CBT combined with music therapy for chronic fatigue following Epstein-Barr virus infection in adolescents: a feasibility study, 2020, Wyller et al

Here’s the original version of the article: https://bmjpaedsopen.bmj.com/content/4/1/e000620.responses

Here’s my comment on that version of the article: https://bmjpaedsopen.bmj.com/content/4/1/e000620.responses

Here’s the retraction notice: https://bmjpaedsopen.bmj.com/content/4/1/e000620ret

Here’ the republished version: https://bmjpaedsopen.bmj.com/content/4/1/e000797


It would be good if we could make an overview of the most significant changes between the retracted and republished version. I don’t see many.
  • The title now says ‘a randomized controlled trial’ instead of ‘a feasibility study’. In other sentences the word ‘feasible’/’feasibility’ was replaced with ‘useful’/’usefulness’, we ‘explored’ was changed into we ‘studied’ etc.
  • In the abstract and conclusion the following has been added: “participants’ concern regarding school absence should be properly addressed to secure recruitment.”
  • Instead of highlighting trends the abstract now simply says that there were also no significant differences among the two groups. In the results and discussion section, however, the authors still highlight “most symptom scores tended to favour the intervention group” and “there was a trend towards higher recovery rate with a total of 8 (62 %) recovered individuals in the treatment group” and “we observed a concurrent tendency of improvement of many symptom scores, including fatigue and postexertional malaise, in the intervention group.”
  • While the original conclusion read: “The tendencies towards positive effects on patients’ symptoms and recovery might justify a full-scale clinical trial”, the rewritten conclusion reads: “A fully powered trial is needed to evaluate efficacy”. So without highlighting tendencies towards positive effects.
  • The abstract makes clear that there was a low response rate: “A total of 91 individuals with postinfectious CF were eligible, and a total of 43 were included (21 intervention group, 22 control group).” In the original version they simply said: “A total of 43 individuals… without mention that 91 patients were eligible.
Did anyone find other significant changes?
 
Robert 1973 said:
thanks to Michiel, @dave30th and others for their work on this.
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Yes, another example of how important your work is, @Michiel Tack and @dave30th .Thank you to everyone involved.

rvallee said:
I'm a bit puzzled by the apparent strategy of not blaming the authors, which would mean the editorial process broke in multiple ways and would require changes or reforms in response so that this does not happen again. Especially because there is a habit of it, with Crawley's multiple violations as one example.
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Robert 1973 said:
I don’t understand how the editors could have read Michiel’s comments and agreed to publish this revised version of the paper in good faith.
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Yes. As far as I can see tha editors don't disclose what their error actually was. In my view, the journal's error was to not reject the paper.

[Edit: ] It would be a precedent if they did admit that.

Instead, they let the authors republish the paper with an amended title.

So it seems in protecting the authors they try to protect themselves, too.


Haven't read the republished paper yet but in addition to the points highlighted by Midnattsol and Michiel I saw that it still refers to the old version of the Cochrane review when it states:

"graded exercise therapy (GET) in itself is shown to have beneficial effects in CFS."

And of course, the abstract's first sentence still is:

"Cognitive–behavioural therapy (CBT) is effective in chronic fatigue (CF) syndrome."(*)

Actually, it's slightly amended: It now even more clearly implies the authors' understanding of CFS of just being a syndrome of "CF".

Previous version: "Cognitive–behavioural therapy (CBT) is effective in chronic fatigue syndrome."

dave30th said:
haven't read it yet. More letters to BMJ are likely forthcoming. it's pretty disgraceful.
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I hope that also Retraction Watch will follow up the editors' understanding of transparency and research integrity.

They quote one of the editors:

"I want to make it clear that the authors were not responsible for this error. Chronic fatigue syndrome is still not fully understood and dogged by controversy, so it’s important to add to the knowledge base, hence the decision to invite the authors to resubmit their original study."

