OBJECTIVES: Patient-centered approaches to PRO development must account for differences in understanding and experience between patients and healthcare or COA-professionals that can drive comprehension and translatability problems. Cognitive debriefing feedback of PGIs reveals repeated and serious comprehension issues which threaten accurate assessment of instruments’ target constructs and their ability to pool data across languages. We synthesize four investigations of conceptually unclear and difficult-to-translate terminology routinely found in PGIs in order to highlight problems posed to patients and data validity, and provide guidelines for improving PGI development and translation. We show that these problems arise largely from deviations from patient-centered design approaches, and suggest practical, evidence-based solutions to improve the patient experience of completing PGIs: eliminating complex medical terminology or replacing it with patient-friendly, easily-translatable terms; and simplifying ordinal response sets to reduce conceptual clustering and improve translatability.

METHODS: We performed qualitative analysis of cognitive debriefing results, and thematic analysis of spontaneous feedback, from 996 patients representing 30 languages and 35 countries (aged 5-92 years; education 2-20 years) to assess comprehension of 16 PGIs. We conducted quantitative analysis of a response-option rating task from 115 separate patients (aged 18-75 years, education 8-17 years) from 12 English-speaking locales.

RESULTS: We identified terms that cause comprehension problems (e.g., disease activity, global) for a significant proportion of patients, languages, and countries in our samples (25%+), and further note differential comprehension based on patient language and culture. We additionally found that larger ordinal response sets (7 vs 5-item) are 3 times more likely to cause comprehension problems, and provide quantitative data showing how patients perceive the conceptual spacing of common PGI response options.

CONCLUSIONS: Despite their brevity, PGIs are prone to many design, conceptual, and translation problems. Patient-centered approaches, which avoid needlessly complex phrasing and improve translatability, are essential for improving the patient experience and increasing data validity.