Protocol ReCOVer: A RCT testing the efficacy of CBT for preventing chronic post-infectious fatigue among patients diagnosed with COVID-19.

[Keela Too]

Any recorded activity or new intervention, not normally done by the patient adds bias, people are motivated to do this activity to fill it in for a person they perceive to be in authority eg. therapist, to be a good study participant.

Similarly with wearing an actigraph (embedded in an iWatch and presumably a Fitbit). When you have to actively put this on, after showering, wear it an bed etc it is a conscious action

Ah yes, agree. I read your statement as suggesting trackers added additional bias to simple subjective records.

However, I think that a longer period of using a tracker would mean that any increase, caused by some optimistic bias on the part of the patient, would be unsustainable over say a 3 month period. I suspect it might be sustainable over 6 weeks or so. (I base that on my early cycles of crashing after six weeks of apparent “improvement”.)

Further, the magnitude of the improvement could be better measured. Subjective measures are easily skewed by interpretations advantageous to those wanting to prove their pet therapy. Trackers would better demonstrate the degree of improvement.

 

[Sean]

Edit to add: I’m aware that a patient might alter their behaviour “knowing” they are wearing a measuring device,

Over time it is possible to forget you are wearing a device,

However, I think that a longer period of using a tracker would mean that any increase, caused by some optimistic bias on the part of the patient, would be unsustainable over say a 3 month period. I suspect it might be sustainable over 6 weeks or so.

Yes. Actigraphy needs to be long term, so this potential bias washes out.

Further, the magnitude of the improvement could be better measured. Subjective measures are easily skewed by interpretations advantageous to those wanting to prove their pet therapy. Trackers would better demonstrate the degree of improvement.

This.

You can tell how much of a threat to the BPS business model objective measures are by how ferociously the BPSers oppose them, and how ludicrous are their stated reasons.

 

[alex3619]

However, I think that a longer period of using a tracker would mean that any increase, caused by some optimistic bias on the part of the patient, would be unsustainable over say a 3 month period.

This is why long term follow up studies need to look for regression to the mean. Like they found in the PACE trial.

 

[alex3619]

You can tell how much of a threat to the BPS business model objective measures are by how ferociously the BPSers oppose them, and how ludicrous are their stated reasons.

Yep, medical politics and the defense of the indefensible.

 

[Trish]

Any recorded activity or new intervention, not normally done by the patient adds bias, people are motivated to do this activity to fill it in for a person they perceive to be in authority eg. therapist, to be a good study participant.

Similarly with wearing an actigraph (embedded in an iWatch and presumably a Fitbit). When you have to actively put this on, after showering, wear it an bed etc it is a conscious action.

I personally don’t use tech or diaries, I work out how I am feeling by listening to my body and making my own judgement on my physical state of health and what measures I should be doing to improve things based on past experience.

I think you make a good point about any recording by a patient taking part in a study that asks them to behave differently, such as keeping an activity or diet diary, or wearing an actimeter, will to some extent change their behaviour. So if someone would find it an imposition to wear a device and have to remember to take it off for showering and for recharging its battery does have an impact. Similarly having to write down daily or even hourly activity on paper or an app is an imposition, and uses energy. For me keeping an activity diary was a far more intrusive imposition than wearing a fitbit.

I certainly changed my behaviour when I started wearing a fitbit insead of a watch, but not because of the fact I was wearing it, since I was accustomed to a watch on the same wrist, but because looking at the step counts and heart rates helped me to pace better and crash less often. But I think the point is, if I were part of an ongoing study, that wouldn't matter at all, since the whole point is to get an accurate reflection of what I actually do and am able to sustain doing over months or years.

I would assume that anyone who didn't feel able to cope with wearing an actometer over a period of months, and probably filling in some sort of symptoms scoring on an app each day as well, would simply choose not to participate in a study that requires these.

Edit to add: I think if a study includes treatment, and if actimeters are being used as an outcome measure, then it would be important to get the participants to wear the actimeter and record symptoms for at least a few months before they start the treatment, both to acclimatise them to the recording process, and to get a fair measure of their initial activity level and symptoms, and the degree to which these fluctuate without treatment.

 

[Sean]

Pretty sure most current actigraphs are waterproof and don't need to be removed for having a shower, going for a swim, etc. The less attention that needs to be paid to them by the wearer, the better.

At most they should only need to be removed once a week for charging.

Also would like to see both wrist and ankle versions being used, at least for the first round of such studies, to see if it adds anything useful.

I certainly changed my behaviour when I started wearing a fitbit insead of a watch, but not because of the fact I was wearing it, since I was accustomed to a watch on the same wrist, but because looking at the step counts and heart rates helped me to pace better and crash less often.

It would be interesting to compare one group who get real time feedback from their actigraph on some measures such as heart rate and step count, with another group using the same actigraphs except without any real time feedback to the wearer (apart from indicating that the actigraph is charged and turned on).

