XVI.Add.II.4.2. Checklist for harmonised reporting of study results

Established reporting standards such as the Strengthening the Reporting of Observational studies in Epidemiology (STROBE) Statement12 may have limited effects on the reporting quality of studies evaluating RMM effectiveness (while being appropriate for other purposes). This is because these standards focus on single study designs without addressing the underlying rationale and critical factors relevant to the implementation of health interventions such as RMM in healthcare contexts. The recent Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE) 13 , tailored to study designs frequently used for RMM evaluation (42), should be used to standardise reporting of the results of such studies. Reporting items have been derived from the RIMES-SE standard for reporting results of RMM effectiveness studies (see Table XVI.App.II.1., RIMES-SE items are marked by #), to facilitate the completion of the final report in the format described in GVP Module VIII.