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Is an unfinished pilot study of 8 patients really newsworthy?

Rating

3 Star

Categories

A Surgery-Free Fix for Bad Knees?

Our Review Summary

This story reports on incomplete results from an ongoing trial of a procedure to treat arthritis pain by injecting microparticles into blood vessels around the knee.

The data — from just eight patients — were presented at the Society of Interventional Radiology’s annual meeting.  While story does some things well, overall this was a tiny, short-term, unfinished study that doesn’t seem ready for a wide consumer audience.

 

Why This Matters

Osteoarthritis of the knee is very common, causing symptoms in 13% of women and 10% of men over 60 in the U.S. It’s a leading cause of disability, due to pain, and many of the treatment options aren’t great.

Efforts such as this one to identify new treatments are important. The challenge is that these are preliminary results of a new first time treatment in a small number of individuals presented in a short abstract at a research meeting. The amount of improvement reported sounds great, but often, this information may overstate what subsequent research shows. From this limited presentation, it isn’t really clear yet how the treatment works, how long it works for, how often it may need to be done, what its side effects are in the short-term and more importantly with long-term use. It also isn’t all that clear what exactly is being done in terms of the procedure itself. This is common with such early presentations at a meeting where the researcher only gets a short time to describe the findings, and that raises the importance of waiting for a full publication of results with more patients and longer term follow-up. Even if that work continues to show promise, further studies that may take several years are needed before patients who may benefit from this treatment may expect to see it approved for general use.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

Although it may be too early to nail down an exact price, the topic of how much this might cost wasn’t broached at all, nor were the costs of currently available treatments.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Satisfactory

The story passed muster by saying patients studied so far “averaged a 58-point decrease in pain, as measured on a 100-point visual scale used to estimate pain,” starting from an average baseline of 72. It said that meant pain was “brought down to manageable levels.”

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

The story quoted the lead researcher saying “there were no adverse events related to this treatment” and no side effects were expected because the procedure “only blocks additional blood flow to the knee, rather than cutting it off altogether.”

In a preliminary study such as this with almost no follow-up, we think the above statement is inappropriate. There is so little known about it to say “no side effects are expected” is hubris, and the story should have pointed that out.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The story repeatedly flagged the preliminary nature of these findings. That’s good.

However, it didn’t point out one very important detail: There was no control or placebo group. This lowers the evidence quality substantially, as the placebo effect could be at play here.

Does the story commit disease-mongering?

Satisfactory

The story didn’t engage in disease-mongering. While some data on the prevalence of knee pain would have been useful, the story does provide a link to the Arthritis Foundation.

Does the story use independent sources and identify conflicts of interest?

Satisfactory

The story stated that Boston Scientific, maker of the microparticles, funded the study.

It also had one independent source, Suresh Vedantham, MD, a professor of radiology and surgery at the Mallinckrodt Institute of Radiology at Washington University in St. Louis. We did not detect any conflicts of interest.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story mentions joint replacement and medications to reduce knee pain. However, it doesn’t mention steroids, hyaluronic acid, plasma protein derivatives, physical therapy and less invasive surgical procedures. The point is that there are a number of options, none particularly good, but readers should be aware that they exist and are used.

Does the story establish the availability of the treatment/test/product/procedure?

Not Satisfactory

The story does acknowledge the need for further research. But this is a bit of an extreme case, in terms of how preliminary the research is, and so we feel the story should have made it very, very clear that we have no idea how this will pan out. Another more skeptical source would have helped on this one.

Does the story establish the true novelty of the approach?

Satisfactory

The story stated that this is the “first U.S. clinical trial” of this procedure.

Does the story appear to rely solely or largely on a news release?

Satisfactory

The story does not appear to rely on a news release.

Total Score: 5 of 10 Satisfactory

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