A charter to improve ME/CFS research

[Hoopoe]

Emphasis on PEM is also important. That means designing studies that measure after exertion, or symptoms over time, or before and after exertion, or make a comparison between PEM and non-PEM participants. This seems to make it easier to find abnormalities and those that are relevant to PEM, which is consistently ranked as one of the biggest problems for patients.

 

[Peter T]

True, but the Crawley LP trial happened, and I assume had her tame fan club as her patient/carer group approving, and an ethics committee approving it. There needs to be a stronger system that disallows trials that include persuasion to ignore physical symptoms.

I am half remembering from somewhere a useful wording that indicated the need for patient involvement in planning but how to avoid a tame user group or charity with close links to the researcher(s). It was something about using a national charity or several charities/groups to ensure a voice representing the broader patient perspective.

I thought when I read it that was a useful wording, but then completely forgot what or where. Could it have been in discussion here related to the Norwegian LP research?

 

[NelliePledge]

Trying to do as much as possible at the person’s home - the work the Biobank and Physios for ME doing sets an example

 

[Peter T]

Trying to do as much as possible at the person’s home - the work the Biobank and Physios for ME doing sets an example

Is the issue that any research needs to involve some evaluation of subjects total activity level during the research process?

This is in relation to both meaningful outcome measures and selection bias. Participation in research has energy costs such that we end up with the act of measuring potentially distorting what is being measured. Further only seeing subjects in clinical settings is in effect a source of selection bias as only mild and moderately impaired patient will be able to participate.

 

[Hutan]

I am half remembering from somewhere a useful wording that indicated the need for patient involvement in planning but how to avoid a tame user group or charity with close links to the researcher(s). It was something about using a national charity or several charities/groups to ensure a voice representing the broader patient perspective.

A while back, I suggested to Australia's National Health and Medical Research Council (the government organisation that distributes funds for medical research) that they require that every research proposal be endorsed by a patient advocacy group. Each endorsement should set out why the research is needed and how the researchers have worked with patients previously and on the proposal. And, the quality of that endorsement would be rated as part of the evaluation process.

That way, projects that are endorsed by a credible patient advocacy group with a lot of members score would better on the 'patient support' measure than one endorsed by an ad hoc group, one where the participants have been chosen by the researcher.

 

[Barry]

8) Publish your data, not just the results
Researchers should make the raw data and statistical analyses publicly available in a way that ensures the anonymity and privacy of study participants. Publishing full datasets enables others to check publications for errors or conduct additional analyses. It also ensures a lasting impact of a study because the individual patient data can be used in future meta-analyses. Scientific studies are often expensive and require big efforts from ill patients. Withholding valuable information from these studies blocks scientific progress and should be viewed as lamentable, regardless of current norms on sharing data in the scientific community.

Totally agree with this. Especially important that a trial's database be designed with this as one of its primary requirements at inception, then it will be no big deal to achieve in practice. The requirement for this should be part of the protocol I would have thought, so that a trial cannot get past first base unless taken fully onboard.

 

[Barry]

True, but the Crawley LP trial happened, and I assume had her tame fan club as her patient/carer group approving, and an ethics committee approving it. There needs to be a stronger system that disallows trials that include persuasion to ignore physical symptoms.

Yes. Where the hypothesis presumes a psychological reason for that condition, it must not be assumed there is no physiological reason unless already previously positively proven independently with high confident that there is no physiological reason.

The purpose of the trial is to assess the viability of its hypothesis, so the trial's methodology must not presume the validity of its own hypothesis in pursuance of proving its hypothesis! e.g. PACE hypothesis based on psychological shortcomings being the reason physical deconditioning not reversed. Yet during the trial if physical symptoms not improved, or worsened, attributing this as failure to overcome psychological shortcomings, totally ignoring possibility of real physical implications.

 

[Sean]

Good thread, @Michiel Tack

Besides the standard stuff of adequate sample size, good selection criteria, and relevant control groups, etc, my two biggies are outcome measures (must be either objective or adequately blinded, or both), and measuring PEM.

We have decades of hard undeniable real world data about what happens when this standard is not upheld.

I'd ideally like to see ME/CFS advocacy groups signing up to some international agreement, where they undertake not to support research and researchers not meeting the guidelines.

We should openly refuse to be cannon fodder for shitty research, and explain clearly why. We are under no obligation to accept it nor submit to its 'results'.