Table 2 VICORT criteria definition and relation to other epidemiological concepts
VICORT Criteria | Definition | Related criteria from literature synthesis | Relation to other epidemiological frameworks or concepts |
|---|---|---|---|
Validity | Methods are appropriate for internal validity of results: ∙ Experimental evidence generated is not subject to randomization, blinding, protocol deviation, missing data, or measurement issues. ∙ Observational evidence generated is not subject to confounding, information, and endogenous selection biases. | Confounding Consistency of results Dose-response gradient Precision Reporting bias Risk of bias Strength and level of evidence | Quality assessment tools, e.g., - Cochrane risk-of-bias tool [7] - Risk of bias in non-randomised Studies of Interventions) [6] - Newcastle-Ottawa Scale [58] |
Indication-informativeness | Study methods provide clinicians with evidence to determine a clinical indication in specific individuals. Informativeness for a clinical indication requires a well-defined intervention whose effect can be identified from the study results, i.e.: 1. A trial of an intervention (experimental study) in specific/eligible individuals; OR 2. An observational study of an exposure where: A) A well-defined intervention for specific individuals (those with the exposure) exists, AND B) That the effect of this well-defined intervention be correctly identified (independent effect of the intervention); OR 3. An observational study where there is an intervention on specific individuals and where absolute results for outcomes are explicitly reported. (informativeness for the outcome of an intervention criterion – allows contrast between intervention in specific individuals and envisioned natural history under no intervention in those individuals). | None | Well-defined intervention, consistency assumption of causal inference [26, 61] |
Clinical relevance | Primary outcome of the study is clinically relevant, i.e., the outcome is at a minimum clinically informative, and ideally, patient centered. | Directness Relevance of outcomes | Surrogate outcomes [62] Overdiagnosis [63] Patient-centered outcomes research [13] |
Originality | Significance. Study results achieve clinical (not only statistical) significance (e.g., a relevant magnitude of effect); AND Novelty. Study results are novel when compared to current evidence base and practice. | Comparison intervention Intervention characteristics Magnitude (effect size) and trade-offs of harms and benefits | Clinical vs sole statistical significance Dichotomization vs magnitude of effect and confidence intervals [64, 65] |
Risk-benefit comprehensiveness | Overall benefits of changing an indication (either the intervention or the population of individuals in which the intervention is indicated) comprehensively outweigh the risks. | Magnitude and trade-offs of harms and benefits | Net benefit - Generic health state measures |
Transposability | The clinical indication/intervention is implementable and (cost-) effective in the specific practice setting. | Acceptability and feasibility Context and resources for application Cost and cost-effectiveness Equity and ethics Monitoring/audit and support tools Representativeness of patients and populations Scope of practice and actions Sustainability Values, beliefs, preferences priority | Generalizability and transportability [14, 22, 64] Cost-effectiveness analysis [21] |