 million OSIRIS-REx mission launched in September 2016 and arrived at the 1,640-foot-wide (500 meters) Bennu in December 2018. The probe has been taking the asteroid’s measure ever since, mapping its surface in incredible detail to prepare for today’s maneuver.

That work has revealed a world far more rugged than the mission team had expected. House-sized boulders stud Bennu’s surface, limiting the available options for levitra trial card a safe sample grab. The team eventually homed in on a small crater called Nightingale as its top choice, because the site sports relatively fresh and fine-grained material that hasn’t been exposed to the harsh deep-space environment for long. But Nightingale is surrounded by hazards, including a big outcrop the mission team nicknamed “Mount Doom.” There are obstacles within the crater as well, so the spacecraft targeted a relatively flat, boulder-free area just 26 feet (8 m) wide—quite an ambitious goal, considering that OSIRIS-REx is the size of a 15-passenger van and the original mission plan envisioned a touchdown zone 165 feet (50 m) wide.

€œSo, for some levitra trial card perspective. The next time you park your car in front of your house or in front of a coffee shop and walk inside, think about the challenge of navigating OSIRIS-REx into one of these spots from 200 million miles away,” Mike Moreau, OSIRIS-REx deputy project manager at NASA’s Goddard Space Flight Center in Greenbelt, Maryland, said during a news conference last month. It currently takes more than 18 minutes for commands to travel from levitra trial card Earth to OSIRIS-REx, so Moreau and his colleagues cannot control the probe in real time. The craft therefore performed today’s operation autonomously.

Shortly before 2 p.m. EDT (1600 GMT) today, OSIRIS-REx fired its thrusters to get out of orbit around Bennu and head down toward the surface levitra trial card. At 6:12 p.m. EDT (2212 GMT), the probe “kissed” the asteroid for about 10 seconds with its sample-collecting mechanism, which is affixed to the end of OSIRIS-REx’s 11-foot-long (3.4 m) robotic levitra trial card arm.

During the brief touchdown, the spacecraft blasted Bennu’s surface with nitrogen gas. This stirred up dirt and rock that could then be collected by the arm’s sampling head, which mission team members have likened to an older car’s air filter. We should expect OSIRIS-REx’s first images of the operation to start coming down levitra trial card to Earth tomorrow morning (Oct. 21), mission team members said.

The OSIRIS-REx team will spend the next week or so assessing how much asteroid material was collected. The probe’s handlers have expressed confidence that levitra trial card this first attempt will succeed. OSIRIS-REx’s sampler was designed to snag at least 150 grams (5.3 ounces) and could theoretically get up to 4 kilograms (8.8 lbs.) of material if everything went perfectly. But if OSIRIS-REx is deemed to have come up short on collected material today, another attempt could be made, levitra trial card at a backup site known as Osprey, as soon as January 2021.

A third try would be possible, too, if needed. The probe carries three bottles of surface-disturbing nitrogen gas. Those are contingency plans, levitra trial card however. If things went according to plan today, OSIRIS-REx remains on course to depart Bennu in March 2021.

The collected samples are scheduled to land here on Earth, encased in a special return capsule, in September 2023. Scientists will then study the material in labs around the world, scrutinizing the stuff in far more detail than OSIRIS-REx, or any other levitra trial card single probe, could do on its own in deep space. Asteroids are building blocks left over from the planet-formation epoch, so such analyses could reveal key insights about our solar system’s very early days, NASA officials have said. €œThis was an incredible feat—and today we’ve levitra trial card advanced both science and engineering and our prospects for future missions to study these mysterious ancient storytellers of the solar system,” said Thomas Zurbuchen, NASA’s associate administrator for science missions, in the NASA statement.