So the editors' understanding of adding to the knowledge-base is to publish a still highly miselading paper that references other highly misleading work in a misleading way that equally wasn't retracted because editors preferred to protect the authors instead of research integrity.

In addition to the misleading reference to the Cochrane review hey also approvingly refrerence the lightning process study when they claim that:

"Preliminary evidence suggests that a multidisciplinary approach combining CBT with other elements might improve effectiveness as compared with CBT alone in patients suffering from CFS".

(Edited for clarity.)

(*) Edited to add: In the full text, the authors write:
"Evidence suggests a beneficial effect of cognitive–behavioural therapy (CBT) in adults5 and adolescents6 with chronic fatigue syndrome (CFS), as well as in CF from well-defined causes such as cancer7 and diabetes.8"

The references for CFS are the PACE trial and FITNET; the papers referenced for CF in cancer and diabetes are both co-authored by Hans Knoop.
 
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MSEsperanza said:
Yes, another example of how important your work is, @Michiel Tack and @dave30th .Thank you to everyone involved.





Yes. As far as I see tha editors don't disclose what their error actually was. In my view, the journal's error was to not reject the paper. They can't admit that and at the same time let the authors republish the paper with an amended title.

So it seems in protecting the authors they try to protect themselves, too.

Haven't read the republished paper yet but saw that it still refers to the old version to the Cochrane review when it states:

"graded exercise therapy (GET) in itself is shown to have beneficial effects in CFS."

And of course, ithe first sentence still is:

"Cognitive–behavioural therapy (CBT) is effective in chronic fatigue (CF) syndrome."

Actually, it's slightly amended: It now even more clearly implies the author's understanding of CFS of just being a syndrome of "CF".

Previous version: "Cognitive–behavioural therapy (CBT) is effective in chronic fatigue syndrome."


I hope that Retraction Watch will also follow up the editors' understanding of transparency and research integrity.

They quote one of the editors:

"I want to make it clear that the authors were not responsible for this error. Chronic fatigue syndrome is still not fully understood and dogged by controversy, so it’s important to add to the knowledge base, hence the decision to invite the authors to resubmit their original study."

...and publish a still highly miselading paper that references other highly misleading work in a misleading way that equally wasn't retracted because editors preferred to protect the authors instead of research integrity.

In addition to misleading references to the Cochrane review hey also refrerence the lightning process study when they claim that:

"Preliminary evidence suggests that a multidisciplinary approach combining CBT with other elements might improve effectiveness as compared with CBT alone in patients suffering from CFS".
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The use of CF and CFS in this text is indeed a muddle (also in the application). And the use of references is not in line with research integrity.
 
chrisb said:
I have not previously seen that

chronic fatigue (CF) syndrome

That means that subsequent use of "CF" refers to "chronic fatigue" and not "chronic fatigue syndrome". Th paper seems very vague on this point
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It does. And the conclusion that subsequent research should be done on patients with CFS comes out of the blue when they've focused so much on CF beforehand.
That said, the increased recovery rate after 15 months in the intervention group might indicate that mental training for postinfectious CF is clinically useful. This can only be determined in a full-scale clinical trial. Such a trial should be sufficiently powered to determine effects in the subgroup of CF individuals that adhere to diagnostic criteria of CFS. The low number of participants in the present study precluded us from performing such subgroup analyses.
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Jonathan Edwards said:
I agree. I see little point in being English and sticking to niceties when people are walking all over the rules.
I am in medical research and would once not have used the word lie but times have changed dramatically. People are lying here and maybe more than one lot.
They are also doing it rather badly.
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I remember talking to the late great Doug Altman in May 2018. I had been pestering him and colleagues on and off to look at PACE, and the Crawley research, and he knew I was really worked up about it, but he didn't have time (or I think inclination) to get involved. But on that occasion over lunch at a conference/meeting, he told me that he was considering strengthening his vocabulary when writing about the problems in research to include "lying". I realised this was a big thing for him to say, and I sensed he was quite upset. For despite calling out the travesties, particularly regarding the misuse and poor reporting of statistics in research, he would never name and shame - he never had a bad word to say about anyone.
 
