The boundaries of biomedical result appraisal: mapping the gap between a result and its interpretation

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Abstract

Background Biomedicine has built competent tools for appraising results. Yet a finished, technically sound result is routinely reported and then used to support a broader claim, one that would need a comparison the study never made. Methods This is a conceptual analysis and coverage map of the major appraisal tools and validity concepts, including the risk-of-bias tools, causal diagrams, estimands, target-trial emulation, GRADE indirectness, transportability, clinical-applicability frameworks, outcome-reporting extensions, trial-trustworthiness checks and the classical validity tradition. Each is placed on four axes: whether it is used forwards or backwards, the level at which it works, its reference point, and its design scope. Five published trials were chosen purposively to show distinct ways a result and its interpretation come apart. Results The mapped tools cover estimate fidelity, causal identification, question specification, outcome anchoring, evidence transfer, clinical applicability, trustworthiness screening and the classical validity concerns. Their borders do not converge on one point: the finished result read against the specific interpretation now taken from it. There a result can be unbiased, identifiable, well specified, applicable to a fixed target, clinically appraisable and trustworthy as a report, and still be cited for a comparison it never made. PLCO, NordICC, Look AHEAD, CIRT and SPRINT trials come apart in five different ways: a contaminated comparator, an invitation most declined, a programme mistaken for its target, a pathway never engaged, and a measurement regime left behind. In every case the feature that fixes the contrast the study actually made was present in the published report, and unused. Conclusions Existing tools can appraise results in great detail. However, none of them routinely asks whether the interpretation now attached to the result is one its actual comparison can support. Construct, external and scope validity named this territory, but naming is not an operation. The check is simple: read what the study actually compared, then ask whether the interpretation now placed on it needs more than that. The gap is not in the evidence but in the reading of it.

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