€œA piece of primordial rock that has witnessed our solar system’s entire history may now be ready to come home for generations of scientific discovery, and we can’t wait to see what comes next.” In addition, Bennu is rich in hydrated minerals and carbon-containing organic compounds. Asteroids like it may have helped Earth become habitable long ago, seeding our planet with the ingredients needed for life as we know it. €œAnd also, having the samples back here on Earth allows us to preserve them for future generations to come and allows for future explorers to analyze the samples using techniques and instruments that haven’t been levitra trial card invented, and to ask questions that we don’t even know to ask yet,” Lori Glaze, director of NASA’s Planetary Science Division, said during today’s webcast. Getting these samples down to Earth is OSIRIS-REx’s top priority.

But the mission also has other goals, as indicated by its full name—“Origins, Spectral Interpretation, Resource Identification, Security, Regolith Explorer.” For example, observations the probe has made while orbiting Bennu should help scientists better understand how asteroids move through space, NASA officials have said. This information could improve trajectory projections for levitra trial card potentially hazardous asteroids, a category that includes Bennu. (There’s a 1-in-2,700 chance that Bennu will hit Earth during a close approach in the late 2100s, researchers say.) OSIRIS-REx’s sample won’t be the first pristine asteroid material brought down to Earth by a space mission. Japan’s Hayabusa probe returned levitra trial card some grains of the stony asteroid Itokawa in 2010, and its successor, Hayabusa2, recently grabbed pieces of the carbon-rich rock Ryugu.

The material from Ryugu is scheduled to land on Earth this December. The OSIRIS-REx and Hayabusa2 teams have been working together for the past few years, and that collaboration will continue after the missions’ samples touch down on Earth, NASA officials have stressed. Copyright 2020 Space.com, levitra trial card a Future company. All rights reserved.

This material may not be published, broadcast, rewritten or redistributed..

Air conditioning and other http://medtech-radar.com/seroquel-cost/ cooling systems are canada levitra online widely recognized as integral to protecting people from the sometimes deadly impacts of extreme heat, which are intensifying in step with climate change. Yet according to a study, published yesterday in Nature Sustainability, there remains a “global blind spot” when it comes to handling the already exorbitant demand for cooling and indoor air conditioning, which alone is projected to triple by 2050. That’s a canada levitra online stark reality, the report warns, given that many cooling systems are carbon-intensive—and contribute to global warming themselves.

€œCooling is essential to human well-being and health, from the food we eat to the storage of medicine to how comfortable and productive we are at home, school or the office,” said report co-author Radhika Khosla, a principal investigator at the Oxford Martin Programme on the Future of Cooling. So if societies do not soon begin implementing sustainable cooling solutions, Khosla added in a statement, they risk “locking the world into a deadly feedback loop, where demand for cooling energy drives further greenhouse gas emissions and results in even more global warming.” The researchers examined thousands of peer-reviewed papers related to the United Nations’ Sustainable Development Goals and concluded that greener cooling systems could help achieve all 17 goals—which include curbing global hunger, reducing gender inequality and improving human health writ large. That’s possible, the report said, because extreme heat dramatically affects everything from canada levitra online food production to water quality to students’ ability to learn and focus during school.

Despite evidence that demonstrates the connection between efficient cooling systems and improved social and environmental outcomes, however, the authors argue that the “unprecedented rise in demand and the potential benefits of sustainable cooling” remain largely neglected in contemporary sustainability debates. That has major implications, they emphasized, for sustainable development around the canada levitra online world. To close that gap, the study said technological developments, innovative business models, intentional infrastructure and regulation could be used to make cooling more accessible—and climate friendly.

Cities and towns, for instance, could embed “passive and energy-efficient” cooling mechanisms in urban infrastructure to lessen the impact of extreme heat both indoors and outdoors. That could canada levitra online entail projects intended to reduce the prominence of “urban heat islands” by planting additional trees, developing new parks and building green roofs—all of which naturally cool urban spaces. Those strategies would be especially useful, the report said, given that “projections of the world’s population living in towns and cities are set to reach 66% by 2050,” making urban areas the “epicentre of cooling demand.” The authors also suggest that air-conditioning companies adopt a “cooling as a service” business model, intended to making sustainable cooling more affordable—especially in hot, low-income regions.

