OBJECTIVES

: Identifying problematic terminology and proposing solutions for improved translation is critical to increasing PRO content validity and the quality of respondent data. We examined patients’ comprehension of the terms self­-conscious and embarrassed, which have considerable semantic overlap and frequently appear together in PROs. Self-conscious can be defined as uncomfortable or intense awareness of being observed or of how one is perceived, while embarrassed connotes more negative qualities of feeling shame or distress and loss of dignity, but is also frequently defined as uncomfortable self-consciousness.

METHODS

: RWS Life Sciences translated and harmonized three PROs containing items on self-consciousness and embarrassment into 40 languages for 50 countries across three translation projects (for 72 total translations). The harmonized questionnaires underwent in-person cognitive interviews with atopic dermatitis and head & neck cancer patients. We extracted patient demographic and item comprehension information, as well as feedback regarding comprehension problems, from 356 interviews.

RESULTS

: Patients (n = 356) were aged 11-95 years, with length of education from 0-20 years (mean = 11.9). Comprehension problems with self-conscious and embarrassed were noted in 12 / 39 languages (31%), 14 / 50 countries (28%), 17 / 72 translations (24%), and accounted for 55% of the total number of comprehension errors across all debriefing sessions. Patients reported that self-conscious and embarrassed were difficult to separate conceptually, and suggested that only one of the concepts was necessary. Patients also had difficulty comprehending / paraphrasing self-conscious itself, and were frequently unable to provide alternative translations.

CONCLUSIONS

: Patients demonstrated considerable difficulty interpreting the terms self-conscious and embarrassed in three PROs. We attribute this to their semantic overlap and co-occurrence in contexts where they are intended to assess different constructs. We recommend greater effort to differentiate self-conscious and embarrassed in PROs containing both in order to improve comprehensibility and translations of both terms.