Evaluating the Impact of Malaria Rapid Diagnostic Tests (mRDTs) on Patient-Important Outcomes in Sub-Saharan Africa: A Systematic Review Protocol

Background: Access to rapid diagnostic tests for malaria (mRDTs) has significantly increased in sub-Saharan Africa, but this region still bears the largest burden of Malaria. Assessing the impact of mRDTs on patient-important outcomes is essential in effectively guiding their future evaluation and programmatic scale-up.Objective: We aim to critically assess the study designs, outcome measures, methodological quality and implementation challenges of studies that evaluate the impact of mRDTs compared to other malaria diagnostic tests on patient-important outcomes among persons suspected of malaria in sub-Sahara Africa through a systematic review of the literature.Methods and Analysis: We will search MEDLINE, EMBASE, Cochrane Library, African Index Medicus and clinical trial registries from inception until June 2022. We will include a primary randomized or non-randomized study that compares the impact of mRDTs to clinical diagnosis, microscopy and polymerase chain reaction (PCR) on patient-important outcomes such as time to diagnosis/turn-around time, time to initiation of therapy, time to resolution of malaria-associated symptoms, morbidity and mortality in both adults and children. We will also include quantitative studies with an additional qualitative component (mixed methods studies) to assess the implementation challenges of mRDTs. We will assess the methodological quality of included studies using National Institutes of Health (NIH) quality assessment tools for experimental and observational studies. We will use the Mixed methods appraisal tool (MMAT) version 2018 for mixed methods studies. We will analyse our results through descriptive statistics and thematic content analysis and present our findings narratively, graphically and by quality ratings.Registration: This protocol is registered with the International Prospective Register of Systematic Reviews (PROSPERO), registration number CRD42018083816.Dissemination: We intend to publish the outcome of our review in a peer-reviewed journal and develop a valuable and accessible result summary.