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

Hutan

Hutan

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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.
 
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:

In this draft version 7.0, minor errors have been removed and editorial changes and a
literature update have been made compared to version 6.1 of the Institute's "General Methods"
dated Jan. 24, 2022. The following changes in content and structure have taken place:
▪ Renaming of the product "HTA Report" to "TopicCheck Report
▪ fundamental revision of section 1.3 on evidence-based medicine
▪ fundamental revision of section 1.4 on health economics
▪ Presentation of the extended product range with regard to assessments according to §
35a in chapter 2
▪ Fundamental revision and renaming of section 3.2.1 for dealing with possible
reporting bias
▪ Addition to Section 3.3.4 describing the contents of concepts for data collection
accompanying the application in accordance with Section 35a (3b) SGB V (AbD
concepts)
▪ fundamental revision and expansion of section 3.5 on diagnostic procedures
▪ Fundamental revision of chapter 4 on cost-benefit assessment of medical interventions.
▪ Change of instrument for quality assessment of systematic reviews (AMSTAR 2 instead
of Oxman-Guyatt index) in chapter 7.
▪ Additions to section 8.1.1 on the use of machine learning
▪ Addition of the new EMA database "Clinical Trials Information System" in section 8.1.2
▪ Additions and deletions in section 8.2 on standards in focused information
gathering
▪ Additions to section 8.4 on focused information retrieval according to guidelines
▪ Revision of section 9.1.1 on criteria for inclusion of studies
▪ Revision and renaming of section 9.3.2 on statistical significance and confidence
intervals
▪ Additions to section 9.3.6 on adjustment for confounders in the context of data
collections accompanying applications
▪ Additions to Section 9.3.12 on the impact of systematically shortened
observation times when collecting patient-reported outcomes (PROs).
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Attached file: Draft General Methods Version 7.0 (deepl translate)
 

Attachments

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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:

Pustekuchen said:
n the submission of the German Association for ME/CFS they write: "In 2021, IQWiG initially published a call for tenders for two experts. The search was for two medical specialists of any specialty with expertise in ME/CFS. This already published call for tenders has been withdrawn. Instead a new call was published. Now only a medical specialist with expertise in ME/CFS and a psychiatrist and a general practitioner, for whom only "knowledge" of ME/CFS was who instead of "expertise" only "knowledge" of ME/CFS is sufficient."

In an FAQ on their website IQWiG writes:
"Why did IQWiG also look for psychiatrists and psychotherapists in its call for tenders?
Patients repeatedly describe very convincingly that they are confronted with psychiatrists or psychotherapists in the course of care (e.g., in the course of assessments) who do not know their illness, minimize it, or consider it to be primarily psychological, for example, depression. For IQWiG, it is important to understand how these difficulties in understanding and comprehension arise and how they could be remedied."

That's not a fair argument. If they really want to understand "these difficulties in understanding" they need to involve patients equally.
Very much exaggerting, but one wouldn't invite a priest to work on a report evaluating abuse in the catholic church - and only involve those affected in very few and selected questions. Maybe it's not about "understanding and comprehension", but about right and wrong.

I don't know about vested interest - but it's definitely a very weird process.
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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:
MSEsperanza said:
Some comments on the draft of the methods paper included suggestions on dealing with assessing non-pharmacological, unblindable trials that use only subjective outcomes.

The IQWIG replied (machine translation by deepl) :

2.1.4 Appreciation of comments on section 3.4 'Non-pharmaceutical therapeutic interventions'.

"It is certainly desirable if endpoints that can be objectively recorded are also recorded in this way, because this generally increases the reliability and validity of the data collection (e.g. through blinding).

"Conversely, however, patient-reported endpoints, such as pain or quality of life, are of utmost importance for patients and thus also for the assessment of a benefit, although by their nature they can only be recorded subjectively.

"The fact that many symptoms can only be recorded subjectively is also not a disadvantage because ultimately only the patient can evaluate the success of his or her own treatment. If a person learns to rate his or her own symptoms as less severe or threatening, then this can be seen as a genuine relief, since here too it is the subjective patient perspective alone that counts. Overall, therefore, no need for change to the methods paper is seen on this point." (*)

Perhaps the comments could have been worded more clearly. But why is it so difficult for people who are supposed to be experts in assessing evidence in the field of healthcare to see that using only subjective outcomes in open label trials can't produce reliable evidence, and that it would not be too difficult to use both objective and subjective outcomes?
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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
 
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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.
 
MSEsperanza said:
From IQWiG:

"#CDAI is the first choice for measuring treatment effects of disease-modifying #antirheumatic drugs. Using a broad evidence base, a team of IQWiG authors compared measurement tools."

Press release: https://www.iqwig.de/en/presse/press-releases/press-releases-detailpage_84103.html
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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.)
 
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