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Germany: IQWIG Report to government on ME/CFS - feedback on Report Plan due 11 Aug 2021

Discussion in 'Other reviews with a public consultation process' started by Hutan, Jul 1, 2021.

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  1. MSEsperanza

    MSEsperanza Senior Member (Voting Rights)

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    Good ideas -- thanks @Michiel Tack.

    Just to clarify:

    The IQWiG invited German patient organizations to a meeting at the begining of the project and there will be more meetings on some occasions.

    See here:

    https://translate.google.com/translate?sl=auto&tl=en&u=https://www.iqwig.de/faq-zum-mecfs-projekt/

    And:


    https://translate.google.com/transl...www.iqwig.de/sich-einbringen/stellung-nehmen/

    "The (optional) scientific discussion"

    So there is some form of participation but not cooperation -- as you pointed out, not comparable e.g. to NICE where patient representatives are on the committee.
     
    Last edited: Aug 6, 2021
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  2. Andy

    Andy Committee Member (& Outreach when energy allows)

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    It would be great but my personal opinion is that I can't see us having the capacity to take anything else on in the near future.
     
  3. MSEsperanza

    MSEsperanza Senior Member (Voting Rights)

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    Got a reply from the DG. They won't publish their comment prior to the publication by the IQWiG but sent me some hints on their main points. That's very helpful and much appreciated.

    I will need to focus now on putting a comment together. So apologies if I won't provide further information about the DG's comment.

    Details on the process and how people can get involved can be found here:

    https://translate.google.com/translate?sl=auto&tl=en&u=https://www.iqwig.de/faq-zum-mecfs-projekt/

    orginal page: https://www.iqwig.de/projekte/n21-01.html
     
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  4. petrichor

    petrichor Senior Member (Voting Rights)

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    The plan doesn't mention an assessment or consideration of the quality of outcome measures for ME/CFS (like for example SF-36 or the Chalder fatigue scale). So if someone submits a comment they can mention that, if they want.

    The cochrane handbook chapter on patient reported outcomes could be cited:

    Johnston BC, Patrick DL, Devji T, Maxwell LJ, Bingham III CO, Beaton D, Boers M, Briel M, Busse JW, Carrasco-Labra A, Christensen R, da Costa BR, El Dib R, Lyddiatt A, Ostelo RW, Shea B, Singh J, Terwee CB, Williamson PR, Gagnier JJ, Tugwell P, Guyatt GH. Chapter 18: Patient-reported outcomes. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.2 (updated February 2021). Cochrane, 2021. Available from www.training.cochrane.org/handbook.
     
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  5. MSEsperanza

    MSEsperanza Senior Member (Voting Rights)

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    It’s quite a challenge that the comment has to be in German and the discussion here has to be in English – but I’ll try. Text in English has been automatically translated by deepl (reduced structure) or google translate (table of contents).

    The report plan is about the scope (topics) of the knowledge that will be reviewed and how that will be done.

    Here’s the reduced structure of the main part to which I’ll add some of my thoughts and references I plan to use in the following posts.

    More specific comments and questions will follow after that.

    The detailed structure is attached as a PDF document.


    4. Methods

    4.1 Current state of knowledge .

    First, the current state of knowledge on ME/CFS is systematically reviewed. This includes a presentation of results on the following topics:

    a) Complaints / symptoms (including description of relevant symptoms, severity and burden of the disease, description of the course of the disease, consequences of the disease, etc.).


    b) Etiology / causes (including description of underlying pathophysiology)


    c) Epidemiological and care-related aspects (including information on the number of individuals belonging to the target population, including information on incidence of the target disease, density of care, etc.)


    d) Diagnostics (presentation of current diagnostic criteria, e.g., according to published
    guidelines)


    4.2 Evidence mapping of treatment options relevant to care.

    Second, the report includes an evidence mapping (i.e., an overview of the data) of treatment options relevant to the care of patients with ME/CFS with respect to selected patient-relevant outcomes.


    4.3 Benefit assessment

    Third, based on the evidence mapping, an additional benefit assessment will be conducted for 2 specific therapy options for patients with ME/CFS with regard to selected patient-relevant outcomes.


    4.4. Health information

    Fourth, a health information document will be prepared that conveys the relevant knowledge in an understandable way. The health information will be tested in user trials and will be published in the report as well as on the website www.gesundheitsinformation.de.


    Translated with www.DeepL.com/Translator (free version)
     

    Attached Files:

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  6. MSEsperanza

    MSEsperanza Senior Member (Voting Rights)

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    4. Methods

    4.1 Current state of knowledge .

    First, the current state of knowledge on ME/CFS is systematically reviewed. This includes a presentation of results on the following topics:

    a) Complaints / symptoms (including description of relevant symptoms, severity and burden of the disease, description of the course of the disease, consequences of the disease, etc.).

    b) Etiology / causes (including description of underlying pathophysiology)

    c) Epidemiological and care-related aspects (including information on the number of individuals belonging to the target population, including information on incidence of the target disease, density of care, etc.)

    d) Diagnostics (presentation of current diagnostic criteria, e.g., according to published
    guidelines)

    I haven’t understood yet in which way this section on the current state of knowledge will also include clinical trials and systematic reviews of interventions. Treatments will be dealt with in the following two sections.

