Development and Content Validity Evaluation of the Condition-Agnostic Treatment Goal Evaluation Scale (TGES) for Use in Chronic Conditions.

Abstract

Background: Patient-reported outcomes (PROs) are important for understanding patients' experiences with their health conditions; however, individual perspectives of meaningful change for personalized treatment goals are rarely captured. Consequently, treatment outcomes assessed in clinical trials or routine practice may not align with real-world priorities or reflect individual perspectives. To bridge this gap, we developed the 2-part treatment goal evaluation scale (TGES) to assess individuals' perspectives of whether meaningful within-patient change has occurred in their self-identified treatment goal.

Methodology: The draft TGES measure included the TGES - Baseline-a single, open-ended item to identify patients' primary treatment goal when starting a new treatment for a new or ongoing condition-and the TGES - Follow-Up-2 items designed to assess patients' perspectives of whether meaningful change has occurred in their self-identified goal and overall condition. Three rounds of qualitative interviews with adults aged ≥18 years with either atopic dermatitis (AD) or migraine were conducted to revise the draft TGES and assess content validity.

Results: A total of 28 participants with AD (n=15) or migraine (n=13) were included; most identified as female (60.7%) and White (78.6%). Most participants interpreted the TGES - Baseline instructions (82.1%) and item (96.4%) as intended, whereas 39.3% suggested revisions to the instructions. Overall goal categories were identified: 3 AD-specific (improving physical symptoms, sensory symptoms, and choice of clothing) and 4 migraine-specific (reduced migraine frequency, impact on activities, migraine severity, and associated symptoms other than headache). Most participants interpreted the TGES - Follow-Up instructions (100.0%) and items (96.4%; 75.0%) as intended, with minor revisions suggested to improve clarity.

Conclusion: Qualitative interviews supported the content validity of the TGES for identifying individual treatment goals and assessing perspectives of meaningful change. With future quantitative evaluation, the patient-centric and condition-agnostic TGES may help evaluate personalized endpoints and inform within-patient meaningful change in clinical trial and real-world settings.