Rather than charging for the system itself, the companies would profit by retaining ownership of it and charging customers to operate the system and maintain a comfortable thermal environment. This would drive down, or even eliminate, what can be prohibitive upfront costs canada levitra online for cash-strapped households. In the context of a world “positioned at the brink of unprecedented cooling demand,” the report says, these interventions are among the many that offer “a way forward while being acutely aware of the extraordinary opportunity the current moment provides to use cooling as a lens to look to the sustainability of our future.” Reprinted from Climatewire with permission from E&E News.

E&E provides daily coverage of essential energy and environmental news at www.eenews.net.Tempers are canada levitra online running hot in science (as they are in the U.S. At large) as the field embarks on a long-overdue conversation about its treatment of women and people of color. In June, for example, thousands of researchers and academics across the globe—as well as the preeminent journals Science and Nature—stopped work for a day to protest racism in their ranks.

The American Physical Society endorsed the effort to “shut canada levitra online down STEM,” declaring its commitment to “eradicating systemic racism and discrimination” in science. Physics exemplifies the problem. African-Americans make up about 14 percent of the college-age population in the U.S., commensurate with their numbers in the overall population, but in physics they receive 3 to 4 percent of undergraduate degrees and less than 3 percent of Ph.D.s, and as of 2012 they composed only 2 percent of faculty.

No doubt there are many reasons for this underrepresentation, but one troubling factor is the refusal of some scientists canada levitra online to acknowledge that a problem could even exist. Science, they argue, is inherently rational and self-correcting. Would that canada levitra online were true.

The history of science is rife with well-documented cases of misogyny, prejudice and bias. For centuries biologists promoted false theories of female inferiority, and scientific institutions typically barred women's participation. Historian of science and MacArthur fellow Margaret Rossiter has documented how, in the mid-19th century, female scientists created their own scientific societies to compensate canada levitra online for their male colleagues' refusal to acknowledge their work.

Sharon Bertsch McGrayne filled an entire volume with the stories of women who should have been awarded the Nobel Prize for work that they did in collaboration with male colleagues—or, worse, that they had stolen by them. (Rosalind Franklin is a well-documented example of the latter. Her photographs of the crystal canada levitra online structure of DNA were shared without her permission by one of the men who then won the Nobel Prize for elucidating the double-helix structure.) Racial bias has been at least as pernicious as gender bias.

It was scientists, after all, who codified the concept of race as a biological category that was not simply descriptive but also hierarchical. Good scientists are open canada levitra online to competing ideas. They attend to challenging data, and they listen to opposing views.

But scientists are also humans, and cognitive science shows that humans are prone to bias, misperception, motivated reasoning and other intellectual pitfalls. Because reasoning is slow and difficult, we rely on heuristics—intellectual shortcuts that often canada levitra online work but sometimes fail spectacularly. (Believing that men are, in general, better than women in math is one tiring example.) It is not credible to claim that scientists are somehow immune to the biases that afflict everyone else.

Fortunately, the objectivity of scientific knowledge does not depend on the objectivity of individual canada levitra online scientists. Rather it depends on strategies for identifying, acknowledging and correcting bias and error. As I point out in my 2019 book, Why Trust Science, scientific knowledge begins as claims advanced by individual scientists, teams or laboratories that are then closely scrutinized by others, who may bring forward additional proof to sustain them—or to modify or reject them.

What emerges as a scientific fact or established theory is rarely if ever canada levitra online the same as the starting claim. It has been adjusted in light of evidence and argumentation. Science is a collective effort, and it works best when scientific communities are diverse.

The reason is canada levitra online simple. Heterogeneous communities are more likely than homogeneous ones to be able to identify blind spots and correct them. Science does not correct canada levitra online itself.

