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Objectives To determine the barriers and facilitators to using real world data (RWD) in healthcare settings in low-and middle-income countries (LMICs). Method We conducted a systematic review through searching MEDLINE, EMBASE, Global Health Database and CINAHL. We searched for qualitative studies that address the use of RWD, barriers and facilitators, and its applications in LMICs. Study participants included healthcare settings/organizations in LMICs which collect and use RWD. Primary outcomes are the roles of using RWD, and barriers/facilitators affecting the applications of RWD in healthcare settings in LMICs. Data extraction included contextual and methodological data. Quality of review will be assessed using the CASP Qualitative checklist, and we will follow the ENTREQ checklist for synthesis of qualitative research. Risk of bias will be assessed using GRADE-CERQual to determine the level of confidence from qualitative evidence synthesis. Qualitative data synthesis will be done as narrative/ descriptive synthesis of the roles of using RWD in healthcare settings in LMICs; thematic synthesis and conceptual framework of the barriers/facilitators of using RWD and its applications. Results The review addressed the use of real-world data in healthcare settings in LMICs, according to World Bank classification including 137 countries as per World Bank country classification. Initial search across the four databases showed a total of 2,245 search results. The results were separated into three sets; systematic reviews (n = 27) from 2012 until 2018; primary studies (n = 2,048) from 1988 until 2019; and conference abstracts (n = 170) from 2004 until 2018. Preliminary searches are completed, and piloting of the study selection process was done. Formal screening of results against eligibility criteria is underway and will be presented in conference. Conclusions The use of RWD in healthcare settings in LMICs is important to make evidence-based improvements in care delivery and health outcomes. Results from this systematic review will address the gap in evidence about what real world data is used in LMICs and the barriers and facilitators to its use. This review will generate qualitative evidence about the roles, barriers and facilitators and real-world applications of using RWD in healthcare settings in LMICs.

results section, we split up descriptive information from primary studies (sex rates) and analytic approaches (considering sex/gender in the assessment of risk of bias, presenting disaggregated data by sex/gender or subgroup or heterogeneity analyses). We used 'not applicable' to denote a situation where insufficient primary studies or data on estimates did not enable to conduct the intended analyses (e.g. meta-analysis, subgroup analysis). We performed descriptive statistics and regression analyses to assess associations between authors' gender and sex/gender reporting. Results 556 reviews were screened, of which 91 were excluded due to withdrawal (19,8%) or sex-specific disease (80,2%). Our analysis comprised 465 studies, including 2 prognosis, 4 methodology, 5 overview, 20 diagnostic and 421 intervention reviews. Women represented 53,8% (n = 250) and 38,9% (n = 181) of first and last authorship, respectively, while in 25,3% of reviews both authors were women. 85,6% of authors belonged to high-income countries. 7.5% (n = 35) of reviews reported on sex in the abstract, 17.6% (n = 82) in the methods and 61.4% (n = 285) in the results section. Of these 285, 64.7% provided descriptive results and 16,3% had an analytic approach. In the discussion section, 13.5% (n = 63) of reviews addresses sex-related findings. Only 4 studies scored positive in all 4 sections. Studies with female firstlast authorship had a non-significant increased probability of reporting on sex (RR [95% CI] 1,24 [0.68-1.92]) Conclusions Consideration of sex and gender in Cochrane reviews is scarce. This prevents from generating inclusive and unbiased health research and inhibits effective population-wide translation of results. While women are less likely to be last authors, studies with a female first or last author show an increased (although non-significant) probability of reporting on sex.

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