Germany: IQWIG Report to government on ME/CFS - report out now May 2023

Hutan

Hutan

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From the News from Germany thread:
alexoffline said:
The IQWIG revealed their method of creating a report about the current situation of ME/CFS for the german government.

https://www.iqwig.de/download/n21-01_me-cfs-aktueller-kenntnisstand_berichtsplan_v1-0.pdf?rev=209654

I wonder if we have any members here who are familiar with such a process. First of all its disappointing that they want to publish a first version of this report in summer 2022. And after that it will take another year until the report is finalized and sent to the government. Nothing will change for ME/CFS in germany until they have this report in 2023.

However the most worrying part about it is... what if after 2023 they are finally done with the report and come to the conclusion that CBT/GET are an effective treatment for ME/CFS.

On page 17 they say:
"Da es sich bei der vorliegenden Fragestellung um eine Evidenzkartierung handelt, werden keine Aussagen zum Nutzen und Schaden getroffen. Jedoch wird – falls sich Evidenz in ausreichender Qualität abzeichnet – eine Auswahl von 2 Therapieverfahren getroffen, für die Nutzenbewertungen durchgeführt werden (siehe nachfolgenden Abschnitt)."

"[...], no statements on benefits and harms [of therapeutic programs] are made. However, if evidence of sufficient quality emerges, a selection of 2 therapeutic programs will be made to evaluate if they are useful (see following section)."

And I really cant shake off this bad feeling that they already paved the way for a CBT/GET homage with this sentence.

We still have a month time to give them a feedback. I have to admit that I'm out of the loop with all the studies for ME/CFS especially regarding CBT/GET so I can't tell if there are harmful studies out there, that would actually be included in their evaluation by their criteria.

I'd be happy to help with translating the important parts of this pdf if anyone here is knowledgable enough to interpret it.

Following critera need to be matched for a study to be evaluated in their report:
1. Patients with ME/CFS (at least 80% of the patients in the study need to have ME/CFS)
2. Results of a therapy program are for ME/CFS
3: study needs to be randomized controlled trial, have evidence based guidelines and a HTA report.

We have 1 month to give them our feedback.
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Update provided by a forum member 23/10/22:

The forum discussion on the draft IQWiG report, due 27 November 2022 starts here:

https://www.s4me.info/threads/germa...-by-11-november-2022.21266/page-2#post-441477


The European ME Coalition's (EMEC) draft comment is posted here :

https://www.s4me.info/threads/germa...-by-11-november-2022.21266/page-5#post-443155


The relevant IQWiG documents, machine translations provided by forum members:

Preliminary report: Current scientific knowledge on ME/CFS

-- includes appreciation of the public hearing (summary) starting p. 210 (google translate)
-- includes health information, starts p. 275

https://www.s4me.info/threads/help-...e-cfs-due-27-november-2022.29968/#post-441532

Documentation of comments [public hearing, including oral discussion] on the report plan

Includes discussion on patient relevant outcome measures starts p. 24 (google translate)

https://www.s4me.info/threads/help-...due-27-november-2022.29968/page-2#post-441689


I think it's useful to check whether critique can be backed up by referring to the general methods they use as their working base:

General methods paper, English version provided by IQWiG:

https://www.iqwig.de/methoden/general-methods_version-6-1.pdf


Template for comments (German version) and general info in English language about comments can be found here :

https://www.iqwig.de/en/projects/n21-01.html


Forum members' comments and support are much appreciated.


A members only thread for more technical questions and support for people who want to submit a comment is here:

https://www.s4me.info/threads/germa...-by-11-november-2022.21266/page-5#post-443155


Please keep in mind that the few people involved in putting comments together might struggle with PEM, heavy brainfog etc.

It's helpful to keep the discussion as succinct as possible.
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From the press release:
"Myalgic encephalomyelitis / chronic fatigue syndrome: IQWiG invites comments on the report planThe BMG has commissioned the Institute to present the current state of scientific knowledge on ME/CFS. Now the Institute is releasing its intended working method for comment.

On behalf of the Federal Ministry of Health (BMG), the Institute for Quality and Efficiency in Health Care (IQWiG) is compiling the current state of scientific knowledge on the disease myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS).

In the first phase of the two-year project, the Institute prepared the report plan, i.e. documented the methods it will use for the report. Comments on this document can be submitted until 11.08.2021."
 
Is there any way there could be an interim warning of there being evidence of harm for some participants in GET and CBT aimed at treating/curing the underlying ME/CFS?

