Impact of Using Biomarkers in Eligibility Criteria in Acute Kidney Injury Randomized Controlled Trials: A Systematic Review and Methodological Meta-Analysis

ABSTRACTRationale 0.06-0.17). In the control and interventional groups, the absolute risk differences were 0.10 (95%CI 0.01-0.19) and 0.12 (95%CI; 0.06-0.18) respectively. For kidney damage biomarkers, the risk difference was 0.13 (95% CI; 0.06-0.20). The mean pre-planned and achieved statistical powers were 0.84 (±0.07) and 0.43 (±0.28), respectively, with no improvement when extrapolating the pre-planned sample size. Limitations Most RCTs were underpowered for their primary outcome. There was a high level of heterogeneity. Conclusions There is a difference between expected and observed incidence rates that may be partly attributed to biomarker-based enrichment methods. These findings highlight the need for rigorous validation of biomarkers before their incorporation into the eligibility criteria of RCTs.