Presentation (CTI)

OBJECTIVES: Goal attainment scaling (GAS) was recently recognized by the US Food and Drug Agency (FDA) as a personalized outcome measure that can support patient-focused drug development. Per FDA guidance, rigorous implementation requires standardization in how GAS is conducted within a study. Increasingly, condition-specific item banks of patient treatment goals, called goal inventories, are being developed to help standardize GAS processes; align goals with the target intervention’s mechanism of action; and provide a common language for patients and clinicians. To date, there are no comprehensive investigations of inventory development. In this study, we conducted a landscape analysis of the literature on goal inventory development.
METHODS: We conducted a review of peer-reviewed publications in the past 10 years reporting the development of GAS goal inventories. Search terms included permutations of “goal attainment scal*”, “inventory” and “menu”. Data were extracted on: clinical context; intervention-specific adaptations; methodological approaches; and stakeholder engagement
RESULTS: Our search identified 15 eligible publications reporting the development of 11 goal inventories. Inventories were developed for clinical conditions (e.g., hemophilia; n = 8); clinical contexts (e.g., older adults in primary care; n = 2); or both (e.g., prolonged disorders of consciousness in rehabilitation; n = 1). None were adapted for a specific intervention. While all inventories were developed using qualitative methods, specific analytic approaches varied (e.g., content analysis). Only 4 inventories also used quantitative methods. All inventories engaged stakeholders during development, primarily individuals with lived experience or their caregivers (n = 9) and clinical experts (n = 8).
CONCLUSIONS: While the included goal inventories employed different approaches to development, all used qualitative methods and stakeholder engagement, underscoring GAS’s patient-centricity. Notably, although clinical trials require that GAS goals align with the intervention’s mechanism of action, no inventories reported intervention-specific adaptations. Intervention-specific adaptations may offer an avenue to further standardize the GAS process in clinical trials.