Scientists correct one another through critical interrogation. And that means being willing to interrogate not just claims about the external world but claims about our own practices and processes as well. Science has an admirable record of producing reliable knowledge about the natural and social world, but not when it comes to acknowledging canada levitra online its own weaknesses.

And we cannot correct those weaknesses if we insist the system will magically correct itself. It is not ideological to acknowledge and confront bias in science. It is ideological canada levitra online to insist science cannot be biased despite empirical validation to the contrary.

Given that our failings of inclusion have been known for a long time, it is high time we finally fix them.Young, healthy people will be intentionally exposed to the levitra responsible for erectile dysfunction treatment in a first-of-its kind ‘human challenge trial’, the UK government and a company that runs such studies announced on 20 October. The experiment, set to begin in January in a London canada levitra online hospital if it receives final regulatory and ethical approval, aims to accelerate the development of treatments that could end the levitra. Human challenge trials have a history of providing insight into diseases such as malaria and influenza.

The UK trial will try to identify a suitable dose of the levitra erectile dysfunction that could be used in future treatment trials. But the prospect of deliberately infecting people—even those at low risk of severe disease—with erectile dysfunction, a canada levitra online deadly pathogen that has few proven treatments, is uncharted medical and bioethical territory. Proponents of erectile dysfunction treatment challenge trials have argued that they can be run safely and ethically, and that their potential to quickly identify effective treatments outweighs the low risks to participants.

But others have raised questions about the safety and value of these studies, pointing out that large-scale efficacy trials involving tens of thousands of people are expected to deliver results on several erectile dysfunction treatments soon. €œDeliberately infecting canada levitra online volunteers with a known human pathogen is never undertaken lightly. However, such studies are enormously informative about a disease,” said Peter Openshaw, an immunologist at Imperial College London and investigator on the study, in a press statement.

€œIt is really vital that we move as fast as possible towards getting effective treatments and other treatments for erectile dysfunction treatment, and challenge studies have the potential to accelerate and de-risk the development of novel drugs and treatments.” Dose testing The planned erectile dysfunction treatment challenge study will be led by a Dublin-based commercial clinical-research organization called Open Orphan and its subsidiary hVIVO, which runs challenge trials canada levitra online on respiratory pathogens. It will take place in the high-level isolation unit of the Royal Free Hospital in north London, says Open Orphan executive chair Cathal Friel. The UK government’s erectile dysfunction treatment Taskforce has agreed to pay the company up to £10 million (US$13 million) to conduct the trial, with the possibility of contracting Open Orphan to run several more to test various treatments.

The UK Medicines and Healthcare Regulatory Agency (MHRA), which regulates clinical trials in the United Kingdom, and an ethical review committee, still need to approve the initial trial and canada levitra online its design, and that of future studies. The initial trial will involve an estimated 30–50 participants, says Andrew Catchpole, a virologist and the chief scientific officer at Open Orphan who is leading the work. It is canada levitra online open only to healthy adults aged 18–30.

The precise design of the study has not been finalized. But it is likely that a small number of participants will receive a very low dose of a erectile dysfunction ‘challenge strain’ derived from a currently circulating levitra and grown under stringent conditions. If none or few of the participants become infected, the researchers will seek canada levitra online permission from an independent safety monitoring board to expose participants to higher doses.

This process will be repeated until researchers identify a dose that infects most of those exposed, says Catchpole. Once an appropriate dose is identified, Open Orphan could be asked to run a series of challenge trials testing several treatments. Catchpole says canada levitra online that the design of these trials, including which treatments will be included, has not been determined.

He envisions that some trial participants will receive a placebo injection instead of a treatment, but he also says that head-to-head trials comparing two or more treatments could be run. Other treatment studies that the company runs typically enrol 40–50 volunteers for each trial arm, he canada levitra online says. Catchpole says that his team will take every precaution against participants in the initial trial developing severe disease.

