Construct and concurrent validity of a patient-reported adverse drug event questionnaire: a cross-sectional study
Abstract
BACKGROUND: Direct patient-reported information about adverse drug events (ADEs) is important since it adds to healthcare professional-reported information about the safety of drugs. Previously, we developed an instrument to assess patient-reported ADEs in research settings. The aim of this study is to assess the construct and concurrent validity of the questionnaire.
METHODS: Patients on at least an oral glucose-lowering drug completed the ADE questionnaire, the World Health Organization Quality of Life-BREF, and the Treatment Satisfaction Questionnaire for Medication (TSQM). The ADE questionnaire assesses ADEs for any drug that the patient uses. Construct validity was assessed by testing whether patients reporting an ADE had a lower general quality of life and physical health than those not reporting an ADE, using Mann-Whitney U-tests and t-tests (significance level <0.05). For concurrent validity, we tested whether ADEs that patients associate with particular drugs in the ADE questionnaire are documented in the Summary of Product Characteristics (SPC) of those drugs, and whether patients who report an ADE with the use of metformin on the TSQM, mention metformin as a drug associated with an ADE on the ADE questionnaire. Agreement of 70% with the SPC was considered satisfactory. Sensitivity and positive predictive value (PPV) were calculated for the comparison with the TSQM, where 70% was used as the cut-off level for sufficient concurrent validity.
RESULTS: We included 135…
How strong is the evidence?
Evidence Hub reads this as a cross-sectional, done in people. Its evidence level is 4 of 5 (Low · observational). Observational designs can show an association but not prove cause. Reported size: 135 participants or records.
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