OBJECTIVE: The objective of this study was to evaluate the performance of Standardised MedDRA® Queries (SMQs) in adverse drug reaction (ADR) identification. METHODS: ADR cases included in the last complete year of the French Pharmacovigilance database for research were used to test four SMQs (narrow and broad): agranulocytosis, demyelination, osteonecrosis and psychosis. Reference cases were identified by free-text search and validated by two authors. Sensitivity (Se), specificity (Sp), positive predictive value (PPV) and negative predictive value (NPV) of narrow and broad searches of each SMQ were calculated and reported as proportions with 95% exact confidence interval (CI). RESULTS: Among 20,830 cases reported in 2009, 337 validated cases of agranulocytosis, 17 of demyelination, 52 of osteonecrosis and 230 of psychosis were included in the reference sets. Estimations of SMQ narrow search performance were as follows: Se 62.9% (95% CI 57.5-68.1) and PPV 46.8% (95% CI 42.1-51.5) for agranulocytosis; Se 88.2% (95% CI 63.6-98.5) and PPV 34.1% (95% CI 20.5-49.9) for demyelination; Se 94.2% (95% CI 84.1-98.8) and PPV 74.2% (95% CI 62.0-84.2) for osteonecrosis; and Se 75.1% (95% CI 69.0-80.6) and PPV 87.8% (95% CI 82.3-92.0) for psychosis. Results obtained using the broad search were similar except for PPV concerning osteonecrosis (52.7% [95% CI 42.1-63.1]) and psychosis (61.4% [95% CI 55.7-66.8]). For all selected SMQs, Sp and NPV were greater than 98% for both narrow and broad searches. CONCLUSION: Heterogeneous performance of SMQs for case retrieval was found and seems to be related to the characteristics of the condition of interest. It could therefore be expected that for other SMQs, performance may be affected in the same manner.
OBJECTIVE: The objective of this study was to evaluate the performance of Standardised MedDRA® Queries (SMQs) in adverse drug reaction (ADR) identification. METHODS: ADR cases included in the last complete year of the French Pharmacovigilance database for research were used to test four SMQs (narrow and broad): agranulocytosis, demyelination, osteonecrosis and psychosis. Reference cases were identified by free-text search and validated by two authors. Sensitivity (Se), specificity (Sp), positive predictive value (PPV) and negative predictive value (NPV) of narrow and broad searches of each SMQ were calculated and reported as proportions with 95% exact confidence interval (CI). RESULTS: Among 20,830 cases reported in 2009, 337 validated cases of agranulocytosis, 17 of demyelination, 52 of osteonecrosis and 230 of psychosis were included in the reference sets. Estimations of SMQ narrow search performance were as follows: Se 62.9% (95% CI 57.5-68.1) and PPV 46.8% (95% CI 42.1-51.5) for agranulocytosis; Se 88.2% (95% CI 63.6-98.5) and PPV 34.1% (95% CI 20.5-49.9) for demyelination; Se 94.2% (95% CI 84.1-98.8) and PPV 74.2% (95% CI 62.0-84.2) for osteonecrosis; and Se 75.1% (95% CI 69.0-80.6) and PPV 87.8% (95% CI 82.3-92.0) for psychosis. Results obtained using the broad search were similar except for PPV concerning osteonecrosis (52.7% [95% CI 42.1-63.1]) and psychosis (61.4% [95% CI 55.7-66.8]). For all selected SMQs, Sp and NPV were greater than 98% for both narrow and broad searches. CONCLUSION: Heterogeneous performance of SMQs for case retrieval was found and seems to be related to the characteristics of the condition of interest. It could therefore be expected that for other SMQs, performance may be affected in the same manner.
Authors: Eugène P van Puijenbroek; Andrew Bate; Hubert G M Leufkens; Marie Lindquist; Roland Orre; Antoine C G Egberts Journal: Pharmacoepidemiol Drug Saf Date: 2002 Jan-Feb Impact factor: 2.890
Authors: Marie Dupuch; Magnus Lerch; Anne Jamet; Marie-Christine Jaulent; Reinhard Fescharek; Natalia Grabar Journal: Stud Health Technol Inform Date: 2011
Authors: Ronald K Pearson; Manfred Hauben; David I Goldsmith; A Lawrence Gould; David Madigan; Donald J O'Hara; Stephanie J Reisinger; Alan M Hochberg Journal: Int J Med Inform Date: 2009-02-18 Impact factor: 4.046
Authors: Mickael Arnaud; Francesco Salvo; Ismaïl Ahmed; Philip Robinson; Nicholas Moore; Bernard Bégaud; Pascale Tubert-Bitter; Antoine Pariente Journal: Drug Saf Date: 2016-03 Impact factor: 5.606
Authors: Arthur Wasylewicz; Britt van de Burgt; Aniek Weterings; Naomi Jessurun; Erik Korsten; Toine Egberts; Arthur Bouwman; Marieke Kerskes; René Grouls; Carolien van der Linden Journal: Br J Clin Pharmacol Date: 2021-10-13 Impact factor: 3.716
Authors: Wajd Alkabbani; Ryan Pelletier; Michael A Beazely; Youssef Labib; Breanna Quan; John-Michael Gamble Journal: Drug Saf Date: 2022-03-05 Impact factor: 5.228