Volunteers will be treated with an antiviral drug, such as remdesivir, once a nasal swab gives a positive result for erectile dysfunction genetic material. In addition to age and health, participants will be screened for canada levitra online risk factors that have been associated with severe erectile dysfunction treatment. Selecting participants at the lowest risk is the most important safety step in running a challenge trial, says Matt Memoli, an infectious-disease physician and virologist at the US National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, Maryland.

€œOnce you’ve given that levitra to the person, anything’s possible,” he says. €œYou can’t control it, you can canada levitra online only react to it.” If Open Orphan moves on to treatment trials, it will aim to recruit around 500 participants altogether, but Friel says the company will need to screen many times more people to identify suitable volunteers. An ethical review board will determine how to compensate participants.

Open Orphan typically pays volunteers around canada levitra online £4,000 for their time, says Catchpole. Ethical issues There is a concern that people will participate for the money without appreciating the risks, says Nir Eyal, a bioethicist at Rutgers University in New Brunswick, New Jersey, who has argued that erectile dysfunction treatment challenge trials can be run safely and ethically. But a well-designed online course, for instance, could ensure that participants understand the risks, he says.

Ensuring that participants understand the limitations of challenge trials will also be important, says Seema Shah, a bioethicist at Lurie Children’s Hospital and Northwestern University canada levitra online in Chicago, Illinois. With phase III trials of numerous erectile dysfunction treatments in the works, she thinks it unlikely that challenge trials will speed the development of the first treatments. Instead, their payoff could lie in helping to test later-generation treatments or laying the groundwork for fresh insights into the disease.

In this context, says Shah, “It becomes a little bit harder to justify them, and we need to take a close look at risks.” Meagan Deming, a treatment scientist and virologist at the University of Maryland School of Medicine in Baltimore, sees challenge trials canada levitra online as more appropriate for studying basic aspects of erectile dysfunction —such as the potential for re or how previous exposure to cold-causing erectile dysfunctiones influences susceptibility to erectile dysfunction treatment—than for vetting treatments. Because such trials are likely to involve only young, healthy people, they might not reveal much about how treatments could protect those most at risk of severe disease, such as older people and those with conditions such as diabetes, Deming says. €œThere’s a reason we canada levitra online don’t have a lot of treatments approved by challenge models, because they don’t apply to everyone and you want a treatment to protect almost everyone,” she says.

Phase III trials might not offer clear evidence of whether treatments work in older people, because of their low participation in those trials, says Peter Smith, an epidemiologist at the London School of Hygiene and Tropical Medicine who has been involved in challenge trials. Researchers will probably need to determine treatments’ likely effectiveness in older people, on the basis of how their immune systems respond to erectile dysfunction treatments before exposure to the levitra. And compared with field trials, challenge studies are better at identifying the types of immune response that canada levitra online predict whether a treatment is likely to work or not, adds Memoli.

Other trials The United Kingdom isn’t the only country investigating erectile dysfunction treatment challenge trials. Belgium’s government has committed €20 million (US$23.6 million) for facilities to host challenge trials, potentially involving erectile dysfunction treatment. NIAID is funding canada levitra online the development of two erectile dysfunction challenge strains by a lab at Colorado State University in Fort Collins, and a team led by Memoli is also laying the groundwork for such trials.

In a statement, NIAID said it was awaiting data from phase III studies before making decisions on erectile dysfunction treatment challenge trials. Proponents of the trials argue that the consequences of delaying them should be taken into account, alongside the risks of canada levitra online going forward. For instance, Eyal and economists Pedro Rosa Dias and Ara Darzi at Imperial College London have calculated that speeding up the development of erectile dysfunction treatments by one month would avert the loss of 720,000 years of life and prevent 40 million years in poverty, mostly in lower-income countries.

But Deming thinks that challenge trials should wait until their value is clearer and the risks can be better mitigated, for instance by deploying more potent therapies. €œWe don’t yet know canada levitra online enough about this disease to say for this person. You will not die,” she says.