We singularly failed to achieve this in relation the NICE guidelines for ME/CFS during their rewriting process here in the UK, but NICE did add a provisional warning against GET to their interim Covid guidelines.
 
obviously the most important part is what diagnostic criteria for ME/CFS has been used in the studies to be considered a study they include in their report. They only say "for example canadian consensus criteria or other data that makes it plausible that the patients had ME/CFS"

I think thats already too vague. Its not like we have 1000 good diagnostic criterias... plus the free ticket of just making it sound plausible that they had ME/CFS is worrying, too.
Is there any good study out there that is beneficial for ME/CFS that didnt use CCC or ICC? Because otherwise my first critique would be to already determine which criteria they will accept and be strict with it with no room to play around. Keep in mind they will only include studies post 2011 anyways.
 
To update the development:
The IQWiG wanted to include 3 Experts for ME/CFS for their review.
They changed that to two doctors who are familiar with ME/CFS and a psychiatrist or psychotherapist who is familiar with ME/CFS.
I contacted a known psychiatrist in germany who says that CBT/GET are trash. He replied that he already applied but they denied him because of conflict of interest. They refused to give a further explanation what kind of conflict of interest there is.
They also refuse to work together with patientorganisations.

So its pretty clear, they are supposed to praise CBT/GET and prepared everything to do so.

edit:
I have to edit the list of doctors they are looking for. They initially looked for 2 doctors who are experts for me/cfs and changed it to:
1 doctor who is an me/cfs expert (they state for example internist or virologist)
1 GP who just knows me/cfs
1 Psychiatrist/Psychotherapist who knows me/cfs

thanks @Joh for pointing this out
 
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alexoffline said:
On page 17 they say:
"Da es sich bei der vorliegenden Fragestellung um eine Evidenzkartierung handelt, werden keine Aussagen zum Nutzen und Schaden getroffen. Jedoch wird – falls sich Evidenz in ausreichender Qualität abzeichnet – eine Auswahl von 2 Therapieverfahren getroffen, für die Nutzenbewertungen durchgeführt werden (siehe nachfolgenden Abschnitt)."
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deepl translate:

"Since the present research question is an evidence mapping, no statements on benefits and harms [of therapeutic programs] are made. However, if evidence of sufficient quality emerges, a selection of 2 therapeutic programs will be made to evaluate if they are useful (see following section)."

Not sure if I understood correctly but I can find this quote only on p. 10 (not 17) [p. 8 of the translated version] and it seems to only refer to the section 4.2. "Evidence mapping of therapy options relevant to health care provision". It's from that section's chapter 4.2.3 "Information procurement".

Details on how to assess benefits and harms are given in the following section 4.3 "Benefit Assessment" / esp. chapt. 4.3.3 "Information evaluation and synthesis".

alexoffline said:
And I really cant shake off this bad feeling that they already paved the way for a CBT/GET homage with this sentence.
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I'm too brain-fogged ATM to understand this report plan's structure and much of its content. I too think it's weird how they anticipate the number of "therapeutic programs" for which there may be sufficient quality of evidence.
 
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I will try to post some thoughts on the report later. I have not the expertise to understand most methodological details though.

Any thoughts, help, comments would be highly appreciated.

Apologies for the short notice – have been struggling with diverse issues lately and still do, but I hope I will be able to submit some points that might not be sufficiently covered by others’ submissions.

I realize the date for submissions collides with the date for comments on the NICE guidance’s final version.

Hope that the automatic translation isn’t too difficult to understand even for those of you who have the methodological expertise.

alexoffline said:
Here is the document translated with deepL which usually produces better results than google translate
https://1drv.ms/b/s!AohT_k4FnlZ-hBt1MkxzGTFWtjtd?e=2LcvbX
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(Edited for clarity and to add PDF of the report plan -- thanks to @alexoffline for the deepl translation and sharing it on OneDrive.)
 

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Further comments will also be possible on the preliminary report -- but before the publication of the preliminary report (draft) there will be a "user testing".

I haven't understood yet how people for the "user testing" will be elected.

4.4.4 User testing
Prior to the publication of the preliminary report, a qualitative user test of the health information carried out by an external service provider.

For this purpose, focus groups or individual interviews with affected persons and experts will be conducted. The criteria for the focus groups and the questions are developed in cooperation with the external service provider.

The aim is to check the acceptance, comprehensibility and completeness of the health information so that
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(Edit: typos/ grammar)
 
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alexoffline said:
To update the development:
The IQWiG wanted to include 3 Experts for ME/CFS for their review.
They changed that to two doctors who are familiar with ME/CFS and a psychiatrist or psychotherapist who is familiar with ME/CFS.
I contacted a known psychiatrist in germany who says that CBT/GET are trash. He replied that he already applied but they denied him because of conflict of interest. They refused to give a further explanation what kind of conflict of interest there is.
They also refuse to work together with patientorganisations.

