Bringing Regulatory-Style Benefit-Risk Assessment to the Bedside: A Structured Evidence Synthesis Methodology for Shared Decision-Making.

BACKGROUND: Drug regulatory agencies now evaluate treatments by weighing benefits against harms in a structured, transparent process, yet the summaries that reach clinicians at the point of care still fragment efficacy and safety into separate statistics that hide absolute effects, mask how results vary across patients, and omit individual preferences. OBJECTIVE: To propose a structured evidence synthesis method that translates benefit-risk evaluation logic into a traceable, clinician-facing summary for shared decision-making. METHODS: Drawing on established benefit-risk methods (BRAT, MCDA), value-based healthcare principles, and clinical decision science, we describe a seven-domain value structure, a workflow centred on an effects table that presents benefits and harms as absolute effects per 1000 patients, and two summary metrics (Net Clinical Benefit, NCB, and Trade-off Index, TIX) computed using simple arithmetic. RESULTS: We present the proposed framework, compare it with existing approaches, and outline a staged development pathway, standardisation, pilot testing, and prospective evaluation, required to establish feasibility, reproducibility, and impact on decision quality. CONCLUSION: The methodology bridges benefit-risk evaluation and clinical conversations by making multi-outcome trade-offs explicit and testable under varying assumptions. In practice, the underlying evidence synthesis is performed within guideline or review processes, while clinicians use the resulting summary to structure bedside discussions and incorporate patient priorities. Whether this approach improves alignment between treatment choices and patient values is an empirical question this concept paper poses but does not answer.