Beyond randomisation: Re-thinking evidence hierarchies in global surgery

Abstract

The rise of evidence-based medicine positioned randomised controlled trials (RCTs) at the pinnacle of evidence hierarchies, profoundly shaping how surgical research is evaluated. While the increasing conduct of large surgical RCTs marks important progress, an exclusive reliance on randomisation risks marginalising forms of evidence that are central to global surgery. In low- and middle-income countries, surgical advances frequently arise from frugal surgical innovations that are locally developed, contextually relevant, and evaluated predominantly through observational and qualitative research. Privileging RCTs as the sole marker of scientific legitimacy perpetuates epistemic inequities and overlooks the realities of surgical practice in resource-constrained settings. This paper argues for methodological pluralism, recognising the legitimate and complementary roles of observational and qualitative studies within established frameworks such as IDEAL. A more inclusive evidence paradigm is essential to ensure relevance, equity, and impact in global surgery.