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Philipps-Universität Marburg
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Abstract
The internal validity is a prerequisite for the acceptance and implementation of guidelines. The internal validity includes the methodological and content quality. The methodological quality consists of two core elements (systemic review and appraisal of the evidence and structured consensus of a representative, multidisciplinary group). The quality of content also consists of two core elements (mapping of the current state of knowledge and the absence of unexplained contradictions to other relevant sources of knowledge).
In Germany, guidelines are classified into classes S1, S2, and S3, according the underlying rigour of development. The S1 class represents recommendations for action of expert Groups. S2 guidelines are characterised by formal consensus with the participation of the potential guideline users. The highest class constitutes S3 guidelines, which are expected to meet at least 5 criteria of systematic development: consensus, algorithmic logic, systemic review and appraisal of the evidence, outcome-analysis, decision analysis.
Consensus-based guidelines (S2) by definition lack the systematic evidence base. Therefore, the question was:
Does the lack of systematic evidence-basing in the creation of the guideline recommendations on content quality?
The question was operationalised by content analysis and comparison between systematically selected guidelines and Systematic Reviews published via the Cochrane Library.
12 S2-AWMF guidelines (308 key recommendations), 8 GIN guidelines (78 key recommendations) and 18 Systematic Reviews (18 conclusions) were included. The assessment of methodological quality of the consensus-process by DELBI- criterion 10 showed better overall results in the S2 guidelines as in GIN guidelines. The assessment of methodological quality of systematic reviews by Oxman-Guyatt index showed overall good results, so that it can be assumed that they represent a very solid evidence base for the content comparisons. Potential contradictions to recommendations of S2-guidelines were found in 2 G-I-N guidelines (4 key recommendations) and in 5 systematic reviews (5 conclusions). This result is not worrisome, especially considering the comparable total numbers of key recommendations and relatively low relevance of contradictions. Different content was found mainly in areas of uncertain evidence (e.g. safety distances at melanoma excision, photodynamic therapy for basal cell carcinoma) or different interpretations of the evidence (e.g. use of immunoglobulins or corticosteroids in sepsis).
The possible reasons for the differences can also be due to a higher influence of clinical experience in consensus-based guidelines. However, the sample was relatively small with a narrow confinement period. Thus the representativeness of the study was restricted. Furthermore, was limited research on secondary literature.
The analysis of the internal validity of the guidelines in particular reference to the evidence base is feasible, but very costly. For an overall evaluation of the guidelines methodological and content aspects must be considered. Just guideline developers should be familiar with the methodology and content quality standard yet! They should be encouraged and asked for it. Peer review and expert interviews as alternative ways to assess the substantive quality of guidelines for example on the basis of external appraisals, field tests or public consultation should be verified in studies.
Clinicians and specialists in evidence-based medicine should work with the guideline development go hand in hand. So the balance between content and methodology focusing on the development of guidelines could succeed.
In this context, the aspect of the "globalisation" of guideline development should be mentioned. At the same rate, is resorted to as international studies, you should find an international consensus in the development of guidelines. A certain degree of flexibility must be possible and must be given in parts of alternatives to be considered national or population-specific features.
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Dates
Created: 2015Issued: 2015-11-30
Faculty
Medizin
Publisher
Philipps-Universität Marburg
Language
ger
Data types
DoctoralThesis
Keywords
ValidityGuideline Recommendations
DFG-subjects
Norm Validität
DDC-Numbers
610
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Eltahir, Husam: Analyse der internen Validität der Leitlinienempfehlungen. : Philipps-Universität Marburg 2015-11-30. DOI: https://doi.org/10.17192/z2015.0587.
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This item has been published with the following license: In Copyright