Single case alert SMQs may be used to create a (e.g., an automated notification system) to alert “watch list” the user of incoming cases needing urgent review. Example Single Case Alert A medical issue of interest needs to be communicated to a regulatory authority as part of an agreed risk management plan. The SMQ narrow search or more specific levels of a hierarchical SMQ may be applied to identify potential cases of interest. Periodic reporting SMQs may help aggregate relevant cases for ongoing review of specific safety issues in periodic safety reports. SMQs may also be used for other routine reviews of aggregate data (e.g., reports of lack of efficacy) in the context of a periodic report. SMQ Search Options Some SMQs have options that may be used to refine a particular search. The most common option is use of narrow and broad search terms. By definition, a broad search includes both narrow and broad terms. Some SMQs are hierarchical (i.e., contain one or more sub-searches). Other SMQs use algorithms, and in one case (SMQ Systemic lupus erythematosus), weightings are assigned to particular terms for signs, symptoms and laboratory results to help identify cases. Narrow and broad searches Most SMQs have narrow and broad PTs. The narrow PTs have a greater likelihood of identifying only events of interest (high specificity) while the broad terms are intended to identify additional possible events (high sensitivity). Some events retrieved by the broad search terms may, upon further review, not relate to the condition of interest. The user can select the scope of the search (narrow or broad) that is most applicable to the question being asked. Figure 12 is an example of output of narrow and broad searches. When a compound is in early phase development or has only recently been marketed, it may be advisable to use the broad search. Example Use of Broad Search If evaluating an emerging signal of lactic acidosis using SMQ Lactic acidosis, narrow terms may be applied to identify events where the specific diagnosis has been reported; however, events of reported signs and symptoms would not be retrieved. If there is additional need to find cases where no specific diagnosis (but mainly signs and symptoms) have been reported, then a broad search (i.e., narrow + broad search terms) should be applied.
Single case alert SMQs may be used to create a “watch list” (e.g., an automated notification system) to alert the user of incoming cases needing urgent review. Example Single Case Alert A medical issue of interest needs to be communicated to a regulatory authority as part of an agreed risk management plan. The SMQ narrow search or more specific levels of a hierarchical SMQ may be applied to identify potential cases of interest. Periodic reporting SMQs may help aggregate relevant cases for ongoing review of specific safety issues in periodic safety reports. SMQs may also be used for other routine reviews of aggregate data (e.g., reports of lack of efficacy) in the context of a periodic report. SMQ Search Options Some SMQs have options that may be used to refine a particular search. The most common option is use of narrow and broad search terms. By definition, a broad search includes both narrow and broad terms. Some SMQs are hierarchical (i.e., contain one or more sub-searches). Other SMQs use algorithms, and in one case (SMQ Systemic lupus erythematosus), weightings are assigned to particular terms for signs, symptoms and laboratory results to help identify cases. Narrow and broad searches Most SMQs have narrow and broad PTs. The narrow PTs have a greater likelihood of identifying only events of interest (high specificity) while the broad terms are intended to identify additional possible events (high sensitivity). Some events retrieved by the broad search terms may, upon further review, not relate to the condition of interest. The user can select the scope of the search (narrow or broad) that is most applicable to the question being asked. Figure 12 is an example of output of narrow and broad searches. When a compound is in early phase development or has only recently been marketed, it may be advisable to use the broad search. Example Use of Broad Search If evaluating an emerging signal of lactic acidosis using SMQ Lactic acidosis, narrow terms may be applied to identify events where the specific diagnosis has been reported; however, events of reported signs and symptoms would not be retrieved. If there is additional need to find cases where no specific diagnosis (but mainly signs and symptoms) have been reported, then a broad search (i.e., narrow + broad search terms) should be applied.