In the first version submitted, the authors didn’t use the term “feasibility study” but “exploratory randomized trial” in the title and they stated their conclusion more firmly as:

“A mental training program combining music therapy and cognitive behavior therapy lowered the level of physical activity, improved symptoms of post-exertional malaise, led to higher recovery rate over time, did not cause harm, and appeared feasible in adolescents suffering from chronic fatigue after Epstein-Barr virus infection.”
https://bmjpaedsopen.bmj.com/content/bmjpo/4/1/e000620.draft-revisions.pdf
​
That was, of course, all inappropriate because the small sample size doesn’t allow to make such conclusions.

The strange thing about this study is that the number of participants the authors tried to recruit (50) is much lower than the number the power analysis suggested was needed to detect a difference of moderate effect size (120). So it was powered only to detect large effect sizes. The authors justified this by saying that since "CBT alone is documented to have a moderate effect size in CFS/ME, only a substantial effect size is of direct clinical interest. Analogously, only a substantial treatment effect is of interest regarding markers of pathophysiology.” In the protocol, they also argue that “the FITNET study suggests that larger treatment effects might be assumed in adolescent CFS/ME patients as compared to adults.”

So when they presented their results, this reasoning was ignored, and instead, good acceptability and feasibility of the intervention were emphasized. That the trends towards improvement were not statistically significant was disregarded because this was only a very small trial and the positive trends were said to argue for a fully powered randomized trial.

This was quite confusing. One reviewer, Maria Loades, made the following remark about this:

“I struggle to understand from the aims of the study and the way the study is described whether this was intended as a feasibility study – i.e. to look at feasibility (can this be done?), acceptability (how do participants experience it?) and to give some indication of potential effect sizes to power a future larger scale trial, or whether this was intended as a fully powered trial. Throughout, I think this needs to be clarified for the reader and interpretations/conclusions drawn in light of what the aim was.”​

To which the authors responded:

“Thank you. We agree – this study should be regarded a feasibility study, and the manuscript has been rephrased accordingly.”
​
It could be that editors suggested this as well: that given the very low sample size and power, this study looks more like a feasibility study and that it should be presented as such. Even if this is true and there was such a suggestion by the editors, the authors still rephrased and published the study as a feasibility study, knowing that this wasn’t how it was designed or presented in their protocol and statistical analysis plan. So the statements by editor Imti Choonara and the BMJ retraction notice that “the authors were not responsible for this error” or that “this was not due to error on behalf of the authors” are very likely untrue.

The main issue with rephrasing the study as a feasibility study is that the authors could escape the conclusion that the intervention wasn’t as effective as they thought. If the intervention did show significant improvements (as can happen by chance) the authors would have probably touted it as an important finding. If the intervention didn’t show the improvements hoped for (as was the case) then they could highlight acceptability and feasibility and say that trends toward improvement deserve further study (as they did). So either the intervention is highly effective or it needs further study. This methodology should be avoided as it increases the chance of false findings and the risk that scarce funds are diverted to research ideas that do not merit those investments.

The fact that the authors have rephrased their paper and avoided the use of the word ‘feasibility’, changes little to all of this. They are still avoiding the main conclusion that can be drawn from this study, namely that the intervention failed to show improvements of a large effect size compared to the control group.
 
Some of the issues raised such as the addition of post-exertional malaise as an outcome when it wasn't listed as one of the secondary outcomes or the highlighting of recovery rates even though these do not take dropouts into account, and the difference only appear after the treatment.

I think the paper is still misleading.

In addition, the republished version does not make clear at all that there were issues with this paper that justified a retraction (and my comment is no longer there, so the issues that weren't addressed have now become free of criticism).
 
