O'Dowd-Crawley early intervention study

Odd that there are only results after 6 months, not at the start of the trial, so no way of knowing whether there was overall improvement or not in both groups. Though I guess the important primary result is the uptake of the intervention was so low it's not feasible to run a bigger trial and the secondary outcome is no significant between group differences on any of the measures.

What a waste of money.
 
I have continued chasing up these data. They were going to publish and going to publish and going to publish. The contact was really helpful and thanked me for continuing to bring the matter to their attention.

It seems these data have finally been released and are available here.

I've had a quick look, and it seems to be the full anonymized set. If someone were able to look and confirm, I'd be grateful so I can reply to the FOI team there and say the matter is now closed.

@Lucibee @Adrian @Graham
 
JohnTheJack said:
As far as you can tell, does that look like the full anonymized data?
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At a glance, no. (tho pls check - I do miss things!). Looks like they haven't included the WPAI qs1-4, which includes no hours worked/not worked in past 7 days. They've only included qs 5 and 6. Here's a pdf of WPAI to see why that's important: http://oml.eular.org/sysModules/obxOml/docs/ID_98/WPAI-GH_English_US_V2.pdf
Summary data of WPAI were included in the basic results: http://www.isrctn.com/editorial/retrieveFile/283ff95f-3ce1-48dd-94d3-441b74834d04/23369
 
The data set is badly set out - a spreadsheet would be more helpful. I note their rationale for the 'early intervention' was to catch early people who might develop CFS/ME and do something to prevent it.

I've only looked at the SF-36 physical functioning and Chalder Fatigue questionnaire results for the untreated control group.

The thing that strikes me is that 6 months of doing nothing seems to be pretty effective at 'preventing CFS' since this particular group of patients showed little sign of it in the first place. Out of the 16 patients, only 7 were affected badly enough to be eligible for PACE at the start, and only one at the finish.

It's possible I'm misreading the data. It would be interesting to see an analysis including a between group comparison, if anyone can be bothered.
 
Lucibee said:
At a glance, no. (tho pls check - I do miss things!). Looks like they haven't included the WPAI qs1-4, which includes no hours worked/not worked in past 7 days. They've only included qs 5 and 6. Here's a pdf of WPAI to see why that's important: http://oml.eular.org/sysModules/obxOml/docs/ID_98/WPAI-GH_English_US_V2.pdf
Summary data of WPAI were included in the basic results: http://www.isrctn.com/editorial/retrieveFile/283ff95f-3ce1-48dd-94d3-441b74834d04/23369
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OK, thanks. They did say they'd get the complete set for me by the end of the month, but we'll see.
 
Lucibee said:
I don't understand. Why have they published the dataset but not a full report of the study?
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Because the feasibility study failed to achieve their objectives


3.2 Objectives
The specific objectives aim to inform the design of a full scale, adequately powered randomised trial. The feasibility trial objectives are:
1. To investigate the feasibility of assessing patients reporting persistent fatigue (1 -4 months) to their GP for eligibility into the RCT.
2. To evaluate the recruitment process including the information given, and whether randomisation is acceptable
3. To assess the utility and acceptability of health resource use questionnaires to assess the impact of care on health service use and productivity.
4. To use the information above to provide estimates of sample size required for a full scale study.
5. To investigate issues of retention in the RCT, including the acceptability of the care provided and reasons for any drop outs.
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The dropout rate for the intervention was 47%, but since most participants spontaneously recovered, and few would have met CFS criteria at any point (ignoring 6+ month requirement) it is impossible to say how large a full scale study would need to be. (it could be 1000+ participants required!)
 
Trish said:
The thing that strikes me is that 6 months of doing nothing seems to be pretty effective at 'preventing CFS' since this particular group of patients showed little sign of it in the first place. Out of the 16 patients, only 7 were affected badly enough to be eligible for PACE at the start, and only one at the finish.
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Thanks this seems like a useful observation, even if I think we already knew that a lot of people presenting with possible (broadly defined?) CFS to a GP are going to recover even before the six month mark.
 
JohnTheJack said:
It seems they couldn't get anyone to publish it. It would have been stuck in a drawer if I hadn't asked for the data.

As far as you can tell, does that look like the full anonymized data?
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Best guess would be that they didn't like the null results. There are no objective measurements, as usual. Frankly this is dereliction of duty from the funding institutions to never require any objective data after decades of the same research in a loop and 2 decades in practice. Seems like the only objective measures planned, hours worked and hours missed, were dropped. As is tradition.

Although looking at the data, I have no idea who these people are since there are 7 with a SF-36 baseline of 95+, who all ended up with 95+ at 6 months. Those have CFQ ranging from 15 to 28. Randomization was pretty bad, the control group had 5/16 of the 95+, leaving 2/20 for the EI group.

A quick calculation, removing missing entries, on SF-36, the only mildly relevant measure:
"Usual" care: start=67 end=84
"Usual" care + EI: start=60 end=77​

On absolute measure, the "intervention" yields a lower SF-36, but the same increase in report of 17. Some are dramatic changes, I see from 20 to 100 and from 10 to 70, but the direction of the various questionnaires have little relation to one another, they are all over the place. And there is a lot of missing data.

Roughly speaking, even by the usual abysmal standards of research by Crawley, this appears too bad to publish. I wonder how much copy and paste is involved in writing every paper, those trials all do the same thing anyway. Complete waste of public funds and academic resources.
 
Thanks a lot of John for his persistence on this (and also to those who first raised this issue long ago).

Lucibee said:
If it's in the ISRCTN registry, it should at least get picked up by subsequent Cochrane analyses, and NICE guideline committees, one would hope?
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I wonder if it would be worth a couple of people trying to do a short paper on the results (and maybe the trouble with getting the results out) to get it in the peer reviewed literature? Could also mention the spin around PACE and the difficulty of getting their prespecified results, and then ask Crawley/O'Dowd if they want their names attached?
 
Esther12 said:
I wonder if it would be worth a couple of people trying to do a short paper on the results (and maybe the trouble with getting the results out) to get it in the peer reviewed literature? Could also mention the spin around PACE and the difficulty of getting their prespecified results, and then ask Crawley/O'Dowd if they want their names attached?
Click to expand...

What would the paper say exactly? That there was a high dropout rate and most patients recovered spontaneously leading to insufficient sample size to attempt to detect a difference?
 
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