    But it seems the evidence on the etiology, population, symptoms etc generated in clinical trials and other studies primarily investigating treatments will also be included in the review of evidence for this section:



    4.1.1.3 Study types

    Systematic reviews of randomised controlled trials (RCTs) and diagnostic quality
    studies, evidence-based guidelines, health technology assessment (HTA)
    reports and overviews of reviews are included as the authoritative basis for the systematic
    review of the current state of knowledge (see Section 9.2 of General Methods 6.0 [11]).

    In justified individual cases, if necessary, further documents such as
    Primary studies or systematic reviews of observational studies included (see section 4.1.2.2).


    And that’s how the studies will be evaluated:

    4.1.3 Information evaluation and synthesis

    Each included source is subjected to a quality assessment according to the study type. For example, in the case of systematic reviews, HTA reports, overviews of reviews, and evidence-based guidelines, this is done using selected items of the Oxman and Guyatt index. Among other things, the quality of information procurement and study selection are assessed.

    Any opinion on this section would be highly appreciated: I won’t be able to check if the Oxman and Guyatt Index is fit for the purpose.


    Points for 4.1 that I will address:

    – Symptoms: Fatigue isn’t specified; difficulty to define PEM isn’t mentioned.
    References:

    • Wilshire, C.E., McPhee, G., and the Science for ME CFQ working group (2018), Submission to the public review on common data elements for ME/CFS: Problems with the Chalder Fatigue Questionnaire, https://www.s4me.info/docs/CFQ-Critique-S4me.pdf
    • Submission to the public review on Common Data Elements for ME/CFS: Concerns with the proposed measure of post-exertional malaise (citation)
    – Diagnostic criteria of patient population that will be included are vague: “The patient must have a history of ME/CFS, as defined by the Canadian Consensus Criteria” [12], or other information that suggests the presence of a condition that can be classified as ME/CFS.

    Edit: Language in paragraph 4.13.
     
    Last edited: Aug 9, 2021
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  7. MSEsperanza

    MSEsperanza Senior Member (Voting Rights)

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    4.2 Evidence mapping of treatment options relevant to care.

    Second, the report includes an evidence mapping (i.e., an overview of the data) of treatment options relevant to the care of patients with ME/CFS with respect to selected patient-relevant outcomes.

    – Patient population: ME/CFS diagnosis required for at least 80% of the population. Is that sufficient?

    If I understood correctly what they mean by evidence mapping is to include only clinical trials, studies and reviews that fulfill some basic quality criteria. Only treatments that have been investigated according to these criteria will be assessed in detail.

    So a detailed assessment of the evidence will be done in a second step.

    What’s strange here is that they limited the number of treatments eligible for that next step to two.

    What might be good is that they say the next step will be only done if there is sufficient quality of evidence for any treatment.

    References:

    • Michiel Tack, David M. Tuller & Caroline Struthers (2020) Bias caused by reliance on patient-reported outcome measures in non-blinded randomized trials: an in-depth look at exercise therapy for chronic fatigue syndrome, Fatigue: Biomedicine, Health & Behavior, DOI: 10.1080/21641846.2020.1848262
     
    Last edited: Aug 9, 2021
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  8. Joh

    Joh Senior Member (Voting Rights)

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    I just noticed that all of the NICE links are gone. Does anybody know more?
     
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  9. Joh

    Joh Senior Member (Voting Rights)

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    They are back now! Apparently a glitch. I was worried because of the comments for the IQWiG report.
     
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  10. MSEsperanza

    MSEsperanza Senior Member (Voting Rights)

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    OK, I deleted my post on the NICE thread.

    A pragmatic question: In the comment form it says that for all references we use that aren't already included in the report plan, we need to provide the full texts.

    1. Die Volltexte der in der Stellungnahme zitierten Literatur, die von direkter Relevanz für die Bewertung sind und nicht bereits im zur Anhörung gestellten Dokument zitiert wurden, müssen eingereicht werden.
    That's quite a hurdle. Do they really mean that we need to include the PDFs of all references or will the URL to the full texts be OK if they are free access?

    And as that's quite an extra hurdle for paywalled papers: Will they accept authors' original manuscripts from Research gate instead? Or / and downloads from sci-hub? :cool:
     
    Last edited: Aug 9, 2021
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  11. MSEsperanza

    MSEsperanza Senior Member (Voting Rights)

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    I find it strange that the IQWiG report plan only links to the old NICE guidelines not to the draft.
     
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  12. petrichor

    petrichor Senior Member (Voting Rights)

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    I'm not sure what they mean by that, but if you download a pdf from sci-hub it's the same as the pdf you would've gotten from the journal website, so they can't tell you got it from sci-hub
     
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  13. MSEsperanza

    MSEsperanza Senior Member (Voting Rights)

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    Thanks. Anyway, a lot of extra work and extra bytes.
     
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  14. MSEsperanza

    MSEsperanza Senior Member (Voting Rights)

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    As I don't feel comfortable to post all questions in the fully public area, I now will post specific asks for help and feedback on single draft paragraphs of my comment in the advocacy planning subforum (members only).
     
    Last edited: Aug 9, 2021
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  15. FMMM1

    FMMM1 Senior Member (Voting Rights)

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    Hi MSEsperanza I haven't looked at your query but if you don't get an answer via Science 4 ME then I/Michiel can post here - #MEAction European Union (EU) - there are a lot of members from Germany.

    @Michiel Tack
     
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  16. MSEsperanza

    MSEsperanza Senior Member (Voting Rights)

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    Thanks for your offer @FMMM1 .

    Luckily, I got very helpful answers from S4ME members.

    Many thanks to everyone.
     

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