Michiel Tack said:
Here’s the original version of the article: https://bmjpaedsopen.bmj.com/content/4/1/e000620.responses

Here’s my comment on that version of the article: https://bmjpaedsopen.bmj.com/content/4/1/e000620.responses

Here’s the retraction notice: https://bmjpaedsopen.bmj.com/content/4/1/e000620ret

Here’ the republished version: https://bmjpaedsopen.bmj.com/content/4/1/e000797


It would be good if we could make an overview of the most significant changes between the retracted and republished version. I don’t see many.
  • The title now says ‘a randomized controlled trial’ instead of ‘a feasibility study’. In other sentences the word ‘feasible’/’feasibility’ was replaced with ‘useful’/’usefulness’, we ‘explored’ was changed into we ‘studied’ etc.
  • In the abstract and conclusion the following has been added: “participants’ concern regarding school absence should be properly addressed to secure recruitment.”
  • Instead of highlighting trends the abstract now simply says that there were also no significant differences among the two groups. In the results and discussion section, however, the authors still highlight “most symptom scores tended to favour the intervention group” and “there was a trend towards higher recovery rate with a total of 8 (62 %) recovered individuals in the treatment group” and “we observed a concurrent tendency of improvement of many symptom scores, including fatigue and postexertional malaise, in the intervention group.”
  • While the original conclusion read: “The tendencies towards positive effects on patients’ symptoms and recovery might justify a full-scale clinical trial”, the rewritten conclusion reads: “A fully powered trial is needed to evaluate efficacy”. So without highlighting tendencies towards positive effects.
  • The abstract makes clear that there was a low response rate: “A total of 91 individuals with postinfectious CF were eligible, and a total of 43 were included (21 intervention group, 22 control group).” In the original version they simply said: “A total of 43 individuals… without mention that 91 patients were eligible.
Did anyone find other significant changes?
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Did they submit a CONSORT checklist with their manuscript?? Is there a flow diagram? https://www.equator-network.org/reporting-guidelines/consort/
I will have a look when I get the chance...
 
Michiel Tack said:
Some of the issues raised such as the addition of post-exertional malaise as an outcome when it wasn't listed as one of the secondary outcomes or the highlighting of recovery rates even though these do not take dropouts into account, and the difference only appear after the treatment.

I think the paper is still misleading.

In addition, the republished version does not make clear at all that there were issues with this paper that justified a retraction (and my comment is no longer there, so the issues that weren't addressed have now become free of criticism).
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It is simply unbelievable (except of course it happens all the time) that the trial registration (https://clinicaltrials.gov/ct2/show/NCT02499302) doesn't mention PEM yet they still report it in the paper. "Interestingly, we observed a concurrent tendency of improvement of many symptom scores, including fatigue and postexertional malaise, in the intervention group"

Also, where are the reviewers reports??
 
Caroline Struthers said:
It is simply unbelievable (except of course it happens all the time) that the trial registration (https://clinicaltrials.gov/ct2/show/NCT02499302) doesn't mention PEM yet they still report it in the paper. "Interestingly, we observed a concurrent tendency of improvement of many symptom scores, including fatigue and postexertional malaise, in the intervention group"

Also, where are the reviewers reports??
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And the trial registration clearly states participants would meet CFS criteria.
 
Michiel Tack said:
Did anyone find other significant changes?
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https://www.diffchecker.com/

edit: I've somehow messed this post up while writing it... give me a few minutes to sort it out!

Lots of changes of 'feasibility' to 'usefulness'.

eg:

The aim of the present study was to explore the feasibility of this mental training programme in adolescents suffering from CF after acute EBV infection, and to provide preliminary estimates of effects as a basis for a full-scale clinical trial in the future.
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to

The aim of the present study was to explore the usefulness of this mental training programme in adolescents suffering from CF after acute EBV infection.
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Looking through these changes makes the claim that this was just a problem caused by the journal's editorial mishap, rather than a problem with the authors, really odd.

