By David Tuller, DrPH
In the past week, I have written three posts about a Norwegian study of cognitive behavior therapy plus music therapy for adolescents with chronic fatigue after acute Epstein-Barr virus infection–an illness known as mononucleosis in the US and glandular fever in the UK. The corresponding author of the study is Vegard Bruun Wyller, a professor at the University of Oslo’s Institute of Clinical Medicine.
Professor Wyller is also involved with a planned Norwegian trial of the Lightning Process, which has stirred up controversy and led to misinformed coverage in Dagbladet, a major news organization. On Thursday, I sent a letter to Professor Wyller inviting him to respond to my concerns on Virology Blog.I have posted the first letter below.
I also sent a letter to Dagbladet in which I noted, among other things, that the reporter forgot to include my Berkeley position and academic credentials. I will give the news organization a bit of time to publish the letter before posting it myself.
**********
Dear Professor Wyller–
I am an investigative journalist and an academic fellow at the School of Public Health at the University of California, Berkeley. I frequently write about research in the domains of CFS, ME and other so-called medically unexplained symptoms. Much of my work appears on Virology Blog, a science site hosted by Professor Vincent Racaniello, a microbiologist at Columbia University. (I have cc’d Professor Racaniello on this e-mail.)
I have now written three Virology Blog posts that are critical of a recently published study on cognitive behavior therapy combined with music therapy as a treatment for adolescents with chronic fatigue following acute Epstein-Barr virus infection. Since you are the corresponding author, I wanted to offer you an opportunity to respond to my concerns. If you send me your comments, at any length you choose, I will post them in full on Virology Blog, without editorial interruption from me. (I will likely respond to your comments, but in a completely separate post.)
The three Virology Blog posts about the study are here, here and here.
As mentioned, I will post whatever you care to send. However, I’d be particularly interested in answers to the following questions:
- Why did the paper describe the research as a feasibility study without disclosing that it started as a small but fully powered randomized trial?
- Why did the conclusions in the abstract and full text not mention the poor results for the primary outcome?
- Why was PEM presented as an outcome when it wasn’t mentioned in the protocol, registration, and statistical analysis plan?
- Why was the outcome of “recovery” not mentioned in the registration and statistical analysis plan?
- Why was it possible for participants to get worse on the objective primary outcome but still be deemed to have achieved “recovery” in the trial based on results for a subjective secondary outcome?
- Given the high attrition rate in the intervention group, why did the paper highlight the per protocol analysis of “recovery” while providing intention-to-treat analyses of other outcomes?
- Were you concerned that one reviewer read only the abstract, and were you surprised the editors chose not to obtain a review of the actual paper instead?
- Do you know if the editors and/or peer reviewers checked the trial protocol, registration and statistical analysis plan?
Thank you, Professor Wyller. I look forward to hearing from you.
Best–David
David Tuller, DrPH
Senior Fellow in Public Health and Journalism
Center for Global Public Health
School of Public Health
University of California, Berkeley
Comments are closed.