So its pretty clear, they are supposed to praise CBT/GET and prepared everything to do so.

edit:
I have to edit the list of doctors they are looking for. They initially looked for 2 doctors who are experts for me/cfs and changed it to:
1 doctor who is an me/cfs expert (they state for example internist or virologist)
1 GP who just knows me/cfs
1 Psychiatrist/Psychotherapist who knows me/cfs

thanks @Joh for pointing this out
Click to expand...

I dont know if it's OK to name names, but aside from e.g. Dr Chirazi Stark, have you heard of Dr Leussink in Meerbusch (neurologist)?

How does this work - do ME doctors have to apply there or is the iqwig approaching them?
 
Andy said:
Are there any limitations as to who can submit feedback?
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It has to be in German language and anonymous comments aren't allowed.

Edit: Further details here: (google translate)

Your statement must meet certain formal requirements so that we can take it into account:
  • Eligible Participants: Anyone who has an interest in a particular evaluation can submit an opinion on thehand in standing documents, ie so-called natural persons (= private persons) and legal persons (= companies, institutions and companies). In the case of legal persons, the respondent must also give his or her name.
  • Form of the statement: Statements must be submitted to IQWiG in writing, in German, by the deadline and using the " Submission for a statement " form . Further information on data protection aspects can be found in this form and under the point "Information on data protection for respondents".
  • Deadlines: [...]
  • Submission of the statement: Please submit the statement documents to IQWiG preferably by e-mail and ideally in PDF format , specifying the project number and document type in the subject . In exceptional cases, the statement can also be submitted by post.
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https://translate.google.com/transl...www.iqwig.de/sich-einbringen/stellung-nehmen/

I'll attach the template (deepl translate) for futher details.

Link to the original template here.
 

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"The German ME/CFS Society [Deutsche Gesellschaft für ME/CFS -- DG ME/CFS] have submitted a 25-page comment on the reporting plan of the @iqwig . The comments will be published by IQWiG."

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Code: 
https://twitter.com/dg_mecfs/status/1423564303265828864

I asked the DG ME/CFS this afternoon if I could have a look at their comment. Would make things much easier.

@Joh
 
MSEsperanza said:
"The German ME/CFS Society [Deutsche Gesellschaft für ME/CFS -- DG ME/CFS] have submitted a 25-page comment on the reporting plan of the @iqwig . The comments will be published by IQWiG."



Code: 
https://twitter.com/dg_mecfs/status/1423564303265828864

I asked the DG ME/CFS this afternoon if I could have a look at their comment. Would make things much easier.

@Joh
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If it looks like the submission by the Deutsche Gesellschaft für ME/CFS is something we could get behind, would it be worth us submitting a short comment primarily endorsing what they say?
 
It might be good to ask for patient representatives to be involved in the making of this guideline. You could refer to NICE or the Dutch guideline as examples of this.

Patient representatives can point out flaws or potential problems more rapidly when the report is still being written, which is likely a more effective method than only allowing comments on a draft version.

There are several influential publications that recommend involving patients in the creation of medical guidelines such as the Appraisal of Guidelines for Research and Evaluation (AGREE) and The Guideline International Network (GIN) documents. The following citations might be useful:

[1] Brouwers M, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, et al. AGREE II: advancing guideline development, reporting and evaluation in healthcare. CMAJ. 2010;182:E839–42.​

[2] Boivin A, Currie K, Fervers B, Gracia J, James M, Marshall C, Sakala C, et al. Patient and public involvement in clinical guidelines: international experiences and future perspectives. Qual Saf Health Care. 2010 Oct;19(5):e22.​

[3] Committee on Standards for Developing Trustworthy Clinical Practice Guidelines, Graham R, Mancher M, Miller Wolman D, Greenfield S, Steinberg E, eds. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press; 2011.​

[4] Armstrong MJ, Mullins CD, Gronseth GS, Gagliardi AR. Impact of patient involvement on clinical practice guideline development: a parallel group study. Implement Sci. 2018 Apr 16;13(1):55.​
 
Peter Trewhitt said:
If it looks like the submission by the Deutsche Gesellschaft für ME/CFS is something we could get behind, would it be worth us submitting a short comment primarily endorsing what they say?
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I hope they will either publish the comment on their website on the weekend or if they don't want to publish it until the IQWiG will publish it, will send me a copy in confidentiality.

To clarify: I made all my posts here just as a simple forum member and private person, assuming that for any official submission on behalf of S4ME it is not enough time now. So just welcome any help and if I submit anything, would also mention that I put the feedback together with the help of individual forum members, and would be happy to name anyone who wanted to be named.

Or if someone wanted to submit an individual comment but needs someone to translate or edit, I would do my best to find a good translator or editor.

For any action on behalf of S4ME I think that would need to be agreed upon by the committee.

Actually, I think it would be great if S4ME wanted to be involved in the next steps, and would also be great if S4ME could reach out to the DG to exchange information. @Andy @Trish
 
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