OBJECTIVES: Since the publication of the FDA PRO Guidance in 2009, focus has largely been dedicated to patient-reported outcomes measures. Other commonly used clinical outcomes assessments including clinician-reported outcomes (Clin-RO) and observer-reported outcomes (Obs-RO) warrant attention, as the expectation is that all clinical outcomes assessments will be expected to follow the properties of the PRO guidelines. It can be inferred that the same expectations for translation and cultural adaptation of these measures will also apply, and discussion surrounding translation methodologies for these outcomes measures is necessary. METHODS: A review of past Clin-RO and Obs-RO measure translation methodologies was conducted. Linguistic feedback resulting from each stage was reviewed for relevance and impact on language changes. RESULTS: Past translation methodologies involved concept definition, dual forward translation, reconciliation of forward translations, back translation, resolution of back translation and forward translation, and clinician or expert review for all clinical outcomes assessments. An additional stage specific to observer-reported outcomes assessments included cognitive interviewing with the relevant respondent population, such as caregivers, parents, etc. Clin-RO measures involve review by native-speaking clinicians in the relevant area of interest. Cognitive interviews with clinicians were not found to be a common practice. CONCLUSIONS: The results of this review and feedback analysis suggest observer-reported outcomes measures are best suited to follow the same methodology as PRO measures, with the cognitive interviews conducted with the relevant observer population. Clinician-reported outcomes measures should also follow the same guidelines as PRO measures for translation, however further research into the methodology for execution of the review stage is required to assess if clinician reviews, focus groups with clinicians, cognitive interviews with clinicians, or an alternative will yield the best results for this particular clinical outcomes assessment.