Presentation (CTI)

OBJECTIVES: Goal Attainment Scaling (GAS) is a valuable outcome measure adept at capturing patient priorities and was recently acknowledged as such in the US Food & Drug Administration’s Patient-Focused Drug Development (PFDD) Guidance. GAS’s implementation in research requires standardization to ensure rigor. To understand how GAS is currently implemented, we reviewed registered clinical trials with GAS as an endpoint.
METHODS: We searched ClinicalTrials.gov using the keywords “goal attainment scale” or “goal attainment scaling” in trials registered in the last decade (01/2016 - 12/2025). We excluded trials that were terminated, suspended, withdrawn, or used GAS as an intervention. Reported clinical conditions were categorized using the 11th International Classification of Disease (ICD-11) taxonomy. Trials beginning after the release of the draft PFDD Guidance 4 (04/2023) were selected for in-depth review regarding GAS standardization.
RESULTS: Of 368 trials identified, 296 were eligible for our review. GAS was reported as a primary endpoint in 39% of trials (n=115) and a secondary endpoint in 52% (n=154). GAS was most often operationalized in the ICD-11 subcategories: neurodevelopmental disorders (18%, n=53); cerebral palsy (11%, n=34); and cerebrovascular disease (11%, n=34). Over the last five years, GAS use increased 17% (n = 52) compared to the previous five years. Of the 135 trials started after the PFDD Guidance 4 release, 19 had documentation available for review. From this subset, four did not report on GAS, and nine others reported no additional details on GAS implementation. Details of GAS standardization found in trial documentation include the use of a goal inventory (n=2), patient education on goal setting (n=2), and setting a recommended number of goals (n=5).
CONCLUSIONS: Over the last decade, GAS has become an increasingly popular endpoint in trials; however, how it is being implemented is unclear. Reporting guidelines are needed for transparency in GAS implementation.