THE SPANISH VERSION OF THE TOOL QUESTIONNAIRE- A USEFUL MEASURE FOR EVALUATING THE HRQOL AND UTILITIES FROM SCHIZOPHRENIC AND BIPOLAR PATIENTS
Author(s)
Luis Cordero, PhD, Patient Safety Manager1, Jorge Maurino, MD, Medical Affairs Manager1, AL Montejo, MD, Dr2, Pablo Rebollo, MD, PhD, Scientific Director3, Jesus Cuervo, PhD, Project Manager3, Teresa Diez, MD, Head of Neuroscience1, Monica Tafalla, MD, MPH, Head of Epidemiology1, Ramón Hernandez, MD, MPH, PhD, Head Value Demonstration Unit11AstraZeneca Farmacéutica Spain S.A, Madrid, Spain; 2 Salamanca University, Salamanca, Spain; 3 BAP Health Outcomes Research, Oviedo, Spain
OBJECTIVES: Develop a cross-cultural translation, Swedish to Spanish, of TOOL questionnaire - a previously validated instrument to assess the impact of adverse effects (AE) on the health utilities and health related quality of life (HRQoL) in patients with schizophrenia and bipolar disorder. METHODS: TOOL questionnaire has 8 attributes and 4 levels per domain (Likert scale). These domains are mood (anxiety and depression), function capabilities, and AE frequently associated with antipsychotic drugs (fatigue-weakness, weight gain, stiffness-tremor, physical restlessness, sexual dysfunction, and vertigo-nausea). Firstly, 4 independent translators (3 Spanish and 1 Swedish) carried out the forward-backward translations of the original TOOL questionnaire. Next, draft version was reviewed by an experts panel (5 psychiatrists & 1 GP specialized in HRQoL) and tested in 40 stable patients (20 schizophrenic & 20 bipolar). Regarding patients´ responses, comprehension and importance (C/I) of each item were evaluated by using a Likert scale ranging from 0 (lowest level of C/I) to 4 (highest level of C/I). Furthermore, feasibility and internal consistency were preliminary analyzed. RESULTS: According to experts´ criteria 3 items should be modified to facilitate comprehension: mood, physical restlessness and vertigo-nausea. However, C/I of items mean scores were respectively: mood (3.50/ 2.37); function capabilities (2.58/ 2.03); fatigue-weakness (3.58/ 2.55); weight gain- (3.75/ 2.87); stiffness-tremor (3.65/ 2.61); restlessness (3.37/ 2.62); sexual dysfunction (3.39/ 2.51) and vertigo-nausea (3.56/ 2.44). Furthermore, only 2 patients (5%) were unable to complete this questionnaire. Internal consistency was high (Cronbach α= 0.87) and neither item ceiling nor floor effects were found in patients responses. Finally, the Spanish version of the TOOL questionnaire was reached by consensus. CONCLUSIONS: The Swedish TOOL questionaire was culturally adapted into Spanish. Psychometric analyses are needed to validate this HRQoL measure in Spain. Moreover, a multtiatribute utility fuction should be estimated to evaluate AE by using a patients´centered perspective.
Conference/Value in Health Info
2008-11, ISPOR Europe 2008, Athens, Greece
Value in Health, Vol. 11, No. 6 (November 2008)
Code
PMH43
Topic
Patient-Centered Research
Topic Subcategory
Health State Utilities, Patient-reported Outcomes & Quality of Life Outcomes, Stated Preference & Patient Satisfaction
Disease
Mental Health