Harms reporting assessment regarding systematic reviews focusing on direct oral factor Xa inhibitors: a cross-sectional study

Our primary objective is to evaluate the quality and completeness of harms reporting in systematic reviews (SRs) regarding factor Xa inhibitors through a cross-sectional analysis. We searched MEDLINE (PubMed and OVID), EMBASE, Epistemonikos, and Cochrane Database Systematic Reviews for SRs comprised of randomized control trials (RCTs) designed to evaluate direct oral factor Xa inhibitors. We performed screening and data extraction for harms among eligible SRs in a masked, duplicate fashion using a pilot-tested Google Form. This form, based on the published work of Qureshi and colleagues, quantified the reporting of harms among SRs. AMSTAR-2 was used to evaluate the methodological quality of the included SRs. Corrected covered area (CCA) was calculated for overlap of primary studies between SR dyads. Approximately 70 SRs comprising 242 unique primary studies met inclusion criteria and were included in the present study for analysis. Of these 70 SRs, 69 (69/70, 98.6%) reported harms as a primary outcome. Further, 23 SRs (23/70, 32.9%) completed 50% or less of harms items. Seven (7/70, 10%) SRs reported the total number of patient treatment discontinuations. Less than half of SRs (38/70, 54.3%) established severity scales to evaluate harms. CCA data showed 12 studies containing 50% or higher CCA values and many contained less than 50% overlap for harms. No statistically significant associations were found. We found the overall reporting of harms to be incomplete. Because SRs are often viewed for clinical practice, improvements must be made to better report harms.