Research team: Alonso J (Lead researcher), Ferrer M, Herdman M, Rajmil L, Valderas JM, Vilagut G
Summary: The objective of the study was to develop, validate, apply and disseminate a new tool (EMPRO) to provide standardized and consensus-based assessments of the quality of Patient Reported Outcomes (PRO) questionnaires. THe evaluation tool is based on the on the recommendations of the Scientific Committee of the Medical Outcomes Trust (MOT) and consists of 39 questions covering 8 attributes of PRO instruments. The evaluation process was based on the AGREE (Appraisal of Guidelines Research and Evaluation) collaboration model. At least 2 expert appraisers evaluate each PRO instrument individually using the EMPRO questionnaire followed by two rounds of a consensus-building procedure.
A specially developed scoring algorithm provides a score per attribute as well as an overall score for the PRO instruments evaluated. Paper and on-line versions of the tool were developed in both Spanish and English.
The Spanish version of the instrument demonstrated its reliability and validity in a pilot test with 5 health-related quality of life (HRQOL) instruments and it has since been used to evaluate a further 14 instruments. The English version of the tool was used in an international study to evaluate 5 questionnaires to measure HRQOL in patients with heart failure. Each questionnaire was evaluated by 4 expert appraisers and user opinions on the EMPRO were obtained. The data obtained in this study will be used to assess the reliability and validity of the English version of EMPRO.
Status: The final report of the study has been presented. It included the analysis of results for the 14 additional instruments evaluated using the Spanish version of the tool as well as the results from the international heart failure study. Articles reporting the results of these evaluations are currently in preparation for submission to national and international journals, respectively.
Key words: Evaluation, measures, patient reported outcomes, validity Funding Instituto de Salud Carlos III (Exptes. PI06/90483; ETE06/450104884), CIBER en Epidemiología y Salud Pública (CIBERESP – MET010).
Dates: 21/12/2006 to 30/12/2008.
References: Valderas JM, Ferrer M, Mendívil J, Garin O, Rajmil L, Herdman M, Alonso J; the Scientific Committee on “Patient-Reported Outcomes” of the IRYSS Network. Development of EMPRO: A Tool for the Standardized Assessment of Patient-Reported Outcome Measures. Value Health 2008;11:700-708.
Valderas JM, Alonso J. Patient reported outcome measures: a model-based classification system for research and clinical practice. Qual Life Res 2008;17:1125-35.