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Myths busted: New studies show telemedicine is effective, doesn’t reduce access to care

Common concerns about telemedicine don’t hold up to scrutiny, a first-of-its-kind study highlighting telemedicine’s remarkable effectiveness concludes….

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Common concerns about telemedicine don’t hold up to scrutiny, a first-of-its-kind study highlighting telemedicine’s remarkable effectiveness concludes.

Credit: University of Rochester Medical Center

Common concerns about telemedicine don’t hold up to scrutiny, a first-of-its-kind study highlighting telemedicine’s remarkable effectiveness concludes.

The paper is one of two studies on telemedicine by University of Rochester Medical Center (URMC) researchers appearing this week in NEJM Catalyst. The second study demonstrates the success of URMC’s effort to provide mental health services to nursing homes via a hybrid model that includes telemedicine.

“For patients, the message is clear and reassuring: Telemedicine is an effective and efficient way of receiving many kinds of health care,” said Kathleen Fear, Ph.D., lead author of the first paper, “Busting Myths about the Impact of Telemedicine Parity,” and director of data & analytics at the UR Health Lab. “Especially for those with transportation challenges, it is a service that really fills a gap – and, vitally, it does not compromise the quality of the care that patients receive.”

Fear and her co-authors used data generated in part by the COVID pandemic, when health care providers across the nation rapidly expanded their telemedicine services, to examine three specific concerns about telemedicine:

  • That it will reduce access to care for the most vulnerable patients who may be unable to access digital services.
  • That reimbursing providers for telemedicine services at the same rate as traditional services will encourage telemedicine overuse.
  • That telemedicine is not an effective way to provide care.

“We really dug into the data, and it disproved all three concerns, which is really quite exciting,” Fear said. “Not only did our most vulnerable patients not get left behind—they were among those engaging the most with, and benefitting the most from, telemedicine services. We did not see worse outcomes or increased costs, or patients needing an increased amount of in-person follow up. Nor did we find evidence of overuse. This is good care, and it is equitable care for vulnerable populations.”

Michael Hasselberg, Ph.D., RN, URMC’s chief digital health officer and the study’s senior author, said the paper marks the first time anyone has published comprehensive data refuting the three myths, whose persistence has limited the adoption of telemedicine nationwide. URMC researchers were in a unique position to undertake the study because of the work of more than 3,000 providers across the health system who engage in telemedicine and the UR Health Lab’s ability to analyze the data generated by their work.

The researchers compared data from July to December of 2020, a period of relative normalcy after the pandemic’s first surge, to pre-pandemic data from July to December of 2019, using data from January to June 2021 as a follow-up period. Their analysis encompassed a review of patient demographics, outcomes, provider use, visits completed and more.

“For our providers, a major concern about telemedicine has always been, ‘What might I miss if I can’t sit in the room with the patient?’” Fear said. “But we simply didn’t find any increase in negative outcomes. This doesn’t mean telemedicine will replace in-person care, but it’s clear that it can help people access care more consistently and comfortably and that it provides a highly effective complement to traditional care.”

The second NEJM Catalyst study looked at a program URMC physicians developed to bring psychiatric and psychotherapeutic resources to nursing home patients through a combination of telehealth, on-site visits and staff education. The researchers concluded that the program improved access to care and reduced the number of residents requiring anti-psychotic medication.

“With a small team that we assembled here at URMC, we’ve been able to have a huge reach, extending care to patients in parts of the state where high-quality mental health services are scarce at best,” said Adam Simning, M.D., Ph.D., assistant professor of Psychiatry and the study’s lead author. “At a time when nursing homes nationwide are severely understaffed, and the need for mental health services among their residents is increasing, we’ve efficiently redesigned the way mental health services are provided to the more than 50 nursing homes we work with.”

Hasselberg, who was also a senior author on the nursing home study, believes both papers will resonate in the medical community, encouraging payors and policymakers to continue and expand pandemic-era policies that make the growth of telemedicine services possible.

