OBJECTIVES

The objective of this study was to identify terminology found in PROs that causes difficulty in translation and comprehension. Identifying such terminology and solutions that improve translation and patient comprehension is critical to increasing the validity of PROs and their treatment insights. As such, we investigated use of the term disease activity in PROs across a variety of languages. Disease activity can be defined as “manifestations of a disease”, and typically appears in instruments assessing the state of a patient’s disease signs and symptoms.

METHODS

RWS Life Sciences translated and harmonized four Patient’s Assessment of Disease Activity instruments into 42 languages for 41 countries across four translation projects (for a total of 102 translations). The harmonized questionnaires underwent in-person cognitive interviews with psoriatic arthritis and ankylosing spondylitis patients. We extracted patient demographic and item comprehension information, as well as feedback related to comprehension problems, from 515 interviews.

RESULTS

Patients (n = 515) were aged 18-92 years (mean = 51.2), with length of education ranging from 2-20 years (mean = 12.7). Difficulty comprehending disease activity was noted in 33 of 102 translations (32%), and accounted for 35% of the total number of comprehension errors. Patient feedback indicated that common issues interpreting disease activity arose from it being “too clinical”, misinterpreted as physical activity, or conflated with the concept of pain, while suggested revisions included adding the concept of the disease’s progress or current state, or amending disease activity to “disease activity level / amount”.

CONCLUSIONS

Due to the ambiguity and unfamiliarity of the disease activity concept, difficulties in translation and comprehension commonly arise in PROs that employ it. We note several suggestions for increasing the comprehensibility of disease activity, and recommend explicit elaboration of disease activity to focus patients on overall symptoms or the state of the disease.