Implications of living evidence formats for coverage decisions in the German health care system

Abstract

Decision-makers consult systematic reviews and clinical guidelines to make informed coverage decisions based on the current state of evidence. Outdated recommendations in rapidly evolving areas such as lung cancer treatment, are challenging. The COVID-19 pandemic highlighted the need for good decision-making under uncertainty. The descriptive analysis of two samples of evidence bases for evidence synopses to prepare the decision on appropriate comparators shows that living systematic reviews and living clinical guidelines are rare (41/5,463; 0.75%) but present, with COVID-19 being the most common indication. We also describe some characteristics and quality issues of these living formats in the German context. We note an overlap between living and rapid formats, where updates may not adhere to methodological standards in evidence selection, appraisal and formulation of recommendations, or may lack transparency in their methodological processes. The need for critical appraisal of living formats is highlighted as crucial aspect. The production of living systematic reviews and clinical guidelines requires considerable resources and expertise. While there is a need for timeliness in decision making, especially in situations of high uncertainty such as the COVID-19 pandemic, the trade-off between time and quality needs to be balanced. The focus should therefore be on how best to select and process recommendations that are relevant for updating and those that are not. Regularly updated systematic reviews and clinical guidelines that adhere to recommended standards are important for decision-making bodies such as the Federal Joint Committee (G-BA). Transparent documentation of the process and methods used increases confidence in decision-making, even when the evidence base is not perfect.

Keywords: Decision-making; Entscheidungsfindung; Evidence based medicine; Evidenzbasierte Medizin; Gesundheitsplanung; Health planning; Lebendige Leitlinien; Lebendige systematische Übersichten; Living guidelines; Living systematic reviews; Methoden; Methods; Time factor; Zeitfaktor.