[GRADE: Evidence to Decision (EtD) framework for coverage decisions]. / GRADE: Von der Evidenz zur Empfehlung oder Entscheidung ­ Entscheidungen zur Kostenerstattung.

BACKGROUND: Coverage decisions are decisions by third party payers about whether and how much to pay for technologies or services, and under what conditions. Given their complexity, a systematic and transparent approach is needed. The DECIDE project, a GRADE working group initiative funded by the European Union, has developed GRADE Evidence to Decision (EtD) frameworks for different types of decisions, including coverage ones. METHODS: We used an iterative approach, including brainstorming to generate ideas, consultation with stakeholders, user testing, and pilot testing of the framework. RESULTS: The general structure of the EtD includes formulation of the question, an assessment using 12 criteria, and conclusions. Criteria that are relevant for coverage decisions are similar to those for clinical recommendations from a population perspective. Important differences between the two include the decision-making processes, accountability, and the nature of the judgments that need to be made for some criteria. Although cost-effectiveness is a key consideration when making coverage decisions, it may not be the determining factor. Strength of recommendation is not directly linked to the type of coverage decisions, but when there are important uncertainties, it may be possible to cover an intervention for a subgroup, in the context of research, with price negotiation, or with restrictions. CONCLUSION: The EtD provides a systematic and transparent approach for making coverage decisions. It helps ensure consideration of key criteria that determine whether a technology or service should be covered and that judgments are informed by the best available evidence.

A literature-based economic evaluation of healthcare preventable adverse events in Europe.

PURPOSE: To establish from the literature, cost of preventable adverse events (PAEs) to member states of the Joint Action European Union Network for Patient Safety and Quality of Care. DATA SOURCES: We searched MEDLINE, EMBASE and CINAHL for studies in Europe estimating cost of adverse events (AEs) and PAEs (2000-March 2016). Using data from the literature, we estimated PAE costs based on national 2013 total health expenditure (THE) data reported by World Health Organization and converted to 2015 Euros. STUDY SELECTION/DATA EXTRACTION: Information on type, frequency and incremental cost per episode or estimated cost of AEs was extracted. Total annual disability-adjusted life years (DALYs) resulting from PAEs in 30 EU nations were calculated using an estimate from a published study and adjusted for the percentage of AEs considered preventable. RESULT OF DATA SYNTHESIS: Published estimates of costs of AEs and PAEs vary based on the care setting, methodology, population and year conducted. Only one study was from primary care, the majority were conducted in acute care. Nine studies estimated percentage of THE caused by AEs, 13 studies calculated attributable length of stay. We estimated the annual cost of PAEs to the 30 nations in 2015 to be in the range of 17-38 billion Euros, total DALYs lost from AEs as 3.5 million, of which 1.5 million DALYs were likely due to PAEs. CONCLUSION: The economic burden of AEs and PAEs is substantial. However, whether patient safety interventions will be 'cost saving' depends on the effectiveness and costs of the interventions.