€œWe’ve learned so much in the past nine canada levitra online months. In a year, we will be able to do this safely.” This article is reproduced with permission and was first published on October 20 2020.For the first time ever, a NASA probe has performed a sample-snagging operation on an asteroid in deep space. The agency’s OSIRIS-REx spacecraft spiraled down to the surface of the near-Earth asteroid Bennu this afternoon (Oct.

20) to grab material that mission team members hope harbors clues about the solar canada levitra online system’s early days and the rise of life on Earth. €œWe did it!. € OSIRIS-REx principal investigator Dante Lauretta, of the University of Arizona, said during a webcast that provided updates about today’s maneuver.

€œWe tagged the surface of the asteroid, and it’s up to Bennu now to see how the event went.” The goal was to collect at least 60 grams (2.1 ounces) of dirt and canada levitra online gravel from Bennu’s rubbly surface. It could take up to 10 days to determine if OSIRIS-REx achieved this aim, mission team members have said. And it’s not a disaster if the asteroid haul turns out to be a little canada levitra online light.

The probe can go back down for two more tries if need be. “This amazing first for NASA demonstrates how an incredible team from across the country came together and persevered through incredible challenges to expand the boundaries of knowledge,” NASA Administrator Jim Bridenstine said in a statement after the touchdown. €œOur industry, academic, and international partners have made it possible to hold a piece of the most ancient solar system in our hands.” Lauretta and his fellow OSIRIS-REx scientists and engineers watched over today’s asteroid sample-snatching attempt from a mission operations center at Lockheed Martin Space in Littleton, Colorado canada levitra online.

(Lockheed Martin built the spacecraft for NASA.) And while the mood was certainly jubilant, the impact of the ongoing erectile dysfunction treatment levitra was clear. For example, everyone wore facemasks and maintained appropriate social distancing for much of the event. While there were some hugs after news of OSIRIS-REx’s asteroid touchdown, they were few in NASA’s canada levitra online live webcast, with hand sanitizer clearly on hand after such celebrations.

“This is one of those moments where we’re all aware of erectile dysfunction treatment,” NASA astronomer Michelle Thaller of the Goddard Space Flight Center said in the webcast just after touchdown. €œBecause I want the hugs and the high fives and everything, but we’re all going to keep each other safe.” The $800 million OSIRIS-REx mission launched in September 2016 and arrived at canada levitra online the 1,640-foot-wide (500 meters) Bennu in December 2018. The probe has been taking the asteroid’s measure ever since, mapping its surface in incredible detail to prepare for today’s maneuver.

That work has revealed a world far more rugged than the mission team had expected. House-sized boulders stud Bennu’s surface, limiting the available options for canada levitra online a safe sample grab. The team eventually homed in on a small crater called Nightingale as its top choice, because the site sports relatively fresh and fine-grained material that hasn’t been exposed to the harsh deep-space environment for long.

But Nightingale is surrounded by hazards, including a big outcrop the mission team nicknamed “Mount Doom.” There are obstacles within the crater as well, so the spacecraft targeted a relatively flat, boulder-free area just 26 feet (8 m) wide—quite an ambitious goal, considering that OSIRIS-REx is the size of a 15-passenger van and the original mission plan envisioned a touchdown zone 165 feet (50 m) wide. €œSo, for canada levitra online some perspective. The next time you park your car in front of your house or in front of a coffee shop and walk inside, think about the challenge of navigating OSIRIS-REx into one of these spots from 200 million miles away,” Mike Moreau, OSIRIS-REx deputy project manager at NASA’s Goddard Space Flight Center in Greenbelt, Maryland, said during a news conference last month.

It currently takes more than 18 minutes for commands to travel from Earth canada levitra online to OSIRIS-REx, so Moreau and his colleagues cannot control the probe in real time. The craft therefore performed today’s operation autonomously. Shortly before 2 p.m.