 

[adambeyoncelowe]

You could always give patients step counters without a screen. So they can't see their own steps. That would give a less biased sample, if that's your worry?

 

[chrisb]

On the question of keeping a diary of activity. I am sure that I have seen something from the early days, and I was quite surprised by it, that the purpose is not the information which it provides as to activity. It is the act of keeping the diary which alters behaviour and forms part of the therapy.

 

[Wonko]

I find such things 'extremely disruptive'.

Every erg of 'spare' capacity goes into them, as well as some core capacity (i.e diaries/logs etc. impact my ability to do the basics, by which I don't just mean things like hoovering/cleaning, acquiring food, or even washing (myself), I mean food/drinks, the consumption of.)

Everything becomes about the diary/log, virtually every minute - as these things normally involve acting/recording at set times I have to be aware, all of the time - or it doesn't happen.

This leaves me with insufficient cognitive capacity to do, or even notice, other things.

So, yeah, they do 'alter behaviour', and not in a good way.

 

[dave30th]

At the same time, asking participants to wear actometers for at least six months (you need at least two time points) is much more of a burden. I wonder if they'll look at whether activity stayed constant over the 12 days, or changed over that time.

i can't tell if the actimeter data are considered actual outcomes. Where do you see that this will not be measured at the very end?

 

[Esther12]

i can't tell if the actimeter data are considered actual outcomes. Where do you see that this will not be measured at the very end?

They listed it under 'Other study outcomes':

Activity: An actigraph is used to assess the participant’s level of physical activity. The actigraph is worn around the wrist for 14 consecutive days and nights for a reliable estimate of daily activity for 12 full days. The actigraph has been shown to be a reliable and valid instrument for the assessment of physical activity [53, 67].

They say: "At T0 and T1, data on physical activity level and sleep are also gathered by using an actigraph and completing a sleep diary."

They also had this table on outcomes and when they are to be measured:

https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05569-y/tables/3

 

[dave30th]

They also had this table on outcomes and when they are to be measured:

Ah, thanks!

 

[Barry]

Do actigraphs accrue a time-based data log that can subsequently be analysed / graphed, as their name suggests?

 

[dave30th]

I wonder if they'll look at whether activity stayed constant over the 12 days, or changed over that time.

Interesting. I think other studies generally average over the seven days (I think it's usually that, not 14 days, in these studies) and do not break down the changes across the time period. Or maybe they do?

 

[Snow Leopard]

Do actigraphs accrue a time-based data log that can subsequently be analysed / graphed, as their name suggests?

That is the goal, yes.

 

[Andy]

Trial By Error: Dutch CBT Trial Targets “Dysfunctional Beliefs About Fatigue” in Long Covid Patients

"So the intervention addresses all the mechanisms through which patients, per the investigators, are bringing this fatigue on themselves. Neat! However, it is important to note that the protocol presents no evidence that the fatigue experienced by Covid-19 patients has anything to do with “dysfunctional beliefs about fatigue,” “perceived low social support,” “fears and worries regarding COVID-19,” or the other itemized factors. These speculations are apparently based on the beliefs of the researchers. Since they favorably cite results from the discredited PACE trial as part of the evidence base, their judgement can be questioned."

https://www.virology.ws/2022/01/07/...beliefs-about-fatigue-in-long-covid-patients/

 

[ME/CFS Skeptic]

It's rather misleading that the title states this is a controlled randomised trial.

Patients in the control group receive no intervention from the researchers but only the standard medical care they manage to gather themselves from their treating physicians, GP or other therapists. So the care, attention and contact time of CBT therapists isn't controlled for at all and could explain any improvements the trial might show, given that all listed primary and secondary outcomes measures are subjective measurements (actigraphy is mentioned but it is not clear if it will be used as an outcome measures or a mediation variable)

As @Arvo clarified, the website describes Fit after COVID (CBT) as the intervention while the other group is explicitly described as the control group. The website claims that they already know CBT is effective for fatigue, that they hope it will also work for patients with long COVID. Patients in the control group will receive the intervention after the trial ends.

Clearly this is a very biased way of setting up a trial and it is not "controlled" in the way this term is normally used. It is unclear how the trial could give us meaningful results.

 

[ME/CFS Skeptic]

Apparently, one has to pay €1065 to submit a letter to the journal to point out some of the problems with this trial.
https://trialsjournal.biomedcentral.com/about

 

[dave30th]

Clearly this is a very biased way of setting up a trial and it is not "controlled" in the way this term is normally used. It is unclear how the trial could give us meaningful results.

Exactly. it can't.

 

[dave30th]

(actigraphy is mentioned but it is not clear if it will be used as an outcome measures or a mediation variable)

Right. it's listed as an outcome but doesn't seem to be one of the formal outcome measurements, especially because they are using it only at end-of-treatment, not at the follow-up point.