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Germany: IQWIG General Methods Handbook - submissions due on draft now 28 February 2023

Discussion in 'Advocacy Action Alerts' started by Hutan, Dec 14, 2022.

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  1. Hutan

    Hutan Moderator Staff Member

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    (Thread created at the request of a member)

    IQWIG
    The independent Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) examines the benefits and harms of medical interventions for patients.


    https://www.iqwig.de/en/about-us/methods/methods-paper/
    "The General Methods describe the basic work procedures of the Institute. They describe in detail, among other things, the scientific principles followed by IQWiG, the sequence of the individual steps followed in the production of the work results, the procedure of the collaboration with external experts and how IQWiG's results are published."

    "The Institute has presented the draft of the next revision of its General Methods. Interested persons and institutions can submit comments on the contents of the updates and amendments in the draft of version 7.0."


    Comments on the methodology presented here may be submitted by 2023-01-31 (12 pm) to the following e-mail address: methoden@iqwig.de

    The draft handbook and a template for submissions is at the link.

    The methodological update may be too late to influence IQWIG's report on ME/CFS, but improving national methodologies that evaluate the evidence for health interventions can only be helpful for us.
     
    Hutan, Dec 14, 2022
    #1
    ContraindiKate, bobbler, alktipping and 4 others like this.
  2. MSEsperanza

    MSEsperanza Senior Member (Voting Rights)

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    Thanks Hutan.

    As IQWiG provides only the German version of the draft handbook I attach the machine translation into English.

    If you'd like to compare, here's the direct link to the English version of the currently used methods handbook:

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


    List of changes:




    Attached file: Draft General Methods Version 7.0 (deepl translate)
     

    Attached Files:

    Last edited: Dec 16, 2022
    MSEsperanza, Dec 15, 2022
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  3. MSEsperanza

    MSEsperanza Senior Member (Voting Rights)

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    Some context why I think it would be helpful if forum people could submit a comment -- perhaps focusing on two points:

    1) Why patient participation matters -- how this needs to be improved:


    2) Why results from clinical research with a certain trial design that's particularly common in some areas of medicine /psychology/ physical therapy mustn't be allowed to be seen as providing sufficient evidence in favor of any treatment.

    (It's not enough to downgrade quality of evidence but results produced by this kind of trial design can't be taken into account for treatment recommendations, or in only well-defined exceptions)

    See:
    To coordinate comments or co-work on a submission perhaps best use the existing members-only thread on the IQWIG report on ME/CFS.


    edit: wording
     
    Last edited: Dec 16, 2022
    MSEsperanza, Dec 16, 2022
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  4. Esther12

    Esther12 Senior Member (Voting Rights)

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    This is the sort of thing it makes sense to try to engage with, but it can also be difficult for patients to do so, particularly when so when it many other things can seem more pressing. Which is one reason why so many systems and standards in medical research can driven by the self-interests of researchers.
     
    Esther12, Dec 17, 2022
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  5. Trish

    Trish Moderator Staff Member

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    Trish, Jan 16, 2023
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  6. MSEsperanza

    MSEsperanza Senior Member (Voting Rights)

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    MSEsperanza, Jan 27, 2023
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  7. MSEsperanza

    MSEsperanza Senior Member (Voting Rights)

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    MSEsperanza, Feb 1, 2023
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  8. MSEsperanza

    MSEsperanza Senior Member (Voting Rights)

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    I thought this review by IQWiG staff could be relevant to the discussion on an appropriate outcome measure for ME/CFS – firstly with respect to how clinical significance can differ from a significant change in a measure that is assumed to be relevant but hasn’t been validated for the specific patient group being investigated.

    Secondly, it seems to highlight that for determining appropriate outcome measures the kind of treatment being investigated is relevant.

    (Sorry I realize this seems obvious, but still would be curious to see their reply on a comment asking what the authors of the review think about applying the CDAI in unblindable trials, e.g. to investigate an additional effect from physiotherapy/ exercise/ exposure to heat/ cold etc.)
     
    MSEsperanza, Feb 19, 2023
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