Is artificial intelligence for medical professionals serving the patients? Protocol for a mixed method systematic review on patient-relevant benefits and harms of algorithmic decision-making.

Background: Algorithmic decision making (ADM) utilizes algorithms to collect and process data and develop models to make or support decisions. Advances in artificial intelligence (AI) have led to the development of support systems that can be superior to medical professionals without AI support in certain tasks. However, whether patients can benefit from this remains unclear. The aim of this systematic review is to assess the current evidence on patient-relevant benefits and harms when healthcare professionals use ADM systems (developed using or working with AI) compared to healthcare professionals without AI-related ADM (standard care) - regardless of the clinical issues. Furthermore, for interpreting collected evidence and analysing preconditions for the implementation of AI-related ADM in healthcare, experts from research, practice, and regulation will be interviewed. Methods Following the PRISMA statement and the MECIR standards for reporting systematic reviews, MEDLINE and PubMed (via PubMed), EMBASE (via Elsevier), IEEE Xplore, CENTRAL will be searched using English free text terms in title/abstract, Medical Subject Headings (MeSH) terms and Embase Subject Headings (Emtree) fields. Additional studies will be identified by contacting authors of included studies and through reference lists of included studies. Grey literature searches will be conducted in Google Scholar. Risk of bias will be assessed by using Cochranes RoB 2 for randomised trials and ROBINS-I for non-randomised trials. Transparent reporting of the included studies will be assessed using the CONSORT-AI extension statement. Following the SRQR statement, semi-structured interviews will be conducted and analysed with the help of a qualitative content analysis according to Mayring. Based on the research questions and the findings of the systematic review, the study and interview guide will be developed a priori. Discussion It is expected that there will be a substantial shortage of suitable studies that compare healthcare professionals with and without ADM systems concerning patient-relevant endpoints. This can be attributed to the prioritization of technical quality criteria and, in some cases, clinical parameters over patient-relevant endpoints in the development of study designs. Furthermore, it is anticipated that a significant portion of the identified studies will exhibit relatively poor methodological quality and provide only limited generalizable results.