Briefing on the Institute of Medicine report in Washington, D.C. --webcast March 25

[Ember]

SEID is not a research definition. Its a clinical definition. As a result it would have to be modified/operationalized for SEID to be used in research. That will take time. Several years potentially.

Stand by... The P2P draft report recommends to NIH “that the ME/CFS community agree on a single case definition (even if it is not perfect).” We're now awaiting the final report!

 

[alex3619]

Stand by... The P2P draft report recommends to NIH “that the ME/CFS community agree on a single case definition (even if it is not perfect).” We're now awaiting the final report!

I don't have any faith in the P2P process either.

PS However despite that the IOM and P2P processes were supposed to be cooperating, they failed to do so. In a very big way they are disconnected from each other. Just another example of poor overall management.

 

[Ember]

In a very big way they are disconnected from each other. Just another example of poor overall management.

We shall see.

 

[caledonia]

PS However despite that the IOM and P2P processes were supposed to be cooperating, they failed to do so. In a very big way they are disconnected from each other. Just another example of poor overall management.

The P2P final report was being worked on after the IOM report was available, so it's possible that parts were changed to rectify it with the IOM report. We'll know in about two weeks.

 

[alex3619]

The P2P final report was being worked on after the IOM report was available, so it's possible that parts were changed to rectify it with the IOM report. We'll know in about two weeks.

Yes, but if this happens it will be blatantly obvious. It would be tampering.

 

[Denise]

In theory the P2P report might be amended based on comments submitted.
Being able to compare what was submitted to what ends up in the final report is just one of the reasons it is so important that NIH retain submitted comments. (And I am very glad we were able to get them to do so.)
Being able to compare the final P2P report to the submitted comments and to the IOM report as well might be quite interesting....

 

[caledonia]

SEID is not a research definition. Its a clinical definition. As a result it would have to be modified/operationalized for SEID to be used in research. That will take time. Several years potentially. Then researchers will have to start using it. In the meantime the CCC will continue to be used. For some time after that, probably years, CCC and SEID are likely to be used side by side, just as CCC and Fukuda (with PEM) are now.

Most of the best research these days is CCC. When was the last time we saw anything good from Fukuda cohorts?

In the long term SEID is potentially a dud definition because the advancing science will make it obsolete. However this also applies to every other definition we have.

Now psych studies in the UK still use Oxford. That is likely to continue as they seem cut off from the main research. Or when they use other criteria they use operationalized versions that turn the criteria into something almost unrecognizable, like they did with the London ME criteria in the PACE trial. I think the P2P got this point right - its time for Oxford to be retired as a definition.

PS. So no, I don't have concrete data. Nobody is tracking this stuff. I put this reasoning out for commentary. If anyone has reason or evidence to think its wrong they can reply.

To answer my own question, I just did a quick review of about 50 CFS studies over the last 5 years (the ones I could get full text for and thus see how they picked out cohorts). By far and away, the most used criteria is Fukuda (90%). CCC is about 10%. Oxford is about 8%. ICC is about 4%. Researchers were most likely to use other definitions in combination with Fukuda.

 

[Nielk]

Researchers were most likely to use other definitions in combination with Fukuda.

i wonder what they mean when they state that. Does it mean that each and every patients fit bothe criteria? Or does it mean that some fit one and others fit the second criteria?

 

[alex3619]

I have been thinking about Fukuda. Its a research definition. So it might be that SEID wont replace it. What does this mean? Does it mean that SEID will sit alongside Fukuda?

 

[Denise]

i wonder what they mean when they state that. Does it mean that each and every patients fit bothe criteria? Or does it mean that some fit one and others fit the second criteria?

@Nielk - very good point.
Also while some studies claim to use a particular definition (or more than one), some researchers alter definitions at will. I believe that some studies claimed to use the CCC but the participants only had to have CCC symptoms for one week.

 

[alex3619]

some researchers alter definitions at will

Non standard operationalization. We need not only definitions, but operationalized definitions, so that researchers cannot do this.

 

[Denise]

Non standard operationalization. We need not only definitions, but operationalized definitions, so that researchers cannot do this.

