Abstract
Within current literature and practice, the category of patient-reported outcome (PRO) measures has been expanded into the broader category of clinical outcome assessments (COAs), which includes the subcategory of PRO, as well as clinician-reported outcome (ClinRO), observer-reported outcome (ObsRO), and performance outcome (PerfO) measure subcategories. However, despite this conceptual expansion, recommendations associated with translation, cultural adaptation, and linguistic validation of COAs remain focused on PRO measures, which has created a gap in specific process recommendations for the remaining types. This lack of recommendations has led to inconsistent approaches being implemented, leading to uncertainty in the scientific community regarding suitable methods. To address this gap, the ISOQOL Translation and Cultural Adaptation Special Interest Group (TCA-SIG) has developed recommendations specific to each of the three COA types currently lacking such documentation to support a standardized approach to their translation, cultural adaptation, and linguistic validation. The recommended process utilized to translate ObsRO, ClinRO and PerfO measures from one language to another aligns closely with the industry standard process for PRO measures. The substantial differences between respondent categories across COA types require targeted approaches to the cognitive interviewing procedures utilized within the linguistic validation process, including the use of patients for patient-facing text in ClinRO measures, and the need to interview the targeted observers for ObsROs measures.
Highlights
Clinical outcome assessments (COAs), defined by the United States Food and Drug Administration (FDA) as tools that “measure a patient’s symptoms, overall mental state, or the effects of a disease or condition on how the patient functions,” are widely utilized within globalMcKown et al Journal of Patient-Reported Outcomes (2020) 4:89 than the broader category of COAs
Volunteers were solicited for lead and contributing author roles based on COA type, with a different lead volunteering for each of the three non-patient-reported outcome (PRO) COA types (ObsRO, clinician-reported outcome (ClinRO), performance outcome (PerfO))
Our research found that the process utilized to translate observer-reported outcome (ObsRO), ClinRO and PerfO measures from one language to another aligns closely with the process outlined in the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) recommendations for translation and cultural adaptation of PRO measures
Summary
Clinical outcome assessments (COAs), defined by the United States Food and Drug Administration (FDA) as tools that “measure a patient’s symptoms, overall mental state, or the effects of a disease or condition on how the patient functions,” are widely utilized within globalMcKown et al Journal of Patient-Reported Outcomes (2020) 4:89 than the broader category of COAs. Utilization of the broader COA concept, encouraging readers to consider PRO measures as one of several COA types rather than as the primary focus, likely entered the dialogue in 2013 with the FDA’s release of the COA Roadmap to Patient-Focused Outcome Measurement [3]. This roadmap encouraged clinical trial personnel to select from the four COA types noted above to measure clinical benefit in treatment trials. In 2014, FDA released the Qualification Process for Drug Development Tools, which further developed this shift and featured guidance for COA qualification, encouraging users to select specific COA types as part of the trial planning process [4]. In 2018, FDA expanded this approach by releasing a Patient-Focused Drug Development (PFDD) draft guidance which highlighted recommended processes for selecting, developing or modifying fit-for-purpose COAs [5]
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