Assessment of the scientific rigour of RCTs on the effectiveness of CBT and GET for ME/CFS: a systematic review (2019) Ahmed et al

Sometimes it's hard to find a way around the problem of subjective outcomes in unblinded studies. Because I assume it's not always possible to use objective outcomes. Suppose you have a psychological intervention that aims to change the mental wellbeing of patients, nothing more. That would be an outcome that is plausible but difficult to put into objective measures and thus to measure. I suppose science simply isn't capable of measuring these kinds of effects yet...
This is one reason mixed MUS studies will likely have few objective outcome measures that might theoretically be used in trials of ME/CFS alone. For example, actigraphy wouldn’t say much about whether an intervention has helped Irritable Bowel Syndrome.
 
Usually several papers on the one trial are normally seen as one trial rather than the way this paper presents them.
 
Cochrane reviews of CBT and (separately) GET for CFS involve tables like Figure 2 [“Summary of risk of bias of included studies”]. My guess is they don’t agree 100%.
 
I’m not sure of the classification of the PACE Trial recovery paper as “low risk of bias” for “Selective reporting (reporting bias)” given all four outcome measures were changed from the protocol and two of the thresholds were described as post hoc in the 2011 paper.
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They do say the following in the text, but many people may only look at the figure:
Deviations from its protocol are mentioned by O’Dowd et al. (2006) and White et al. (2011, 2013).
 
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I'm not happy with the classification of O'Dowd et al. 2006 as having a “low risk of bias” for “Selective reporting (reporting bias)” for the reasons discussed in this post:
https://www.s4me.info/threads/asses...view-2019-ahmed-et-al.9449/page-2#post-167344

They do say the following in the text, but many people may only look at the figure:
Deviations from its protocol are mentioned by O’Dowd et al. (2006) and White et al. (2011, 2013).
 
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What’s the Friedman study?
Sorry I meant Friedberg and the actimeter studies he did:
I might have overstated that he found an activity limit. If I remember correctly, the second study mostly showed that subjective improvements after CBT are not accompanied by objective improvements in actigraphy. And the first one is just a case study, but it does include the interesting passage:
this patient largely overcame his initially reported fear of triggering symptom exacerbations. Yet his concern about exceeding the maximum prescribed weight lifting levels appeared to be realistic because scheduled attempts to exceed these levels consistently triggered symptom flare-ups. In addition, the work-related 4-week relapse revealed an apparent upper limit on his ability to work. This suggests that eradication of a fear-based activity avoidance will facilitate functional improvements up to a point, beyond which a more biologically based mechanism of symptom generation may be involved
 
Table 1. Overview of interventions in the included studies.
Table 2. Outcome measures and measuring instruments used.
Table 3. ‘Improvement’ and ‘recovery’ operationalized as a combination of several outcome measures (cut-off scores).

Table 2 includes the following:
*Significant difference found compared to other/control group(s).
^Significant effect found compared to just one group (if more than one existed).
&Significant difference between baseline and final assessment within group.
#Increase over time from baseline to final assessment, significant difference between groups.
Subjective outcome measures in black; Objective measures are bold, italic and underlined.
These might be useful for people who want to get information quickly on studies, though ideally checked the original papers if one has time.
 
Very minor point:

In general, the interventions were found to be effective according the study results, as most studies (n = 15) found CBT and/or GET, either in the original form or an adapted therapy version, a positive treatment for ME/CFS patients. Three studies (Deale et al., 2001; Nunez et al., 2011; O’Dowd et al., 2006) did not consider CBT and/or GET directly suitable for treatment.
I have no idea what they are taking about with regards to the Deale et al. study.
Deale A, Husain K, Chalder T, et al. (2001) Longterm outcome of cognitive behaviour therapy versus relaxation therapy for chronic fatigue syndrome: A 5-year follow-up study. The American Journal of Psychiatry 158: 2038–2042.
 
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