As this was a feasibility study, a formal power calculation was not considered necessary. It should be noted, though, that in a previous research project from our institution, CFS adolescents had a mean (SD) steps/day count of approximately 4500 (2400), and a mean (SD) CFQ total score of 19.1 (6.3).34 This given, more than 120 participants would be needed in order to detect a moderate effect size (Cohen’s d≈0.5), such as an increase in steps/day of 1200 or a reduction in CFQ total score of 3 (α=0.05, β=0.2). In the present study, the total number of eligible individuals was 91 (defined as CF cases 6 months after acute EBV infection), and only 43 consented to inclusion. Hence, the study was strongly underpowered regarding efficacy.

The ‘full analysis set’ (all randomised participants) was used for intention-to-treat analyses of efficacy. Missing values were imputed using the principle of last observation carried forward. In addition, a non-imputed data set was used for per-protocol analyses. Continuous variables were reported as means or medians, as appropriate. Categorical variables were reported as numbers and percentages. General linear models (analysis of covariance) were used for analyses of treatment effect; the baseline values of each efficacy endpoint were included as covariates. Safety data were summarised descriptively through appropriate data tabulations and descriptive statistics.
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to

In a previous research project from our institution, CFS adolescents had a mean (SD) steps/day count of approximately 4500 (2400), and a mean (SD) CFQ total score of 19.1 (6.3).34 This given, more than 120 participants would be needed in order to detect a moderate effect size (Cohen’s d≈0.5), such as an increase in steps/day of 1200 or a reduction in CFQ total score of 3 (α=0.05, β=0.2). In the present study, the total number of eligible individuals were 91 (defined as CF cases 6 months after acute EBV infection), and only 43 consented to inclusion. Hence, the study was strongly underpowered regarding efficacy.

All statistical analyses were carried out using SPSS statistical software (IBM SPSS Statistic 26). The ‘full analysis set’ (all randomised participants) was used for intention-to-treat analyses of efficacy (see online supplemental file 2). A total of 55% of the included cases had missing data points. A convenient ‘rule of thumb’ suggests that the number of imputations should be similar to the percentage of cases that are incomplete.35 Thus, multiple imputation with 55 iterations was performed using the procedure implemented in SPSS. For normally distributed variables with definite minimum and maximum, constraints were defined. In addition, a non-imputed dataset was used for per-protocol analyses. Continuous variables were reported as means or medians, as appropriate. Categorical variables were reported as numbers and percentages. General linear models (ANCOVA, analysis of covariance) were used for analyses of treatment effect; the baseline values of each efficacy endpoint were included as covariates. Safety data were summarised descriptively through appropriate data tabulations and descriptive statistics.

Supplemental material

[bmjpo-2020-000797supp002.pdf]
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Protocol deviations

There was a trend towards lower number of steps/day as well as an improvement of postexertional malaise in the intervention group at 3 months (table 3, figure 3). The development of most other symptom scores tended to favour the intervention group; however, effects were small.
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to

Protocol deviations

In intention-to-treat analyses, the primary endpoint (number of steps/day) did not differ significantly between the intervention group and the control group (table 3, figure 3). Also, secondary outcome measures were not significantly different among the two groups. However, most symptom scores tended to favour the intervention group whereas physical activity tended to be higher in the control group.
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There are significant differences and similarities in the discussion section:

Discussion

This study shows that a mental training programme combining music therapy and CBT for postinfectious CF is feasible. Also, the study indicates that the mental training programme may improve symptoms and lead to higher recovery rate over time; however, a full-scale clinical trial with sufficient statistical power would be necessary to demonstrate such an effect.

