title: [Validation of a measurement scale: example of a French Adverse Drug Reactions Preventability Scale].
abstract: Adverse drug reactions (ADRs) have been recognised as an important cause of hospital admission. Most of these drug-related admissions were expected ADRs and, thus, partly preventable. However, as far as we know, the assessment of the preventability of ADRs was addressed in only two studies performed in France. In contrast, several other studies have been performed, mainly in the USA, and using different methods of assessing preventability. None of these methods were clearly evaluated with regard to reproducibility, validity or relevance. The purpose of this study was to initiate the validation of a French preventability scale. Here, we propose the first two phases of validation: the content validity and reliability of the scale. A working group of pharmacovigilance experts has been specifically established for this purpose. The content validity was assessed by collecting items representative of preventability. The choice and the formulation of items and a proposal of a score (global and for each item) were adopted after the consensus of the experts. A definitive version of the ADR preventability scale was used for the assessment of reliability. During the second phase, experts independently tested the new scale from observations of ADRs (49 central nervous system haemorrhages with antivitamine K). The concordance of the experts' judgements was calculated using two statistical methods (Kappa statistic and correlation coefficient). The content validity phase was performed during several workshops where experts discussed the choice and formulation of the best items. We decided to construct a scale with a small number of items, allowing a rapid evaluation of the preventability of ADRs. On the basis of a global score, four categories of preventability of ADRs ("preventable", "potentially preventable", "unclassable", "not preventable" ADRs) were proposed. The agreement of experts regarding the global score was low, with a poor correlation coefficient value (coefficient interclass = 0.491). Classification of ADRs in the four categories by the experts showed discrepancies (Kappa = 0.1136). The preventability assessment using this scale was feasible, although poor concordance between the judges has raised some questions. Several experts found use of this scale difficult in terms of a clear understanding of the items, and found that two of them were redundant. We have oversimplified some items and revision of their formulation will be necessary. Moreover, most of ADR notifications were poorly documented, resulting in a frequent choice of an "unevaluable" item. This represented an important bias in the calculation of the global score. This experience suggests the need for further studies to improve this French ADR preventability scale and validate it in differing circumstances, in order to provide a useful tool to enhance the rational use of drugs.
authors.affiliation: Service de Pharmacologie Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'Informations sur le Medicament; Inserm U657, Faculté de Médecine, Toulouse, France. olivier@cict.fr
authors.forename: Pascale
authors.initials: P
authors.lastname: Olivier
authors.forename: Jacques
authors.initials: J
authors.lastname: Caron
authors.forename: Françoise
authors.initials: F
authors.lastname: Haramburu
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Imbs
authors.forename: Annie-Pierre
authors.initials: AP
authors.lastname: Jonville-Béra
authors.forename: Georges
authors.initials: G
authors.lastname: Lagier
authors.forename: Catherine
authors.initials: C
authors.lastname: Sgro
authors.forename: Thierry
authors.initials: T
authors.lastname: Vial
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Montastruc
authors.forename: Maryse
authors.initials: M
authors.lastname: Lapeyr-Mestre
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D064420:Drug-Related Side Effects and Adverse Reactions; D005602:France; D015203:Reproducibility of Results