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Table 2.4 Fundamental Prerequisites and Assessment Criteria of the Cause-Effect
Relationship ( Continued )
Major (to be evaluated individually)
•Temporality (“cart behind the horse”)
Strength (relative risk, odds ratio, hazard ratio)
• Specificity (exclusivity or predominance of an observation and its effect)
Manifestational (“unique” pattern of clinical spectrum and gradient as a
presumed consequence of exposure)
Causal (etiological fraction, preventable fraction, protective or curative effect,
attributable risk, risk difference, attributable risk percent, attributable hazard,
proportional hazard)
Biological gradient (more exposure = stronger association)
Consistency (assessment of homogeneity of findings across studies, settings, time,
place, and people)
Biological plausibility (explanation of underlying mechanisms or nature of
Conditional (not always necessary for new discoveries)
Coherence with prevalent knowledge
Reference (within the framework of the scientific method)
Experimental proof (preventability, curability): Clinical trials, other kinds of
controlled experiments, or “cessation studies”
Conirmation (providing a clear problem definition, research question, relevant
dependent and independent variables, and target population)
Systematic review and meta-analysis of evidence
Criteria for the causal reasoning process and demonstration of causality as a whole:
Interpretation of the brought up causal proof
Possible role in argumentation: Conclusions, claim stemming for an argument, claim,
1. A single criterion is not used as a sole proof of causality
2. Each and every criterion of causality was a subject of evaluation and
interpretation by a fallacy-free confirmation or refutation
3. Completeness and validity of the criteria fulfilled were assessed
Source : Modified and redrawn from Jenicek, M., Epidemiology. The Logic of Modern
Medicine , EPIMED International, Montréal, 1995; Jenicek, M., Foundations of
Evidence-Based Medicine , The Parthenon Publishing Group/CRC Press, Boca
Raton/London/New York/Washington, 2003.
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