Validation of Patient-Reported Outcome Measures in Orthopedics

Abstract

In recent years, there has been an increase in the use of questionnaires designed to measure outcomes in the medical practice. To use a questionnaire in a population different from the one for which it was originally created and designed, it is necessary to carry out a rigorous adaptation process, with a certain methodology. The objective of the present methodological guide is to describe the process of translation, cross-cultural adaptation, and validation of patient-reported outcome measures in Orthopedics and Traumatology.

Level of evidence: IV.

Keywords

clinical outcomes - patient-reported outcomes - PROMs - methodology - validation

Publikationsverlauf

Eingereicht: 12. Dezember 2020

Angenommen: 24. September 2021

Artikel online veröffentlicht:
08. Februar 2022

• Referencias

• 1 Evans JP, Smith A, Gibbons C, Alonso J, Valderas JM. The National Institutes of Health patient-reported outcomes measurement information system (PROMIS): a view from the UK. Patient Relat Outcome Meas 2018; 9: 345-352
• 2 World Health Organization, Organisation for Economic Co-operation and Development, The World Bank. Delivering quality health services: a global imperative for universal health coverage. Geneve: WHO; 2018. . Available from: https://www.worldbank.org/en/topic/universalhealthcoverage/publication/delivering-quality-health-services-a-global-imperative-foruniversal-health-coverage
• 3 Valderas JM, Alonso J. Patient reported outcome measures: a model-based classification system for research and clinical practice. Qual Life Res 2008; 17 (09) 1125-1135
• 4 Beaton D, Bombardier C, Guillemin F, Ferraz MB. Recommendations for the cross-cultural adaptation of the DASH & QuickDASH outcome measures. Institute for Work & Health. 2007; 1 (01) 1-45
• 5 Ruzbarsky JJ, Marom N, Marx RG. Measuring quality and outcomes in sports medicine. Clin Sports Med 2018; 37 (03) 463-482
• 6 Ramada-Rodilla JM, Serra-Pujadas C, Delclós-Clanchet GL. Adaptación cultural y validación de cuestionarios de salud: revisión y recomendaciones metodológicas. Salud Publica Mex 2013; 55 (01) 57-66
• 7 Beaton D, Bombardier C, Guillemin F, Ferraz MB. Recommendations for the cross-cultural adaptation of health status measures. New York. J Am Acad Orthop Surg 2002; 12: 1-9
• 8 Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol 1993; 46 (12) 1417-1432
• 9 MINSAL. Primeros y segundos resultados de ENS 2016-2017. 2018 [Revisado el 1 julio 2020] en: http://epi.minsal.cl/resultados-encuestas/
• 10 Gagnier JJ. Patient reported outcomes in orthopaedics. J Orthop Res 2017; 35 (10) 2098-2108
• 11 Lauffer A, Solé L, Bernstein S, Lopes MH, Francisconi CF. Cómo minimizar errores al realizar la adaptación transcultural y la validación de los cuestionarios sobre calidad de vida: aspectos prácticos. Rev Gastroenterol Mex 2013; 78 (03) 159-176
• 12 Tsang S, Royse CF, Terkawi AS. Guidelines for developing, translating, and validating a questionnaire in perioperative and pain medicine. Saudi J Anaesth 2017; 11 (Suppl. 01) S80-S89
• 13 Pasquali L. Instrumentos psicológicos: manual prático de elaboração. Brasília: LabPAM/IBAPP; 1999
• 14 Pasquali L. Psychometrics. Rev Esc Enferm USP 2009; 43: 992-929
• 15 Gorusch RL. Factor Analysis. 2nd ed.. Hillsdale, NJ: Lawrence Erlbaum Associates; 1983
• 16 Pedhazur RJ. Multiple Regression in Behavioral Research: Explanation and Prediction. Fort Worth, TX: Harcourt Brace College Publishers; 1997