“Hopefully, what we’ve learned here will help the rest of the country and help shape the future of health care as telemedicine becomes increasingly prominent,” said Hasselberg. 

Carly Hochreiter, a senior analyst with the UR Health Lab, was an additional author on the telemedicine myths paper. Additional URMC authors on the nursing home study were psychiatry resident Zhi-Yang Tsun, M.D., Ph.D.,, Elizabeth Santos, M.D., associate professor of Psychiatry, and Lara Press-Ellingham, senior health project coordinator.


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Revive Therapeutics To Re-Apply For Primary Endpoint Change With The FDA

Today, Revive Therapeutics Ltd. (CNSX: RVV) (OTCMKTS: RVVTF) provided an update to investors pertaining to its current Phase 3 clinical trial to evaluate…

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Today, Revive Therapeutics Ltd. (CNSX: RVV) (OTCMKTS: RVVTF) provided an update to investors pertaining to its current Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine to treat COVID-19. If the desired outcome is successful, it could remediate last week’s FDA decision and set the trial on a positive trajectory once again.

Following the company’s recent submission of amended protocol to the FDA—in which endpoints related to time to resolution using the polymerase chain reaction (PCR) test was not accepted—Revive Therapeutics has charted a different path.

It now will submit a revised primary efficacy protocol assessing the difference between participants with at least two clinical improvements in symptoms of COVID-19 at Day 14, compared with baseline between Bucillamine versus placebo. Time to resolution via PCR test now becomes a secondary endpoint—among others—instead of the primary. Ultimately, Revive gets another shot at approval through better refinement and optimization of new endpoint protocols.

Endpoint change sought be Revive Therapeutics to a symptoms focus from hospitalization/death remains in play

Should the FDA agree with the revised protocol, the company’s Data Safety Monitoring Board (DSMB) will review the post-dose data compilation of approximately 500 subjects in the context of the new primary endpoint. From there, the committee shall offer one of several possible courses of action:

• Make a recommendation on continuing the study by enrolling additional patients

• Advise on halting the study early due to positive efficacy showing statistical significance

• Recommend halting the trial due to lack of safety and/or efficacy

Revive expects to submit the revised protocol sometime next week.

In response to today’s news, shares of Revive Therapeutics partially reversed the big-volume downside move experienced on September 28. RVV rallied +47.62% to $0.31 per share on the Canadian Stock Exchange, as traders bought the recent discount given that FDA endpoint approval is still very much in-play.

TDR will have further coverage as warranted.

The post Revive Therapeutics To Re-Apply For Primary Endpoint Change With The FDA appeared first on The Dales Report.

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Hundreds Of Thousands Of Americans Sought Medical Care After COVID-19 Vaccination: CDC Data

Hundreds Of Thousands Of Americans Sought Medical Care After COVID-19 Vaccination: CDC Data

Authored by Zachary Stieber via The Epoch Times…

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Hundreds Of Thousands Of Americans Sought Medical Care After COVID-19 Vaccination: CDC Data

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

Hundreds of thousands of Americans sought medical care after getting a COVID-19 vaccine, according to Centers for Disease Control and Prevention (CDC) data released on Oct. 3.

The Center for Disease Control (CDC) headquarters in Atlanta, Ga., in a file photograph. (Jessica McGowan/Getty Images)

Some 782,900 people reported seeking medical attention, emergency room care, and/or hospitalization following COVID-19 vaccination. Another 2.5 million people reported needing to miss school, work, or other normal activities as a result of a health event after getting a COVID-19 vaccine.

The reports were made to the CDC’s V-safe program, a new vaccine safety monitoring system to which users can report issues through smartphones.

The CDC released the data to the Informed Consent Action Network (ICAN) after being sued over not producing the data when asked by the nonprofit. ICAN posted a dashboard summarizing the data.

It took numerous legal demands, appeals, and two lawsuits, and over a year, but the CDC finally capitulated and agreed to a court order requiring them to do what they should have done from day one, release the V-safe data to the public,” Aaron Siri, a lawyer representing ICAN in the case, told The Epoch Times in an email.

