[Adverse Effects in Implementation Research: Safety and System Impacts in German Innovation Fund Projects]

For transfer decisions concerning Innovation Fund projects into routine care, evidence of effectiveness alone is often insufficient, because unintended consequences and system-level effects may also be decision-relevant. This study aimed to systematically characterize the extent to which harms and balancing measures were defined, measured, and reported in completed Innovation Fund projects that received a positive recommendation for transfer to routine care.

We conducted a cross-sectional document analysis of completed Innovation Fund projects with a positive transfer recommendation (cut-off date 9 January 2026; n=28). Final outcome and evaluation reports were coded using a three-tier harms/balancing template: Tier 1 (safety), Tier 2 (rights/access/trust/equity), and Tier 3 (feasibility/resources). We assessed reporting status (yes/no/not applicable), reporting quality (RQ 0-2), and the practical relevance of potential negative effects or trade-offs (M 1-3/unclear); results were analysed descriptively.

Seventeen of 28 projects used randomized designs, including seven cluster or stepped-wedge cluster randomized controlled trials offering a potentially stronger basis for causal assessment of harms; 11/28 were non-randomized. Information on the definition and/or surveillance of safety-relevant events was missing in 4/28 projects (RESIST, PROMPt, ZSE-DUO, TRANSLATE-NAMSE). Harms and balancing domains were frequently addressed overall; however, reporting quality varied substantially across projects and domains.

The transfer-recommended project corpus shows a methodologically strong evidence base, yet uncertainties relevant to scaling decisions remain with respect to harms and balancing measures. Future funding and transfer decisions should require a mandatory core set of harms/balancing indicators, including defined surveillance and incident-reporting processes.