AbstractIntroduction: Good quality management (QM) and the sound application of EUnetHTA's (European network for Health Technology Assessment) well-established methodology and tools are fundamental prerequisites for reliable and trustworthy joint work. To provide ultimate support and guidance to the assessment teams of EUnetHTA – and further, to ensure a sustainable mode of work for the post-2020 period – a comprehensive web-based so called “EUnetHTA Companion Guide” is established in Joint Action 3.
Methods: The Companion Guide was created using the open source Wiki software “DokuWiki”. We divided the content into five main parts: 1. EUnetHTA's QM concept, 2. QM for rapid Relative Effectiveness Assessment (REA) Pharma, 3. QM for rapid REA Other Technologies (OT) 4. Scientific Guidance & Tools and 5. QMS-related training material. The assessment processes for rapid REA Pharma and OT have been subdivided into single process steps for which the Companion Guide provides standard operating procedures (SOPs), checklists, templates, guidelines and tools. The content of the Companion Guide is continuously subjected to evaluation by means of a structured survey with regard to the achievement of its purpose of ensuring to ensure high-quality HTA reports.
Results: In May 2018, the Companion Guide was launched and is now available to all EUnetHTA partners. It provides central access to all components of the newly established QMquality management system for EUnetHTA. The user has access to training modules that provide information on how to use the Companion Guide. Moreover, the training material enables EUnetHTA partners to build up necessary capabilities for QMquality management, and application of methodologies and tools in the context of EUnetHTA.
Conclusions: The purpose of the Companion Guide is to ensure the production of high-quality HTA reports by providing ultimate support and guidance to the EUnetHTA assessment teams during their joint work. The continuous evaluation will reveal necessary revisions and the need for further developments and guidance.