Entwicklung eines Instruments zur Bewertung des Verzerrungsrisikos in Gesamtprognosestudien (ROB-OPS): Entwicklung, Pilotierung und Implementierung

• Applicant: Professorin Dr. Nicole Skoetz
• Subject Area: Epidemiology and Medical Biometry/Statistics ; Medical Informatics and Medical Bioinformatics
• Term: since 2025
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 562414918

The amount of medical literature, including overall prognosis studies, is exponentially increasing. Overall prognosis studies describe the course of a health status over time and can be summarised in systematic reviews to provide a more comprehensive estimate across various settings. While evaluation tools for the risk of bias and applicability of primary studies are available for other study types such as prognostic factor and prognostic model studies, no such tool has yet specifically been developed for overall prognosis studies. The current project aims to develop, pilot, implement and promote such a tool. Based on a preregistered protocol and a preliminary rough draft of potential signalling questions from existing tools and the results of a survey already conducted, a steering group consisting of experts in the field of prognosis, evidence synthesis and risk of bias will define the risk of bias for overall prognosis studies (RoB-OPS) tool. First, the scope and structure will be re-evaluated. Consecutively, discussion of each signalling question, description of the signalling question, and its response option will be iterated by the steering group until a satisfactory draft has been established and consented. Once the fine-tuned draft is completed, a consistency check by a small piloting round will be done which will also inform domain-based decision flow charts. Through a survey, the complete tool will undergo external evaluation by experts in the field. Survey results will be integrated by the applicant and discussed again by the steering group before undergoing external piloting by multiple author teams independent of the steering group to assess, on the one hand, the concepts of the tool, and on the other hand inter-rater reliability, user friendliness and understandability. The tool will be published in a peer-reviewed journal. The second part of the project is the implementation and promotion of the tool by developing additional resources such as an explanation and elaboration paper, a crib sheet, an MS Excel template, uptake in the relevant literature like the Cochrane Handbook on Prognosis Studies, distribution via workshops and linkage on relevant websites.

• DFG Programme: Research Grants