Patient led measure of outcomes

[Kitty]

I am not saying that monitoring specific activities is not a useful tool, but which activities selected is highly significant as the act of selecting them will give them an increased importance.

That's a really important point, but (and I know I sound contrary!) I'm still not sure it matters. At least, not in the scenario I'm trying to work through.

The question I'm trying to anticipate is: does this treatment act on the underlying disease process in ME/CFS?

If it doesn't it should be reasonably obvious. Level 1 activities are there to show where the individual started pre-treatment, but they're not an outcome measure; the trial is looking for sustained progression to level 2 and 3 activities. That won't show up across the cohort if the treatment fails.

If it does work, the choices people have to make about minor daily living activities will fall away. Trying to juggle level 1 activities should become history, like trying to shower without getting the cast wet that time you broke your ankle.

The line of thought began after re-reading concerns about what happens if a trial shows a result so strong it seems likely the team's begun to unpick the lock. They have something that already exists and could potentially get people out of darkened rooms, but it needs replication on a bigger cohort.

I'm anticipating that trial. How do we set the outcomes so that a genuinely positive result is as convincing to sceptical doctors and grant panels as we can make it? Participants reporting how they feel might not be enough, even if backed up by other measures. Showing how their activity pattern changed—potentially drastically in some cases—might be.

 

[Hutan]

A slight caution on some of the measures. Having adopted a certain constrained lifestyle, we might be slow to bounce back to what might be regarded as 'normal'.

For example, I usually shower twice a week now. I'm not completely sure that if I miraculously became healthy again overnight, that I would change that a lot, at least in the winter and unless I started doing vigorous exercise. If I'm not sweating, I'm not sure that I would want to use the time and the cost of electricity to shower every day.

There are things like leaving the house too. If spouses and friends have dropped away and the social circle has shrunk, if you are out of the habit of going out for a drink, if you can't afford to go out for a meal, if you have online shopping down to a fine art, then there might be a lot fewer reasons to leave the house.

Certainly, something as basic and desirable as getting to the toilet would be a good measure for people currently unable to do that. But, for the majority of people likely to be participating in a study, that won't be an issue for them.

Getting a job might take a while when your CV has a decades-sized hole and you aren't yet completely confident that you can manage and not let people down. You might not have driven for years, you might have given away your sports equipment, you might not fit the clothes you had for your outdoor hobbies.

For many of us, especially those of us who have been ill for more than 10 years, we won't be the same person as we were when we were healthy. We will be older, have different priorities and interests, will perhaps be more cautious, less social and certainly a lot poorer. That might mean that identifying 3 or 5 sensitive measures of change might be difficult.

I think 'time spent lying down' and 'number of steps' would go a long way to measuring change in ME/CFS severity.