Álvaro Milán, Jose Luís Peña, Joaquín Ayerbe, Dolores Vázquez, Alejandra Cano, Luis Manuel Zamora González, Ignacio Gómez-Ochoa, Gonzalo Bolado, Francisco M. Kovacs, David Martí, Joan Bagó, Mariano Ortega, Ana Ausín, Javier Zamora, Ana Royuela, Ricardo Blanco, Ma Trinidad Rueda, Montserrat Núñez, Alejandro Carballo, José Luis Ortega Martín, Eva Calvo, Leovigildo Ginel, Nuria Gimeno, Anna Vidal, Sergio Giménez, Miquel Tomás, Víctor Abraira, Mario Gestoso, María Teresa Gil del Real, Jesús Seco, Alfonso Muriel, Ma José Ramírez, Montserrat Cañellas, Salvador Fuster, María Antonia Mir, Pilar Brieva, Miryam Bernal, Nicole Mufraggi, Carmen Fernández, Luis Alvarez, Domingo Ramón, Josep Corcoll, Ma Dolores Castillo, Universitat de Barcelona, [Kovacs,FM, Real,MTG del] Departamento Científico, Fundación Kovacs, Palma de Mallorca, Spain. [Bagó,J] Unidad de Cirugía del Raquis, Hospital Vall d'Hebrón, Barcelona, Spain. [Royuela,A, Muriel,A, Abraira,V, Zamora,J, Cano,A] Unidad de Bioestadística Clínica, Hospital Ramón y Cajal, Madrid, Spain. [Seco,J] Departamento de Enfermería y Fisioterapia, Universidad de León, Ponferrada, Spain. [Giménez,S, Milán,A] Centro de Salud del Limonar, Málaga, Spain. [Martín,JL, Rueda,MT] Servicio de Medicina Preventiva, Hospital de Rehabilitación y Traumatología Virgen de las Nieves, Granada, Spain. [Peña,JL, Blanco,R] Servicio de Reumatología, Hospital Marqués de Valdecilla, Santander, Spain. [Gestoso,M, Mufraggi,N] Clínica Kovacs, Fundación Kovacs, Palma de Mallorca, Spain. [Núñez,M, Fuster,S] Servicio de Cirugía Ortopédica y Traumatología, Hospital Clínico, Barcelona, Spain. [Corcoll,J] Centro de Salud de Tramuntana Esporlas, Mallorca, Spain. [Gómez-Ochoa,I] Servicio de Rehabilitación, Hospital Lozano Blesa, Zaragoza, Spain. [Ramírez,MJ, Calvo,E, Brieva,P] Unidad de Rehabilitación, Hospital Marqués de Valdecilla, Santander, Spain. [Castillo,MD] Delegación Asuntos Sociales, Granada, Spain. [Martí,D, Gimeno,N, Carballo,A, Vidal,A] Servicio de Traumatología y Ortopedia, Hospital Parc Taulí de Sabadell, Barcelona, Spain. [Fernández,C] Centro de Salud de Valldargent, Palma de Mallorca, Spain. [Vázquez,D] Servicio de Rehabilitación, Mutua Asepeyo, Madrid, Spain. [Cañellas,M] Servicio de Anestesia, Hospital Parc Taulí de Sabadell, Barcelona, Spain. [Álvarez,L] Servicio de Traumatología, Fundación Jiménez Díaz, Madrid, Spain. [Ayerbe,J] Servicio de Neurocirugía, Fundación Jiménez Díaz, Madrid, Spain. [González,L] Centro de Salud Serrería II, Valencia, Spain. [Ginel,L] Centro de Salud de Ciudad Jardín, Málaga, Spain. [Ortega,M] Centro de Salud de Es Trencadors de Lluchmajor, Mallorca, Spain. [Bernal,M, Bolado,G] Servicio de Rehabilitación, Hospital Clínico Universitario, Valladolid, Spain. [Ausín,A, Ramón,D] Unidad Básica de Es Castell, Menorca, Spain. [Mir,MA] Centro de Salud de Inca. Mallorca, Spain. [Tomás,M] Servicio de Emergencias 061. Mallorca, Spain., and This study was funded by the Kovacs Foundation.
Comparative Study; Journal Article; Multicenter StTrial Registration:; Research Support, Non-U.S. Gov't; Clinical Trials Register NCT00349544. BACKGROUND. The NDI, COM and NPQ are evaluation instruments for disability due to NP. There was no Spanish version of NDI or COM for which psychometric characteristics were known. The objectives of this study were to translate and culturally adapt the Spanish version of the Neck Disability Index Questionnaire (NDI), and the Core Outcome Measure (COM), to validate its use in Spanish speaking patients with non-specific neck pain (NP), and to compare their psychometric characteristics with those of the Spanish version of the Northwick Pain Questionnaire (NPQ). METHODS. Translation/re-translation of the English versions of the NDI and the COM was done blindly and independently by a multidisciplinary team. The study was done in 9 primary care Centers and 12 specialty services from 9 regions in Spain, with 221 acute, subacute and chronic patients who visited their physician for NP: 54 in the pilot phase and 167 in the validation phase. Neck pain (VAS), referred pain (VAS), disability (NDI, COM and NPQ), catastrophizing (CSQ) and quality of life (SF-12) were measured on their first visit and 14 days later. Patients' self-assessment was used as the external criterion for pain and disability. In the pilot phase, patients' understanding of each item in the NDI and COM was assessed, and on day 1 test-retest reliability was estimated by giving a second NDI and COM in which the name of the questionnaires and the order of the items had been changed. RESULTS. Comprehensibility of NDI and COM were good. Minutes needed to fill out the questionnaires [median, (P25, P75)]: NDI. 4 (2.2, 10.0), COM: 2.1 (1.0, 4.9). Reliability: [ICC, (95%CI)]: NDI: 0.88 (0.80, 0.93). COM: 0.85 (0.75,0.91). Sensitivity to change: Effect size for patients having worsened, not changed and improved between days 1 and 15, according to the external criterion for disability: NDI: -0.24, 0.15, 0.66; NPQ: -0.14, 0.06, 0.67; COM: 0.05, 0.19, 0.92. Validity: Results of NDI, NPQ and COM were consistent with the external criterion for disability, whereas only those from NDI were consistent with the one for pain. Correlations with VAS, CSQ and SF-12 were similar for NDI and NPQ (absolute values between 0.36 and 0.50 on day 1, between 0.38 and 0.70 on day 15), and slightly lower for COM (between 0.36 and 0.48 on day 1, and between 0.33 and 0.61 on day 15). Correlation between NDI and NPQ: r = 0.84 on day 1, r = 0.91 on day 15. Correlation between COM and NPQ: r = 0.63 on day 1, r = 0.71 on day 15. CONCLUSION. Although most psychometric characteristics of NDI, NPQ and COM are similar, those from the latter one are worse and its use may lead to patients' evolution seeming more positive than it actually is. NDI seems to be the best instrument for measuring NP-related disability, since its results are the most consistent with patient's assessment of their own clinical status and evolution. It takes two more minutes to answer the NDI than to answer the COM, but it can be reliably filled out by the patient without assistance. TRIAL REGISTRATION Clinical Trials Register NCT00349544. Yes