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

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. Plain Language Summary: It is important to understand the personal treatment goals of people being treated for health problems. These goals can help to focus treatment decisions on the symptoms and impacts that matter most to patients. Treatments often produce a variety of effects. Measuring progress toward achieving individual goals can help patients and doctors know if the treatments are working in ways that are meaningful. Doctors and researchers often use standardized assessments to gather information from people about their health conditions, but standardized measures do not necessarily assess the things that a specific person may care about. In this study, we developed a tool that helps people with a given health condition to (1) determine their main treatment goal, (2) measure their progress toward that goal, and (3) help decide whether the progress toward their goal is enough to be meaningful to them. The tool is called the Treatment Goal Evaluation Scale (TGES). Though it is meant to be used with a wide variety of conditions, it was tested first with people who have atopic dermatitis (eczema) or migraines. We found that the TGES is useful at helping people identify and measure progress on their main treatment goal. By focusing on a goal that is personally meaningful, the TGES might one day help personalize the treatment experience for individuals with a variety of health conditions. Keywords: instrument development, patient-reported outcomes, treatment outcome, meaningful within-patient change, patient care planning, goals of care