Comparative Evidence on Harms in Pediatric RCTs from Less Developed versus More Developed Countries Is Limited

Publication date: Available online 28 November 2017
Source:Journal of Clinical Epidemiology
Author(s): Dario Tedesco, Mufiza Farid-Kapadia, Martin Offringa, Zulfiqar A. Bhutta, Yvonne Maldonado, John P.A. Ioannidis, Despina G. Contopoulos-Ioannidis
ObjectiveEvaluate comparative harm-rates from medical interventions in pediatric randomized-trials (RCTs) from more-developed (MDCs) and less-developed countries (LDCs).Study DesignMeta-epidemiologic empirical evaluation of Cochrane Database of Systematic Reviews (June 2014) meta-analyses reporting clinically-important harm-outcomes (severe adverse events [AEs], discontinuations due to AEs, any AE and mortality) that included at least 1 pediatric-RCT from MDCs and at least 1 from LDCs. We estimated relative-odds-ratios (ROR) for each harm, within each meta-analysis, between RCTs from MDCs and LDCs and calculated random-effects-summary-RORs (sROR) for each harm across multiple meta-analyses.ResultsOnly 1% (26/2363) of meta-analyses with clinically-important harm-outcomes in the entire Cochrane Database of Systematic Reviews included pediatric-RCTs both from MDCs and LDCs. We analyzed 26 meta-analyses with 244 datasets from pediatric-RCTs, 116 from MDCs and 128 from LDCs (64 and 66 unique RCTs respectively). The sROR was 0.92 (95% CIs: 0.78-1.08) for severe-AEs; 1.13 (0.54-2.34) for discontinuations due to AEs; 1.10 (0.77-1.59) for any-AE; and 0.99 (0.61-1.61) for mortality and for the all-harms-combined-endpoint 0.96 (0.83-1.10). Differences of ROR-point-estimates ≥2-fold between MDCs and LDCs were identified in 35% of meta-analyses.ConclusionWe found no major systematic differences in harm rates in pediatric trials between MDCs and LDCs, but data on harms in children were overall very limited.



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