German Guideline Appraisal Instrument DELBI

Since development of high quality clinical practice guidelines (CPGs) is intricate harmonisation of CPG methodology is desirable to facilitate international cooperation.

The AGREE (Appraisal of Guidelines Research and Evaluation) instrument, developed and validated by a group of researchers from 13 countries, including Germany, provides a framework for standardised CPG development, reporting and assessment. Therefore, the German checklist “Methodological Quality of Guidelines” was updated with regard to adoption and linguistic validation of the AGREE instrument. However, the framework for CPGs on a national level is also determined by the structures of the individual healthcare system, experiences from national CPG programmes and the expertise of active CPG working groups.

The "German Instrument for Methodological Guideline Appraisal (DELBI)"

was therefore developed in cooperation of the Association of the Scientific Medical Associations (AWMF), the Agency for Quality in Medicine (AEZQ/AquMed) and a multidisciplinary group of CPG experts.

It is based on:

• conceptual analysis and revision of the AGREE instrument, with a representative of the AGREE group proposing interpretation for the items
• pilot test on 3 CPGs, each assessed by 15 representatives of the projected user group open review via an internet forum
• revision maintaining conceptual equivalence, backward translation (DELBI-English version).

The quality criteria (items) of the first 6 domains of DELBI are equivalent to those of AGREE. However, putting emphasis on the educational aspect of the instrument and its applicability in Germany, some modifications and amendments were made. The order of item responses is presented from 4 (strongly agree) to 1 (strongly disagree) by AGREE. This is vice versa in DELBI intending to gradually accelerate the demands. DELBI provides more detailed information on the background to the items and the requirements needed to be fulfilled for individual response categories to ensure adequate use of the instrument without parallel use of a training manual.

Additional references are given to facilitate discrimination between categories 2 (disagree) and 3 (agree). The requirements target higher than AGREE in criteria with particular relevance and/or potential for improvement as known from CPG appraisal in Germany. This applied, for example, to items addressing stakeholder involvement and evidence-synthesis.

Recognising that the effectiveness of CPGs does not only relate to their internal validity but also to their acceptance and implementation and that these features are poorly addressed by CPG developers, 6 new criteria were added (domain 7). They focus on presentation of methodology (availability of a guideline-report), content recommendations covering the diagnostic and therapeutic chain in different health care settings, clinical algorithms), and strategies for CPG dissemination and implementation. Pilot testing of DELBI turned out satisfactory concerning acceptance, construct validity and reproducibility. Item equivalence in domain 1-6 will allow for comparability to AGREE results.

Field testing is planned to prove reliability of the instrument.

The use of DELBI is recommended to both, guideline developers and their potential users- health care professionals, patients, policy makers and other interested parties. It is meant to assist a prospective estimation of the validity of a guideline. The definitive value of a guideline for patients, health care professionals and the health care system can only be judged based on evaluation including its content quality, implementation and impact on structures, processes and outcomes of health care.

The English version of DELBI is not meant to compete with or replace the AGREE instrument in the international context. It is intended to inform about the results of a process of adaptation and amendment of the AGREE instrument based on expert consensus, experience and data available from guideline program on the national level in Germany.

Ina Kopp, AWMF 
Guenter Ollenschlaeger, AEZQ

Comments are most welcome delbi@azq.de