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

Authors

Afschin Gandjour

Published in

Gesundheitswesen (Bundesverband der Arzte des Offentlichen Gesundheitsdienstes (Germany)). Sep 14, 2026. Epub Sep 14, 2026.

Abstract

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.

PMID:
42735709
Bibliographic data and abstract were imported from PubMed on 15 Sep 2026.

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