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.)
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.
David Tuller, DrPH
Senior Fellow in Public Health and Journalism
Center for Global Public Health
School of Public Health
University of California, Berkeley