The acceptance of the intervention among the participants is a main determinant of feasibility. In the present study, the compliance with appointments among those who completed the intervention was high, and the incidence of self-reported adverse events was very low and almost identical among the intervention group and the control group. Taken together, this suggests that the intervention was well tolerated, corroborating results from a recently published qualitative study which reported high levels of satisfaction among those who received the mental training programme.35 We cannot rule out that the dropout of six individuals in the intervention group before or immediately after start-up of therapy was due to low tolerability in these participants. However, more probably, this loss to follow-up had the same cause as the poor recruitment of eligible patients into the study. The most likely explanation for these two phenomena is the introduction of a nationwide high school sick leave precept during the study period. This precept initiated public controversies, and—in the context of the present study—caused a lot of concern among the eligible adolescents about participating in a mental training programme that would inevitably result in some school absence. This underlines the importance of considering similar contextual hindrances in the event of a future full-scale clinical trial. Furthermore, given this explanation, we assume the risk of strong selection bias to be rather low, as is supported from the lack of differences between the included and the non-included groups for background and efficacy variables.

Most CBT treatment protocols for CF and CFS encompass an element of increased physical activity over time,5 6 and graded exercise therapy (GET) in itself is shown to have beneficial effects in CFS.36 37 Our mental training programme did not contain this element, which may explain why physical activity to our surprise actually tended to decline in the intervention group during the treatment period. Interestingly, we observed a concurrent tendency of improvement of postexertional malaise in the intervention group. This is in line with the own experiences of patients with CFS, often reporting an initial worsening of symptoms during physical exercise which in turn might contribute to the strong controversy over studies that recommend GET in patients with CFS.38 39 Thus, the therapeutic approach applied in the present study might be more acceptable from a patient perspective, which further adds to its feasibility.

It has been demonstrated that postinfectious CF tends to recover spontaneously1; thus, only a small minority of patients develop CFS over time. Accordingly, in the present study, we observed symptom improvement over time in both the intervention group and the control group. Thus, a modest beneficial effect of the mental training programme might have been somewhat ‘diluted’ by the natural course of the postinfectious CF phenomenon. That said, the increased recovery rate after 15 months in the intervention group might indicate that mental training for postinfectious CF is clinically useful. This can only be determined in a full-scale clinical trial. Such a trial should be sufficiently powered to determine the effects in the subgroup of CF individuals who adhere to diagnostic criteria of CFS. The low number of participants in the present study precluded us from performing such subgroup analyses.

Strengths and limitations

The strengths of this study are the relatively homogeneous group of adolescent participants with the same infectious precipitation of CF and with no known comorbidities. Weaknesses encompass the lack of formal fidelity checking among the therapists, and the lack of data regarding compliance with recommended homework in-between appointments.

Conclusion

An intervention study of combined CBT and music therapy in postinfectious CF is feasible, and appears acceptable for the participants. The tendencies towards positive effects on patients’ symptoms and recovery might justify a full-scale clinical trial.
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to

Discussion

This study shows that a mental training programme combining music therapy and CBT for postinfectious CF is feasible. However, the study was strongly underpowered and should be considered exploratory; a full-scale clinical trial with sufficient statistical power would be necessary to evaluate efficacy. In further research, participants’ concern regarding school absence due to therapy sessions should be properly addressed to secure recruitment.

Most CBT treatment protocols for CF and CFS encompass an element of increased physical activity over time,5 6 and graded exercise therapy (GET) in itself is shown to have beneficial effects in CFS.36 37 Our mental training programme did not contain this element, which may explain why physical activity to our surprise actually tended to decline in the intervention group during the treatment period. Interestingly, we observed a concurrent tendency of improvement of many symptom scores, including fatigue and postexertional malaise, in the intervention group. This is in line with own experiences of patients with CSF, often reporting an initial worsening of symptoms during physical exercise which in turn might contribute to the strong controversy over studies that recommend GET in patients with CSF.38 39 Thus, the therapeutic approach applied in the present study might be more acceptable from a patient perspective.

