Raquel Vicente Lidón1, Santiago García López2, Pilar Corsino Roche2, José Miguel Boudet Barraca3, Patricia Sanz Segura4, Paula García Cámara5, Eva Sierra Moros3, Fernando Gomollón García6. 1. Unidad de Enfermedad Inflamatoria Intestinal, Servicio de Aparato Digestivo, Hospital Universitario Miguel Servet, Zaragoza, España; Instituto de Investigación Sanitaria de Aragón, Zaragoza, España. Electronic address: raquelvicentelidon@gmail.com. 2. Unidad de Enfermedad Inflamatoria Intestinal, Servicio de Aparato Digestivo, Hospital Universitario Miguel Servet, Zaragoza, España; Instituto de Investigación Sanitaria de Aragón, Zaragoza, España. 3. Unidad de Enfermedad Inflamatoria Intestinal, Servicio de Aparato Digestivo, Hospital Universitario Miguel Servet, Zaragoza, España. 4. Unidad de Enfermedad Inflamatoria Intestinal, Servicio de Aparato Digestivo, Hospital Universitario Miguel Servet, Zaragoza, España; Servicio de Aparato Digestivo, Hospital Royo Villanova, Zaragoza, España. 5. Unidad de Enfermedad Inflamatoria Intestinal, Servicio de Aparato Digestivo, Hospital Universitario Miguel Servet, Zaragoza, España; Sección de Aparato Digestivo, Hospital Comarcal de Laredo, Laredo, Santander, España. 6. Instituto de Investigación Sanitaria de Aragón, Zaragoza, España; Servicio de Aparato Digestivo, Hospital Clínico Universitario Lozano Blesa, Zaragoza, España; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Zaragoza, España.
Abstract
OBJECTIVE: Measurement of patient-perceived outcomes in inflammatory bowel disease (IBD) care is becoming increasingly important. A simple and validated tool exists in English for this purpose, the "IBD-Control". Our aim is to translate it into Spanish, adapt and validate it. PATIENTS AND METHODS: The IBD-Control was translated into the Spanish instrument "EII-Control" and prospectively validated. Patients completed the EII-Control and other questionnaires that served as baseline comparators. The gastroenterologist performed a global assessment of the disease, calculated activity indices and recorded treatment. A subgroup of patients repeated the entire assessment at a second visit. The usefulness of IBD-Control summary scales (IBD-Control-8 and IBD-Control-VAS) was also analysed. RESULTS: A total of 249 IBD patients were included (101 repeated the second visit). Psychometric standards of the test: internal consistency: Cronbach's α for EII-Control 0.83 with strong correlation between EII-Control-8 and EII-Control-EVA (r=0.5); reproducibility: intra-class correlation 0.70 for EII-Control; construct validity: moderate to strong correlations between IBD-Control, IBD-Control-8 and IBD-Control-VAS versus comparators; discriminant validity: P<.001; sensitivity to change: same response as quality of life index. Sensitivity and specificity at cut-off point 14 of 0.696 and 0.903, respectively, to determine quiescent status. CONCLUSIONS: The IBD-Control is a valid instrument to measure IBD-Control from the patient's perspective in our environment and culture. Its simplicity makes it a useful tool to support care.
OBJECTIVE: Measurement of patient-perceived outcomes in inflammatory bowel disease (IBD) care is becoming increasingly important. A simple and validated tool exists in English for this purpose, the "IBD-Control". Our aim is to translate it into Spanish, adapt and validate it. PATIENTS AND METHODS: The IBD-Control was translated into the Spanish instrument "EII-Control" and prospectively validated. Patients completed the EII-Control and other questionnaires that served as baseline comparators. The gastroenterologist performed a global assessment of the disease, calculated activity indices and recorded treatment. A subgroup of patients repeated the entire assessment at a second visit. The usefulness of IBD-Control summary scales (IBD-Control-8 and IBD-Control-VAS) was also analysed. RESULTS: A total of 249 IBD patients were included (101 repeated the second visit). Psychometric standards of the test: internal consistency: Cronbach's α for EII-Control 0.83 with strong correlation between EII-Control-8 and EII-Control-EVA (r=0.5); reproducibility: intra-class correlation 0.70 for EII-Control; construct validity: moderate to strong correlations between IBD-Control, IBD-Control-8 and IBD-Control-VAS versus comparators; discriminant validity: P<.001; sensitivity to change: same response as quality of life index. Sensitivity and specificity at cut-off point 14 of 0.696 and 0.903, respectively, to determine quiescent status. CONCLUSIONS: The IBD-Control is a valid instrument to measure IBD-Control from the patient's perspective in our environment and culture. Its simplicity makes it a useful tool to support care.
Keywords:
Cuestionario breve; Enfermedad inflamatoria intestinal; Inflammatory bowel disease; Medida de los resultados reportados por los pacientes; Patients reported outcomes; Patients reported outcomes measure; Resultados reportados por los pacientes; Short questionnaire; Traducción; Translation; Validación; Validation