Spontaneous Signalling Arguments

Report Phase Signalling (Signal Detection)

Versus Case Phase Signalling (Signal Evaluation)

It is useful to classify spontaneous signalling methods around several broad functional steps that comprise signalling arguments, namely sorting, identification, case series formation and case series characterization (see Figure 19.1 and Table 19.2). The first two steps (sorting and identification) are based on reports, while the second two (case series formation and characterization) are based on only those reports that meet a case definition. The report-based steps and case-based steps are sometimes referred to as the signal detection and signal evaluation phases, respectively. Report phase followed by case phase signalling programs probably evolved from the basic attributes of spontaneous surveillance: (1) the large number of different product-AE pairs that are reported for any given product; (2) the relatively small number of product-AE pairs that are found to be important from a surveillance perspective; and (3) the need to carefully examine spontaneous report data prior to the initiation of

Table 19.2. Classification of spontaneous report signalling methods by functional step and data strategy.

Data strategies

Quantitative

Functional Qualitative -

steps intra-product Intra-product Inter-product

Sorting

Qualitative sorting methods

Quantitative sorting methods

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