It has been demonstrated that postinfectious CF tends to recover spontaneously1; thus, only a small minority of patients develop CFS over time. Accordingly, in the present study, we observed symptom improvement over time in both the intervention group and the control group. Thus, a modest beneficial effect of the mental training programme might have been somewhat ‘diluted’ by the natural course of the postinfectious CF phenomenon. That said, the increased recovery rate after 15 months in the intervention group might indicate that mental training for postinfectious CF is clinically useful. This can only be determined in a full-scale clinical trial. Such a trial should be sufficiently powered to determine effects in the subgroup of CF individuals that adhere to diagnostic criteria of CFS. The low number of participants in the present study precluded us from performing such subgroup analyses.

In the present study, the compliance with appointments among those who completed the intervention was high, and the incidence of self-reported adverse events was very low and almost identical among the intervention group and the control group. Taken together, this suggests that the intervention was well tolerated, corroborating results from a recently published qualitative study which reported high levels of satisfaction among those that received the mental training programme.40 We cannot rule out that the drop-out of six individuals in the intervention group before or immediately after startup of therapy was due to low tolerability in these participants. However, more probably, this loss to follow-up had the same cause as the poor recruitment of eligible patients into the study. The most likely explanation for these two phenomena is the introduction of a nationwide high-school sick leave precept during the study period. This precept initiated public controversies, and—in the context of the present study—caused a lot of concern among the eligible adolescents about participating in a mental training programme that would inevitably result in some school absence. This underlines the importance of considering similar contextual hindrances in the event of a future full-scale clinical trial. Furthermore, given this explanation, we assume the risk of strong selection bias to be rather low, as is supported from the lack of differences between the included and the non-included group for background and efficacy variables.

Strengths and limitations

Strengths of this study are the relatively homogeneous group of adolescent participants with the same infectious precipitation of CF and with no known comorbidities. Weaknesses encompass the poor recruitment leaving the study strongly underpowered, lack of formal fidelity checking among the therapists, and the lack of data regarding compliance with recommended homework in-between appointments.

Conclusion

An intervention study of combined CBT and music therapy in postinfectious CF is feasible. A fully powered trial is needed to evaluate efficacy. Participants’ concern regarding school absence should be properly addressed to secure recruitment.
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There were other small changes too.
 
Should we be sympathetic to the journal for the seeming white-wash on the authors?

Does anyone know what sort of legal pressure journals can come under?

Or is this more likely to be BMJ BS of caring more about protecting bad researchers from the mob of unruly ME patients who refuse to be grateful to Wyller & co for all they've done for us?
 
Methods Adolescents (12–20 years old) participating in a postinfectious cohort study who developed CF 6 months after an acute EBV infection were eligible for the present study

Does this make sense to anyone? Why would participants have developed CF six months after infection? Are there established criteria for CF which specify this period. Are they not merely confusing this with criteria for CFS, which is ,of course not what they purport to be studying? Not at all. One would presume that they merely continued to suffer fatigue after infection. Where are the criteria for CF which specify the six months delay?
 
There are still so many severe flaws in the paper and in the first open and the 2nd, not (yet) "opened" review process, that I find it difficult to track which of them are the most relevant and also which of them have been already addressed by whom.

So apologies if my comments are redundant, but...

dave30th said:
I have no idea what an "exploratory randomized trial." I assume they used to the term to indicate that it was a trial but that it was "exploratory" so they could then apply for more money since they didn't have enough participants to make it "fully powered."
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Does anyone know whether ""exploratory randomized trial" is an established term in trial methodology?

(see also my previous post here.)
 
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Esther12 said:
Or is this more likely to be BMJ BS of caring more about protecting bad researchers from the mob of unruly ME patients who refuse to be grateful to Wyller & co for all they've done for us?
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I read this as the editor, probably with input from editorial board (which includes Esther Crawley), seeing this as a convenient face-saving way of not upsetting any of their contributors. An editorial mistake is just a slight oversight. It does not put any pressure on any authors or on any referees who might have provided muddled opinions - or indeed suggested an idea to the authors that on reflection wasn't so hot.
 
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