BMJ opinion. Virginia Minogue and Bill Wells: Patients and the public are essential to reducing research waste

https://blogs.bmj.com/bmj/2019/08/0...tm_term=&utm_content=SME&utm_campaign=editors

 

I have submitted a short response to this blog. I'm posting and storing it here because I have a bad feeling that it will not appear:

"As a patient who follows research into myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) closely, I can only agree with the recommendations of Minogue and Wells. For more than two decades, research into ME/CFS has relied on randomized trials that are not blinded and focus on subjective outcomes. This means that therapists know which group is receiving the intervention, possibly transmitting their expectation of treatment effects to their patients. Without blinding and objective outcomes, it is difficult to know whether changes in how participants fill in questionnaires constitute clinical improvement or weaknesses in trial design. The result of this has been the promotion of controversial rehabilitative interventions for ME/CFS that are contested by patient organizations. I believe that if patients had been more involved in trials design and prioritisation of research, these methodological concerns would have been studied into more detail. The reports about the possible harms of rehabilitative interventions would have been taken more seriously and research waste could have been greatly reduced."

 

Thanks for taking the time to respond, Michiel. I guess this is just a typo but it should be “Without blinding or objective outcome measures.” As I’m sure you appreciate, blinded trials with subjective outcome measure are fine, as are unblinded trials with objective outcome measures.

I don’t know if they would let you change it, if published, but it’s quite important IMO.

 

"I believe that if patients had been more involved in trials design and prioritisation of research"

Unless it was fools like Sir Peter Spencer from Action for ME!

 

Yes that would be a more adequate description of what I've meant, thanks.

Although now that you've raised the issue, I think that many 'objective' outcomes are simply less prone but not immune to these biases. If patients get the feeling that they are receiving the intervention/control they might be more/less inclined to do their best for example on steps per day, fitness/walking tests etc.

 

Yes, I realize that. But I believe that if it was common practice to involve patients in research design and research priorities things would have gone quite differently in ME/CFS. I suspect the focus would be on rigorous testing of the safety and efficacy of GET/CBT rather than comparing GET with GAT or coming up with more cost-effective versions.