Validation of a specific measure to assess health-related quality of life in patients with schizophrenia and bipolar disorder: the 'Tolerability and quality of life' (TOOL) questionnaire

Background: Perception of quality of life may differ depending on the perspective. The aim of the study was to assess the psychometric properties of the Spanish version of the 'TOlerability and quality Of Life' (TOOL) questionnaire, a specific self-rated instrument to evaluate the impact of side effects of antipsychotic drugs on health-related quality of life (HRQoL). The questionnaire consists of eight items answered on a four-point Likert scale. Methods: A psychometric study was conducted with clinically stable outpatients with schizophrenia and bipolar disorder under antipsychotic treatment. The translation and cultural adaptation of the questionnaire was performed according to international standards. Internal consistency using the Cronbach a coefficient and test-retest reliability using the intraclass correlation coefficient (ICC) was used to assess the reliability of the instrument. Patients completed generic and specific measures of quality of life and clinical severity. Results: A total of 238 patients were analysed, with a mean age of 42 years (SD 10.9). The mean completion time was 4.9 min (SD 4.4). Internal consistency and intraclass correlation coefficient were adequate (Cronbach alpha = 0.757 and ICC = 0.90). Factorial analysis showed a unidimensional structure (a single eigenvalue > 1, accounting for 39.1% of variance). Significant Spearman's rank correlations between the TOOL and both generic and specific measures were found. The questionnaire was able to discriminate among the Clinical Global Impression - Severity scores (Mann-Whitney U test, P < 0.001). Conclusions: The TOOL questionnaire shows appropriate feasibility, reliability, and discriminative performance as a patient-reported outcome. TOOL constitutes a valuable addition to measure the impact of adverse events of antipsychotic drugs from the patient perspective.