NOTE TO READERS: When this project lost substantial funding at the end of 2018, I lost the ability to continue publishing criteria-driven news story reviews and PR news release reviews - once the bread-and-butter of the site going back to 2006. The 3,200 archived reviews, while still educational, are getting old and difficult for me to technically maintain on the back end of the website. So I am announcing that I plan to remove these reviews from the site by April 1, 2021. The blog and the toolkit - two of the most popular features on the site - will remain. If you wish to peruse the reviews before they disappear, please do so by the end of March 2021. After that date you may still be able to access them via the Internet Archive Wayback Machine - https://archive.org/web/.
Read Original Story

A balloon instead of a knife: Sinuplasty for ailing sinuses

Rating

4 Star

A balloon instead of a knife: Sinuplasty for ailing sinuses

Our Review Summary

This story provides a good balance of information on a new treatment option for chronic sinusitis, and there is corroboration with otolaryngologists not affiliated with the makers of the balloon device who are able to provide perspective on the procedure. The story clearly notes this procedure would be for chronic, not acute sinusitis and describes how these are different. The story explains that this form of sinuplasty is not for everybody, and that it may not prevent the need for more comprehensive surgery in which bone and inflamed tissue are removed to open the sinus passages. More information is needed on the safety and efficacy of balloon sinuplasty, and no one knows if this surgery works as well as traditional surgery for chronic sinusitis.

The story mentions other options for treating chronic sinusitis, including medication and sinus surgery, which is described as highly effective, but with a painful recovery and side effects such as scar tissue. Quantification of the incidence of side effects with traditional surgery would be useful.

While there is not much quantitative evidence available on the new procedure, the story stresses the importance of a randomized trial underway comparing medication, traditional sinus surgery and the newer balloon sinuplasty. There is adequate description of this trial and the need for further evidence before this new procedure can be widely recommended. There is a caveat that this procedure should not have been FDA approved with so little quality evidence: a study of 10 people that found “no safety concerns”, but readers should be told more about this very small group. What were the long term outcomes and did these patients eventually have to undergo further sinuplasty, more invasive surgery or continue to take medications to relieve their chronic sinusitis? The story explains that general anesthesia is still needed for the balloon procedure and this comes with its own set of health risks and additional costs.

There is no mention of the cost of this newer procedure. This is important information if the surgery is not a permanent fix for chronic sinusitis. A cost comparison of the newer sinuplasty, which may require repeated operations, sinus medications and traditional surgery is needed.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

No mention of the cost of treatment. This is important if the surgery is not a permanent fix for acute sinusitis. Repeated operations and continued medications need to be compared to cost for traditional surgery.

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

Not Satisfactory

No quantitative estimate of the benefits of the new procedure. There was a study of 10 people that found “no safety concerns”, but readers should be told more about this very small group. What were the long term outcomes and did these patients eventually have to have further sinuplasty, more invasive surgery or continue to take medications to relieve sinusitits? The story mentions that a larger, randomized trial is underway to better understand the risks and benefits of sinuplasty compared to medication and traditional sinus surgery.

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

Satisfactory

Mentions that more information is needed and no one knows if balloon sinuplasty works as well as the more traditional surgical option for chronic sinusitis. Mentions that general anesthesia is still needed for balloon procedure and this comes with its own set of health risks.

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

Satisfactory

There isn’t much evidence for the story to report. The story did stress the importance of a randomized trial underway comparing medication, traditional sinus surgery and the newer balloon sinuplasty. Story describes this trial and the need for further evidence before this new procedure can be widely recommended. Mentions that this procedure should not have been FDA approved with so little quality evidence.

Does the story commit disease-mongering?

Satisfactory

No evidence of disease mongering. The story mentions that this procedure would be for chronic, not acute sinunitis and describes how these are different.

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

Satisfactory

Good balance of information on treatment options with input from otolaryngologists not affliated with the makers of the device who are able to provide perspective on the new procedure. They mention that further study is needed. There is a note that one of the physicans studying the new sinuplasty has no financial ties to Acclarent, maker of the balloon devices used in this type of sinuplasty.

Does the story compare the new approach with existing alternatives?

Satisfactory

Mentions that this form of sinuplasty is not for everybody and that it may not prevent the need for more comprehensive surgery in which bone and tissue are removed. There is mention of other options including medication and the more traditional surgery, which is decribed as highly effective, but with a painful recovery and side effects such as scar tissue. Quantification of the incidence of this and other side effects of traditional surgery would be useful.

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

Satisfactory

The story is clear that the FDA approved the device but that it still needs to undergo further study via randomized controlled trials.

Does the story establish the true novelty of the approach?

Satisfactory

Story mentions that this is a new procedure only offerred by 100 doctors.

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

Satisfactory

This story is a blananced presentation of sinuplasty and the information here does not appear to be from a press release. The are quotes from otolaryngologists not affliated with the makers of the device who are able to provide perspective on the new sinuplasty procedure.

Total Score: 8 of 10 Satisfactory

Comments

Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.