EDT (1600 GMT) today, OSIRIS-REx fired its thrusters to get out canada levitra online of orbit around Bennu and head down toward the surface. At 6:12 p.m. EDT (2212 GMT), the probe “kissed” the asteroid for about 10 seconds with its sample-collecting canada levitra online mechanism, which is affixed to the end of OSIRIS-REx’s 11-foot-long (3.4 m) robotic arm.

During the brief touchdown, the spacecraft blasted Bennu’s surface with nitrogen gas. This stirred up dirt and rock that could then be collected by the arm’s sampling head, which mission team members have likened to an older car’s air filter. We should expect OSIRIS-REx’s first images of the operation to start coming down to Earth canada levitra online tomorrow morning (Oct.

21), mission team members said. The OSIRIS-REx team will spend the next week or so assessing how much asteroid material was collected. The probe’s canada levitra online handlers have expressed confidence that this first attempt will succeed.

OSIRIS-REx’s sampler was designed to snag at least 150 grams (5.3 ounces) and could theoretically get up to 4 kilograms (8.8 lbs.) of material if everything went perfectly. But if OSIRIS-REx is deemed to have come up short on collected material today, another attempt could canada levitra online be made, at a backup site known as Osprey, as soon as January 2021. A third try would be possible, too, if needed.

The probe carries three bottles of surface-disturbing nitrogen gas. Those are contingency plans, canada levitra online however. If things went according to plan today, OSIRIS-REx remains on course to depart Bennu in March 2021.

The collected samples are scheduled to land here on Earth, encased in a special return capsule, in September 2023. Scientists will then study the material in labs around the world, scrutinizing the stuff in far more detail than OSIRIS-REx, or any other single probe, could do on canada levitra online its own in deep space. Asteroids are building blocks left over from the planet-formation epoch, so such analyses could reveal key insights about our solar system’s very early days, NASA officials have said.

€œThis was an incredible feat—and today we’ve advanced both science and engineering and our prospects for future missions to study these mysterious ancient storytellers of the canada levitra online solar system,” said Thomas Zurbuchen, NASA’s associate administrator for science missions, in the NASA statement. €œA piece of primordial rock that has witnessed our solar system’s entire history may now be ready to come home for generations of scientific discovery, and we can’t wait to see what comes next.” In addition, Bennu is rich in hydrated minerals and carbon-containing organic compounds. Asteroids like it may have helped Earth become habitable long ago, seeding our planet with the ingredients needed for life as we know it.

€œAnd also, having the samples back here on Earth allows us to preserve canada levitra online them for future generations to come and allows for future explorers to analyze the samples using techniques and instruments that haven’t been invented, and to ask questions that we don’t even know to ask yet,” Lori Glaze, director of NASA’s Planetary Science Division, said during today’s webcast. Getting these samples down to Earth is OSIRIS-REx’s top priority. But the mission also has other goals, as indicated by its full name—“Origins, Spectral Interpretation, Resource Identification, Security, Regolith Explorer.” For example, observations the probe has made while orbiting Bennu should help scientists better understand how asteroids move through space, NASA officials have said.

This information could improve trajectory projections for potentially hazardous asteroids, a category that includes canada levitra online Bennu. (There’s a 1-in-2,700 chance that Bennu will hit Earth during a close approach in the late 2100s, researchers say.) OSIRIS-REx’s sample won’t be the first pristine asteroid material brought down to Earth by a space mission. Japan’s Hayabusa probe returned some grains of the stony asteroid Itokawa in 2010, canada levitra online and its successor, Hayabusa2, recently grabbed pieces of the carbon-rich rock Ryugu.

The material from Ryugu is scheduled to land on Earth this December. The OSIRIS-REx and Hayabusa2 teams have been working together for the past few years, and that collaboration will continue after the missions’ samples touch down on Earth, NASA officials have stressed. Copyright 2020 Space.com, a Future canada levitra online company.

All rights reserved. This material may not be published, broadcast, rewritten or redistributed..

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