06Jun

A Red Cross plea last month for blood donors averted what the agency described as a shortage so severe some hospitals were only days from running out of blood.

So many volunteers stepped forward that the Red Cross now deems the supply “adequate.” “We say that cautiously, because we don’t know what will come,” Paul Sullivan, senior vice president of the American Red Cross told the Washington Post.

Now, besides continuing to urge healthy people to give blood, hospitals and blood banks are asking those who have recovered from COVID-19 to donate plasma.

In the tri-state area, the New York Blood Center and Mount Sinai Hospital have issued calls for recovered COVID-19 persons to donate.

“If you had #COVID19 and have recovered you can help save a life. Your blood may contain antibodies that fight the virus and can help critically ill people. Please fill out this form to see if you are eligible to be a volunteer: https://bit.ly/2vTHALk,” the hospital Tweeted.

Friday, the Food and Drug Administration approved plans to test two potential therapies derived from human blood. “These are called convalescent plasma and hyperimmune globulin and are antibody-rich blood products made from blood donated by people who have recovered from the virus,” the FDA said.

The FDA program supplements the National COVID-19 Convalescent Plasma Project, an ad hoc effort organized by physicians and scientists across the country to investigate using convalescent plasma against the coronavirus. The project developed guidelines for using plasma and has detailed information for potential donors and Covid-19 patients.

Before the FDA acted, some of the researchers in the project were independently testing the antibody-rich plasma on a handful of seriously sick patients. It’s too soon to know the outcome, but initial reports suggest the therapy may be lessening their symptoms.

Using blood and plasma from recovered patients goes back more than 100 years. Before antibiotics, it was one of the only therapies available. It was sufficiently successful that it’s been used to treat other types of diseases such as SARS and Ebola. Though clinical studies of the therapies are few, a detailed analysis published in 2014 in The Journal of Infectious Diseases concluded, “Convalescent plasma may reduce mortality and appears safe.”

Meanwhile, blood banks across the country are looking to healthy, uninfected individuals to make up for the cancellation of blood drives, which provide about 80% of the nation’s blood supply. There’s still a need for blood, even though demand has lessened as elective surgeries are postponed and accidents and traumatic injuries have declines with fewer people driving.

At Ohio’s Cleveland Clinic, which conducted its own blood drive, emergency physician Baruch Fertel said that as long as donations continue, “We can stay out of trouble. But we’re not out of the woods. Folks who are healthy and recovered should consider giving blood.”

Photo by Testalize.me on Unsplash

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Jun 6, 2023

Is It the Drug Or Fitbit Making the Difference?

As if clinical researchers and managers didn’t already have enough to worry about, now add activity trackers to the list.

Smartwatches, Fitbits and similar trackers have the potential to influence behavior, which matters in studies where physical activity is a study endpoint. (An endpoint in a clinical study is an event used to objectively measure the effect of a drug or other intervention.)

If the level of activity is an endpoint in a study of, say, a drug to improve fatigue, researchers need to be able to say that it is the drug that has made the difference. But anyone who has ever used a Fitbit or other activity tracker know how engaging – addicting, even – they can be. They prod you to get in that 10,000 steps with encouraging messages like, “Only 789 steps to reach your goal.”

As an article on the Clinical Research News website says, “Use of the devices could result in ‘activity peaks’ and ‘activity plateaus’ driven not by drug efficacy but as a response to the smartwatch/fitness tracker targets.”

In other words, who’s to say the increased physical activity was the result of the drug or the tracker prodding?

Before commercial trackers became so ubiquitous, researchers gave study volunteers devices that accumulated the data, but without making it visible to them. Commercial trackers make everything visible.

Besides simply counting steps, sophisticated wearables measure all sorts of activity related variables like heart rate, duration, intensity, distance, sleep and more. Because participants in studies of physical activity are able to see this data they can skew the results by working to reach targets and earn badges.

The authors of the article – “The Potential Of Activity Trackers To Bias Study Results” – suggest a number of measures researchers can take to mitigate the influence of these devices including prohibiting participants from wearing them, establishing baseline physical activity levels and choosing endpoints less likely to be influenced by the trackers.

Ultimately, the writers say, “Additional research is needed in this arena… More certain is that the unblinding of study data could have far-reaching if unintended consequences by introducing bias into the data analysis process.”

Photo by Andres Urena on Unsplash

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