Modification for efficiency of the EORTC QOL cultural adaptation protocol

Objective: The purpose of this qualitative study was to assess adding an interim step to the cultural adaptation translation protocol of the European Organization for Research and Treatment of Cancer (EORTC) of the general quality of life instrument to increase the study efficiency in populations with low literacy levels.

Methods: The general (QLQ-C30) instrument was translated to Puerto Rican-Spanish from American-Spanish according to EORTC guidelines. Two translators independently reviewed the questionnaires to identify items requiring modification to reflect the language in common use in Puerto Rico; two questions were identified for modification. The modified instrument was administered to five lay subjects prior to the validation pilot test (n=17). Each of the five subjects was interviewed for any problems in the wording of each question. The data gathered in this step was use to again modify the instrument.

Results: Subjects (4 males, 1 female) had significant difficulties with five of thirty questions (17%). These consisted of the two questions (7%) that the translators identified and three (10%) additional questions. No subject in the validation pilot test (n=17) had difficulties with the modified wording of the five questions. The average schooling completed was 6th grade.

Conclusions: The proposed modification to the EORTC cultural adaptation protocol adds a preliminary administration of the initial translated instrument prior to the pilot validation. This step may increase the accuracy of the instruments' translation by professionals to better reflect lay language. This “pilot of the pilot” should be considered a part of the translation step in the cultural adaptation of the QOL instruments to increase the efficiency of the cultural adaptation and minimizing the need to repeat the full pilot validation. This process may be considered in countries where the professional translation may not adequately reflect the common language, perhaps due to low educational/literacy levels.

Supported by NIH NRSA T32 DE 007255