Guideline-based quality indicators-a systematic comparison of German and international clinical practice guidelines: protocol for a systematic review.

Background: Quality indicators (QIs) are used in assessing the quality of healthcare. Evidence-based clinical practice guidelines (CPGs) are relevant sources for generating QIs. In this context, QIs are important tools to assess the implementation of guideline recommendations. However, the methodological approaches to guideline-based QI development vary considerably. In Germany, the guideline classification scheme of the AWMF (German Association of the Scientific Medical Societies) differentiates between S1-, S2k-, S2e-, and S3-CPGs depending on the methodological approach. Thus, S3-CPGs are consensus- and evidence-based CPGs and have the highest methodological standard in Germany. An analysis of the status quo of reported QIs in S3-CPGs found 35 current S3-CPGs, which report 372 different QIs. Currently, there is no gold standard for the development of guideline-based QIs. To our knowledge, no studies have investigated to what extent guideline-based QIs from different CPGs that are related to the same topic are consistent. The objective of this study is to compare guideline-based QIs and their underlying methodological approaches of German S3-CPGs with those of topic-related international CPGs.

Methods: Based on the previous identified German S3-CPGs (n = 35), which report quality indicators, we will conduct systematic searches in the guidelines databases of G-I-N (Guidelines International Network) and NGC (National Guideline Clearinghouse) to identify international CPGs matching the topics of the S3-CPGs. If necessary, we will search additionally the websites of the particular CPG providers for separate documents with regard to QIs. We will include evidence-based CPGs which report QIs. Reported QIs as well as methods of development and the rationale for QIs will be extracted and compared with those of the S3-CPGs.

Discussion: This study will be part of the project "Systematic analysis of the translation of guideline recommendations into quality indicators and development of an evidence- and consensus-based standard," supported by the German Research Association (DFG). The results of this analysis will feed into a subsequent qualitative study, which will consist of structured interviews with developers of international CPGs. Further, the results will be considered in a consensus study on standards of the translation of guideline recommendations into quality indicators in Germany.