VALIDATION OF THE SPANISH VERSION OF THE SELF-ESTEEM AND RELATIONSHIP (SEAR) QUESTIONNAIRE FOR MEN WITH ERECTILE DYSFUNCTION (ED)
Author(s)
Rejas J1, Cabello F2, Calle A3, Chantada V4, Forà F5, Garcia-Garcia M6, Rico-Villademoros F7, Martínez-Sánchez EM1, 1 Pfizer SA, Alcobendas, Madrid, Spain; 2 Instituto Andaluz de Sexología, Málaga, Spain; 3 Hospital Clínico San Carlos, Madrid, Spain; 4 Hospital Juan Canalejo, La Coruña, Spain; 5 Centro Médico Teknon, Barcelona, Spain; 6 Biométrica CRO, Barcelona, Spain; 7 Biométrica CRO, Madrid, Spain
OBJECTIVES: To assess the clinimetric properties of the Spanish version of the Self-Esteem And Relationship (SEAR) questionnaire to be used in Spain with patients with ED. METHODS: The SEAR questionnaire comprises 14 items divided into two domains: Sexual Relationship (8 items) and Confidence (6 items), the latter comprising Self-Esteem (4 items) and Overall Relationship (2 items). The USA-English-version of SEAR questionnaire was adapted linguistically into Spanish by using forward and back translation methods and a conceptual equivalence approach. The SEAR questionnaire was administered to a group of patients with ED (IIEF<26) seven days before starting treatment and at baseline and after three months of treatment (group A), and to a group of healthy control subjects (IIEF≥26) (group B) in a single visit. SF-12 and HAD scales were also administered. RESULTS: Out of 831 recruited subjects (n=732, group A; n=99, group B), 559 subjects were included as evaluable for validation analysis (n=504, group A; n=55, group B). The percentage of patients without response was < 5% for all domains. Cronbach's Alpha coefficient was 0.92 and 0.86 in groups A and B. The SEAR questionnaire discriminated between patients and controls (area under curve =0.999) and groups of patients by severity of ED (Kruskall-Wallis test: p<0.0001). Correlation was high with Erectile Function scale of IIEF (r=0.69) and moderate with HAD (r=-0.41) and SF-12 Mental Health (r=0.38). The SEAR questionnaire also showed responsiveness with improvement in scores from start to end of treatment (Mann-Whitney-Wilcoxon test: p<0.0001). CONCLUSIONS: The SEAR questionnaire showed adequate feasibility, reliability, validity and responsiveness for its use for measuring the emotional tension and relationship difficulties associated with erectile dysfunction.
Conference/Value in Health Info
2004-10, ISPOR Europe 2004, Hamburg, Germany
Value in Health, Vol. 7, No. 6 (November/December 2004)
Code
PMW4
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Reproductive and Sexual Health