Abstract
{ "background": "District hospitals in Ghana face systemic challenges in patient safety and operational risk management. While randomised field trials (RFTs) are considered a gold standard for evaluating interventions, their methodological application in this complex, resource-constrained setting requires critical assessment to ensure validity and generalisability of findings.", "purpose and objectives": "This review critically evaluates the methodological rigour of RFTs designed to measure risk reduction in Ghanaian district hospital systems. It aims to appraise trial design, implementation challenges, and the robustness of outcome measurement, providing a framework for future research.", "methodology": "A systematic search identified RFTs of quality improvement or safety interventions. Methodological quality was assessed using a bespoke framework evaluating randomisation, blinding, outcome measurement, and analytical approach. The primary analysis employed a mixed-effects model to assess heterogeneity in effect sizes: $Y{ij} = \\beta0 + \\beta1 X{ij} + uj + \\epsilon{ij}$, where $u_j$ represents the random effect for study $j$.", "findings": "Methodological quality was highly variable. A predominant theme was the frequent compromise of allocation concealment and blinding, leading to potential performance bias. Notably, trials implementing structured team-based protocols demonstrated a significant pooled reduction in medication error rates (odds ratio 0.65, 95% CI 0.52 to 0.81), though with considerable heterogeneity (I² = 68%).", "conclusion": "RFTs can generate valuable evidence for risk reduction, but common methodological shortcomings in their African application may inflate perceived effect sizes and limit transferability. Rigorous adaptation to contextual constraints is essential.", "recommendations": "Future RFT protocols must prioritise pragmatic designs with robust randomisation and blinded outcome assessment. Investment in local research capacity for trial management and data analysis is critical. Funders should mandate published protocols and statistical analysis plans.", "key words": "randomised controlled trial, patient safety, health systems research