[Requirements for quality indicators. The relevance of current developments in outcomes research for quality management].

The assessment of the health state in patients and changes in their health state for the purpose of diagnosis, prognosis and monitoring of treatment response plays a central role in clinical practice. Quality criteria for measurements in medicine include validity, reliability, responsiveness, interpretability, and feasibility. High-quality measurement instruments are a prerequisite for evidence-based medicine. Therefore, international outcomes research groups have developed methods for quality assurance and for the standardisation of measurement instruments. Quality indicators are instruments to measure the quality of care. Due to the increasing relevance of quality assessment for all stakeholders in healthcare and due to the political intention to draw relevant conclusions from the assessment of the quality of care, quality indicators must at least meet the same high standards that are required for clinical trial end points. However, independent researchers and clinicians do not engage in the validation and standardisation of quality indicators in Germany; currently, only the AQUA institute (as assigned by the German GBA) deals with this important issue. Current activities concerning the validation of quality indicators do not meet the requirements of evidence-based healthcare. This is a critical barrier to achieving the political goals of quality medicine. Therefore, the authors propose a multi-step, multi-professional, evidence-driven and evidence-generating consensus process on the basis of established methods of outcomes research for the advancement of quality assessment with quality indicators in Germany. All relevant stakeholders should participate in this process.