About 10 million people utilized V-safe during the period of time the data covers: Dec. 14, 2020, to July 31, 2022. About 231 million Americans received at least one vaccine doses during that time.

The V-safe users reported about 71 million symptoms.

The most commonly reported symptoms were chills (3.5 million), swelling (3.6 million), joint pain (4 million), muscle or body aches (7.8 million), headache (9.7 million), fatigue (12.7 million), and general pain (19.5 million).

About 4.2 million of the symptoms were of severe severity.

Users of V-safe filled in data for about 13,000 infants younger than two, reporting over 33,000 symptoms, including pain, loss of appetite, and irritability.

The data produced so far by the CDC does not include free-text responses, according to ICAN. The data covered fields where users checked boxes.

ICAN, founded by film producer Del Bigtree, said that the newly revealed data “reveals shocking information that should have caused the CDC to immediately shut down its COVID-19 vaccine program,” citing the percentage of people who reported needing to get care or missing school, work, or other normal activities, as well as the reported adverse events.

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Tyler Durden Thu, 10/06/2022 - 18:20

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Government

Washington Gave $28M To Chinese Entities For Joint Research Since 2015: Report

Washington Gave $28M To Chinese Entities For Joint Research Since 2015: Report

Authored by Rita Li via The Epoch Times (emphasis ours),

Recently…

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Washington Gave $28M To Chinese Entities For Joint Research Since 2015: Report

Authored by Rita Li via The Epoch Times (emphasis ours),

Recently released findings show U.S. government agencies sent over $28 million in taxpayers’ dollars “directly to Chinese entities” for joint research over a five-year period ending 2021.

A technician works at a DNA tech lab in Beijing on Aug. 22, 2018. (Greg Baker/AFP/Getty Images)

From fiscal years 2015 through 2021, “the CDC [Centers for Disease Control and Prevention], NIH [National Institutes of Health], and DOD [Department of Defense] provided 22 awards totaling $28.9 million directly to Chinese entities including universities and other research institutions,” the Government Accountability Office (GAO) said on Sept. 29 following a trove of analyses.

Researchers found the federal funding focused on “multiple scientific disciplines,” aiding Chinese entities in conducting research on “disease surveillance, vaccination studies, and the development of new drugs,” as well as “alternative technologies to propel vehicles such as drones.”

The release of its 38-page report (pdf) follows a January request from House Republican Conference Chairwoman Elise Stefanik (R-N.Y.) and Michael McCaul (R-Texas), the top Republican on the House Foreign Affairs Committee. They asked GAO to review federal funds provided to China or entities controlled by the Chinese Communist Party (CCP) for collaborative research, and U.S. contributions to multilateral institutions.

Stefanik described such funding as “troubling.”

“China’s deception and stonewalling of the truth behind the origins of COVID-19 has led to millions of senseless deaths and trillions of dollars in economic destruction across the globe,” the congresswoman said in a statement to The Epoch Times.

The three agencies awarded a total of 13 Chinese entities for joint publications, information sharing, and workshops, while 84 percent of the direct funding went to the University of Hong Kong, Peking University, and the Chinese Center for Disease Control and Prevention, known as the Chinese CDC.

Receiving almost $5 million from the NIH and the CDC over the past years, the Chinese CDC had been suppressing information about the outbreak domestically and snubbed U.S. offers of assistance, despite how any health data would have been crucial to formulate a more effective COVID-19 containment strategy and minimize the disease’s global spread.

Health workers wearing personal protective equipment walk on a street in a neighborhood during a COVID-19 lockdown in the Jing’an district in Shanghai on April 8, 2022. (Hector Retamal/AFP via Getty Images)

“Even more frightening,” Stefanik continued, “we still have no idea how much total money has been sent to China due to lax reporting requirements. Make no mistake, the Chinese Communist Party’s deception throughout the pandemic confirmed that China is not a reliable partner.”

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Tyler Durden Thu, 10/06/2022 - 17:40

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