Standardised MedDRA Queries (SMQs) Part 1

What is Standardised MedDRA Queries (SMQs)?

Standardised MedDRA Queries (SMQs) are groupings of MedDRA terms, ordinarily at the Preferred Term (PT) level that relate to a defined medical condition or area of interest. SMQs are intended to aid in the identification and retrieval of potentially relevant individual case safety reports. The included terms may relate to signs, symptoms, diagnoses, syndromes, physical findings, laboratory and other physiologic test data, etc. The only Lowest Level Terms (LLTs) represented in an SMQ are those that link to a PT used in the SMQ; all others are excluded.

SMQs were developed to facilitate retrieval of MedDRA-coded data as a first step in investigating drug safety issues in pharmacovigilance and clinical development.

What is the Background?

SMQs arose out of a recognized need of the MedDRA user community for standard tools to assist in the identification and retrieval of safety data. The original MedDRA Special Search Categories (SSCs) were intended for a similar purpose, but after several years of MedDRA use, the biopharmaceutical community (regulators and industry) concluded that these tools did not adequately address the need. In response, the MedDRA Maintenance and Support Services Organization (MSSO), in early 2002, began to develop MedDRA Analytical Groupings (MAGs). MAGs were defined as collections of terms from any level of the MedDRA hierarchy (except, in general, LLTs) and from any, several, or all MedDRA SOCs that relate to the medical condition or area of interest defined by the name of the MAG, including signs, symptoms, physical findings, laboratory and other physiologic test data, and associated social circumstances related to the medical condition or area of interest.

At the same time that MAGs were being developed at the MSSO, an independent initiative by the Council for International Organizations of Medical Sciences (CIOMS) was started to address the need for special queries/groupings using MedDRA-coded data; their groupings were called Standardised Search Queries (SSQs). It was clear that the concepts of MAGs and SSQs were quite similar to one another and were both intended to fulfill the perceived need for a retrieval tool to accompany MedDRA. Thus, CIOMS and the MSSO agreed that it was in the user community’s best interest for the CIOMS Working Group and the MSSO to combine their efforts in developing this tool. To recognize the joint effort, the former “MAG” and “SSQ” designations were dropped, and an agreement on a name for these new standard groupings was reached. Since May 2003, the joint efforts of the CIOMS Working Group and MSSO have been designated Standardised MedDRA Queries (SMQs). In November 2003, the ICH MedDRA Management Board endorsed the cooperative effort, and the ICH process was adopted.

The CIOMS Working Group is composed of senior scientists from several drug regulatory authorities, international pharmaceutical companies, the MSSO, the Japanese Maintenance Organization (JMO), the World Health Organization, and other institutions.

Design Concepts for SMQs:

SMQs may have a mixture of very specific terms and less specific terms that are consistent with a description of the overall clinical syndrome associated with particular adverse event and drug exposure.

Narrow Scope SMQ’s:

Instances in which a user may need to identify cases that are highly likely to represent the condition of interest. It yields “specificity”.

Broad Scope SMQ’s:

Instances in which a user seeks to identify all possible cases, including some that may prove to be of little or no interest on closer inspection. It includes both narrow terms and additional broad terms, often of a less-specific in nature. It yields “sensitivity”.