@alex3619 I agree that research must be done correctly. To clarify (and I apologize for not being clear above) I was pointing out to @Caldeonia that sometimes just because studies say they used X definition, they may not really have done so.

 

[alex3619]

@alex3619 I agree that research must be done correctly. To clarify (and I apologize for not being clear above) I was pointing out to @Caldeonia that sometimes just because studies say they used X definition, they may not really have done so.

Yes, like PACE.

However there is a claim going round, that I have not verified, that a lot of studies lately that were using Fukuda have been requiring mandatory PEM. So even Fukuda studies might not be using Fukuda. Its a muddle.

 

[Denise]

Yes, like PACE.

However there is a claim going round, that I have not verified, that a lot of studies lately that were using Fukuda have been requiring mandatory PEM. So even Fukuda studies might not be using Fukuda. Its a muddle.

PACE, Wyller's studies.... And the last thing this disease needs is sloppy research.

If you do find out more about studies purporting to use Fukuda yet requiring PEM, please let me know about them.

 

[Nielk]

I have been thinking about Fukuda. Its a research definition. So it might be that SEID wont replace it. What does this mean? Does it mean that SEID will sit alongside Fukuda?

This a good point, Alex. Does it say anywhere in the report that the IOM criteria are replacing Fukuda?

 

[alex3619]

This a good point, Alex. Does it say anywhere in the report that the IOM criteria are replacing Fukuda?

I had a quick look and didn't find it. It looks like anything outside of the terms of reference is not considered. In other words its up to HHS to decide. They could keep Fukuda for research and use SEID for clinical diagnosis if they wanted to. Does anyone have any better information than this?

Hmmm, have they left the door open for us to push ICC as a proposed new research definition? It looks like it. A lot of that might depend on the P2P though, and we have to wait to see their final report.

A big part of what choices are made are up to the HHS. The organization that lied about what it was doing regarding the IOM. The organization that has ignored our situation for decades. Maybe they will get it right this time. Maybe. If they want our trust they are going to have to earn it.

 

[Dolphin]

Researchers were most likely to use other definitions in combination with Fukuda.

i wonder what they mean when they state that. Does it mean that each and every patients fit bothe criteria? Or does it mean that some fit one and others fit the second criteria?

Generally what it means is that all would fit Fukuda and some of them others. Except with a broader definition again like the Oxford criteria where all would satisfy the Oxford and some would satisfy other criteria incl. Fukuda.

 

[Dolphin]

Yes, like PACE.

However there is a claim going round, that I have not verified, that a lot of studies lately that were using Fukuda have been requiring mandatory PEM. So even Fukuda studies might not be using Fukuda. Its a muddle.

I have heard of one research group in the UK who do this.

 

[Sean]

By far and away, the most used criteria is Fukuda (90%). CCC is about 10%. Oxford is about 8%. ICC is about 4%.

Perhaps the more important question here is: Do studies using the Oxford criteria have a disproportionate influence on medical and government policy?

Certainly seem to in some countries, like the UK.

 

[medfeb]

This a good point, Alex. Does it say anywhere in the report that the IOM criteria are replacing Fukuda?

Its admittedly fuzzy but my understanding is that SEID is not intended to replace Fukuda but that patients that meet SEID are intended to be pulled out of Fukuda. That means that Fukuda minus PEM could continue to exist. Not clear what that means in terms of CDC's CFS website or the use of Fukuda in research. This needs to be clarified.

i wonder what they mean when they state that. Does it mean that each and every patients fit bothe criteria? Or does it mean that some fit one and others fit the second criteria?

At P2P, Nacul recommended that in research, they use the combination of Fukuda plus CCC - patients must meet both.

Perhaps the more important question here is: Do studies using the Oxford criteria have a disproportionate influence on medical and government policy?

In the 2014 AHRQ Evidence Review, Oxford studies led to treatment recommendations for CBT and GET. The AHRQ Evidence Review said that the report was intended to inform a research agenda but also stated that evidence review reports could be used to inform health plans, providers, and purchasers.