Resumo

CORDERO SANCHEZ, Tamara; AMOROTO ROIG, Mayté  e  FERNANDEZ CERVERA, Miriela. Incorporation of the study of quality of life to clinical trials: recommendations for its use. Rev Cubana Farm [online]. 2007, vol.41, n.1. ISSN 0034-7515.

The present biobliographical review is aimed at recommending methodological aspects to be taken into account for the planning, data collection, and interpretation of the results of controlled clinical trials that introduce the evaluation of the quality of life related to health. The articles agree that the measurement of this parameter is useful if it is considered that it will provide relevant data, and recommend to use blind comparative randomised designs or with interviewer. The selection of the measurement instrument should be based on the hypothesis stated and on its reliability, validity and sensitivity to change. It should be validated and adapted in the country where the research is made. To conclude that a treatment is better than other as regards the quality of life, it is necessary that statistically significant differences had been obtained at least in 2 or 3 major dimensions of the questionnaire.

Palavras-chave : Quality of life; controlled clinical trials; protocol design..