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Performance of the Standardised MedDRA® Queries for Case Retrieval in the French Spontaneous Reporting Database

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Abstract

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.

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Notes

  1. MedDRA® terminology is the international medical terminology developed under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). MedDRA® trademark is owned by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) on behalf of ICH.

  2. Since 1998, MedDRA® has been managed by the MSSO.

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Disclosures

No sources of funding were used to assist in the preparation of this study. Hélène Géniaux, Denise Assaf, Ghada Miremont-Salamé, Bénédicte Raspaud, Amandine Gouverneur, Philip Robinson, Antoine Pariente and Francesco Salvo have no conflicts of interest that are directly relevant to the content of this study.

Author information

Authors and Affiliations

  1. Université de Bordeaux, Bordeaux, France

    Hélène Géniaux, Denise Assaf, Bénédicte Raspaud, Amandine Gouverneur, Antoine Pariente & Francesco Salvo

  2. CHU de Bordeaux, Service de Pharmacologie, Bordeaux, France

    Hélène Géniaux, Ghada Miremont-Salamé, Bénédicte Raspaud, Amandine Gouverneur, Antoine Pariente & Francesco Salvo

  3. ADERA, Bordeaux, France

    Philip Robinson & Francesco Salvo

  4. CIC Bordeaux, CIC1401, Bordeaux, France

    Philip Robinson

  5. INSERM, U657, Bordeaux, France

    Ghada Miremont-Salamé & Antoine Pariente

  6. Centre de Pharmacovigilance, Hôpital Pellegrin, CHU, Place Amélie Raba Léon, 33076, Bordeaux Cedex, France

    Hélène Géniaux

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  1. Hélène Géniaux
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  2. Denise Assaf
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  3. Ghada Miremont-Salamé
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  4. Bénédicte Raspaud
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  8. Francesco Salvo
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Correspondence to Hélène Géniaux.

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Géniaux, H., Assaf, D., Miremont-Salamé, G. et al. Performance of the Standardised MedDRA® Queries for Case Retrieval in the French Spontaneous Reporting Database. Drug Saf 37, 537–542 (2014). https://doi.org/10.1007/s40264-014-0187-2

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  • DOI: https://doi.org/10.1007/s40264-014-0187-2

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