Recommendations on recording harms in randomised controlled trials of behaviour change interventions, 2024, Papaioannou et al

BMJ 2024; 387 doi: https://doi.org/10.1136/bmj-2023-077418

Harms are possible from behaviour change interventions, such as the worsening of a health behaviour intended for change (rebound effect), improving a health behaviour but with subsequent worsening of another behaviour (risk compensation), and participants feeling targeted or stigmatised by an intervention. The processes and definitions originally designed to record harms within drug trials are typically followed to record harms in trials of behaviour change interventions owing to the lack of alternative guidance. Therefore, important harms could be missed in the evaluations of behaviour change interventions or irrelevant harms data may be recorded, leading to inefficiency. This paper presents evidence informed recommendations on how to record harms in randomised controlled trials of behaviour change interventions.

https://www.bmj.com/content/387/bmj-2023-077418.short?rss=1

 

Quote (my bolding)

1.3: Consider if anticipated harms are captured by the Good Clinical Practice definition of harm
Our qualitative study identified the current approach to recording harms in behaviour change intervention trials is driven by regulatory requirements and Clinical Trials Unit Standard operating procedures. This process involves defining harms as adverse events. An adverse event is any untoward medical occurrence in a patient or clinical investigation participant given a pharmaceutical product and that does not necessarily have to have a causal association with this treatment. Each adverse event is assessed for seriousness, expectedness, and relatedness to the intervention. A serious adverse event is an adverse event that at any dose results in death or is life threatening (ie, requires hospital admission or a prolongation of existing hospital stays, results in persistent or clinically significant disability or incapacity, or is a congenital abnormality or birth defect). This assessment identifies serious adverse reactions and suspected unexpected serious adverse reactions, with the second group of events being reportable to regulatory authorities according to strict timelines.

 

Everyone involved in those randomized non-controlled (no idea what they put that misleading term in the title) would assert that they have always done so. Bias is the root cause. They don't even believe in the outcomes they create unless they are favorable to them. And even then they seem to believe only as far as their need to figure out why they aren't getting better results, as they expect. They all think they have the correct answer, but only need to figure out how to get us to accept it. Same as it's always been.

So those people can't process harms and never will. They have no incentives to do so, are too biased and the lack of recording has always suited them because it's the only way they've been able to fake 'promising' results for decades. That they never delivered anything isn't considered a problem, because the very process of faking results isn't intended to produce results, only to prop up their dead ideology.

There is no such thing as self-regulation. This is the exact equivalent of allowing polluting industries to regulate themselves. Which they never do. Because it goes against their interests, and always the penalties whenever they are found, which is rarely, are only ever a tiny fraction of the gains they made by lying. And they always present themselves as the victims and always get most of their peers to defend them. It's all completely dysfunctional and unfit for purpose.

The entire format of evidence-based medicine is custom built to produce fake results and create abusive environments. This is a feature, not a bug. Otherwise 99% of their trials would be negative and they would have to radically change what they do. They all know this, that rigor invalidates them. Hence why every single published paper featuring randomized trials for behavioral interventions of Long Covid have been tiny pilot/feasibility studies with no controls and an excessive amount of bias. Every single one of them. There has never been a single rigorous high-quality study of this kind. Never. Even as they keep calling for it as a solution, but themselves only stick to methodologies that allow them to fake benefits.

Even though they are often 'testing' the most commonly used interventions out there, which hundreds of thousands have been subjected to. A number that would be millions if this treatment paradigm had any capacity to scale, but it doesn't, it will never be able to fulfil more than a tiny % of the demand. Because it's all fraudulent and deep down everyone involved knows that as soon as someone starts actually measuring things their whole scam is exposed. They don't want to know the truth. They want the comforting lies. Lies that comfort them and harm us. They are OK with that. It's all they know to do. They are completely out of their depth but too egomaniac to admit to decades of miserable lies and the systems behind this are too broken to care.

 

This entire paradigm is no different than "Theranos technicians using proprietary tests behind closed doors find Theranos technology amaze-ing". There is no independent validation. It's all a giant racket.

 

Looks like a useful paper for GET and CBT trials in ME/CFS.