Standardised MedDRA Queries (SMQs) are used to support signal detection and monitoring. SMQs are validated, standard sets of MedDRA terms. These sets of terms have undergone extensive review, testing, analysis and expert discussion by a working group of MedDRA and product safety experts. SMQs represent a variety of safety topics of regulatory interest (e.g., SMQ Severe cutaneous adverse reactions, SMQ Anaphylactic reaction).
Some SMQs are a simple set of PTs while other SMQs are hierarchical containing subordinate SMQs. SMQs include narrow and/or broad terms. Narrow terms are those that are highly likely to represent the condition of interest. For example, the PTs Pancreatitis acute and Pancreatitis haemorrhagic are narrow terms for the SMQ Acute pancreatitis whereas PT Blood bilirubin increased is a broad term because not all instances of increased blood bilirubin are indicative of acute pancreatitis. Users may wish to retrieve MedDRA-coded data using only an SMQ's narrow terms if desired. A few SMQs are algorithmic, i.e., case identification may be improved when more than one MedDRA PT in the SMQ is represented in a single case.
Example of a simple SMQ of narrow and broad terms:
- Lactic acidosis is a form of high anion gap metabolic acidosis
- Intrinsic cardiac contractility may be depressed, but inotropic function can be normal because of catecholamine release
- Peripheral arterial vasodilatation and central vasoconstriction can be present
- Central nervous system function is depressed, with headache, lethargy, stupor, and, in some cases, even coma
- Glucose intolerance may occur
- Characterised by an increase in plasma L-lactate
- Acidosis is seldom significant unless blood lactate exceeds 5 mmol/l
- Clinical presentation in type B lactic acidosis:
- Symptoms : hyperventilation or dyspnea, stupor or coma, vomiting, drowsiness, and abdominal pain
- Onset of symptoms and signs is usually rapid, accompanied by deterioration in the level of consciousness
- Braunwald E, Fauci A, Kasper D. Harrison’s Principles of Internal Medicine. 15th Edition, 2001 pp 285-9
- Weatherall D, Ledingham J and Warrell D. Oxford Textbook of Medicine. Third edition, 1996; volume 2 pp 1541-44