Digital tools in the informed consent process: a systematic review

Abstract Background Providing understandable information to patients is necessary achieve the aims of Informed Consent process: respecting and promoting patients’ autonomy protecting from harm. In recent decades, new, primarily digital technologies have been used apply test innovative formats Consent. We conducted a systematic review explore impact using tools for in both clinical research practice. Understanding, satisfaction participation were compared versus non-digital process. Methods searched studies on available electronic databases, including Pubmed, EMBASE, Cochrane. Studies identified specific Mesh-terms/keywords. included studies, published January 2012 October 2020, that focused use research, or procedures. Digital interventions defined as multimedia audio–video provide patients. classified into 3 different categories: video only, non-interactive multimedia, interactive multimedia. Results Our search yielded 19,579 publications. After title abstract screening 100 retained full-text analysis, which 73 publications included. examined (29/73), (13/73), videos (31/73), most (34/38) adults. Innovations consent tested clinical/surgical procedures (26/38) (12/38). For IC, 21 outcomes explored, with positive effect at least one studied being observed 8/12 studies. 49 21/26 reported outcomes. Conclusions informed not found negatively affect any outcomes, overall, seem desirable. Multimedia indicated higher than only. Presence researcher may potentially enhance efficacy IC processes. heterogeneous design, making evaluation challenging. Robust study design standardization needed conclusively assess impact.