• 17 Norton S, Ellis B, Santana Suárez B. et al. Validation of the Musculoskeletal Health Questionnaire in inflammatory arthritis: a psychometric evaluation. Rheumatology (Oxford) 2019; 58 (01) 45-51
• 18 Ackerman I. Western ontario and mcMaster universities osteoarthritis index (WOMAC). Aust J Physiother 2009; 55 (03) 213
• 19 Ponkilainen VT, Häkkinen AH, Uimonen MM, Tukiainen E, Sandelin H, Repo JP. Validation of the Western Ontario and McMaster Universities Osteoarthritis Index in Patients Having Undergone Ankle Fracture Surgery. J Foot Ankle Surg 2019; 58 (06) 1100-1107
• 20 Schnetzke M, Schüler S, Keil H. et al. Development and validation of a novel questionnaire for self-determination of the range of motion of wrist and elbow. BMC Musculoskelet Disord 2016; 17 (01) 312
• 21 Noormohammadpour P, Hosseini Khezri A, Farahbakhsh F, Mansournia MA, Smuck M, Kordi R. Reliability and validity of athletes disability index questionnaire. Clin J Sport Med 2018; 28 (02) 159-167
• 22 Castellet E, Ares O, Celaya F. et al; SEROD group. Transcultural adaptation and validation of the “Hip and Knee” questionnaire into Spanish. Health Qual Life Outcomes 2014; 12 (01) 76
• 23 Kim HJ, Yeom JS, Nam Y. et al. Validation and cross-cultural adaptation of the Korean version of the Core Outcome Measures Index in patients with degenerative lumbar disease. Eur Spine J 2018; 27 (11) 2804-2813
• 24 Lawshe CH. A quantitative approach to content validity. Person Psychol 1975; 28: 563-575
• 25 Barrett RS. Content validation form. Public Pers Manage 1992; 21 (01) 41-52
• 26 Cronbach LJ, Meehl PE. Construct validity in psychological tests. Psychol Bull 1955; 52 (04) 281-302
• 27 Cronbach LJ. Coefficient alpha and the internal structure of tests. Psychometrika 1951; 16: 297-334
• 28 Nunnally J. Psychometric Theory. New York: McGraw-Hill; 1978
• 29 Prodinger B, Taylor P. Improving quality of care through patient-reported outcome measures (PROMs): expert interviews using the NHS PROMs Programme and the Swedish quality registers for knee and hip arthroplasty as examples. BMC Health Serv Res 2018; 18 (01) 87
• 30 Peters RM, van Beers LWAH, van Steenbergen LN. et al. Similar superior patient-reported outcome measures for anterior and posterolateral approaches after Total hip arthroplasty. J Arthroplasty 2018; 33 (06) 1786-1793
• 31 Organisation for Economic Co-operation and Development (OECD). PatientReported Indicators Survey (PaRIS). 2017 . Available from: http://www.oecd.org/health/paris.htm
• 32 Canadian Institute for Health Information, Organisation for Economic Co-operation and Development. OECD Patient-Reported Indicator Surveys (PaRIS) Initiative: Patient-Reported Outcome Measures (PROMs) for Hip and Knee Replacement Surgery —International Data Collection Guidelines. Ottawa, ON: CIHI; 2019
• 33 Guic E, Galdames S, Rebolledo P. Adaptación cultural y validación de la versión chilena del Cuestionario de Discapacidad Roland-Morris. [Validation and cultural adaptation of the Chilean version of the Roland-Morris Disability Questionnaire] Rev Med Chil 2014; 142 (06) 716-722
• 34 Keller A, Wagner P, Izquierdo G. et al. Cross-cultural adaptation and validation of the VISA-A questionnaire for Chilean Spanish-speaking patients. J Orthop Surg Res 2018; 13 (01) 177
• 35 Pellegrini MJ, Poniachik R, Nuñez A, Escudero MI, Carcuro G, Cortes AA. Cross-cultural adaptation and validation of the Foot and Ankle Outcome Score (FAOS) into Spanish (Chile). Foot Ankle Surg 2020; 26 (07) 790-796
• 36 Vera-Villarroel P, Silva J, Celis-Atenas K, Pavez P. Evaluación del cuestionario SF-12: verificación de la utilidad de la escala salud mental. Rev Med Chil 2014; 142 (10) 1275-1283