LAUSR

A patient-reported outcome (PRO) is a measure based on a report about a patient’s health status and function that comes directly from the patient [1]. A PRO instrument is used to capture data from patients in clinical trials and clinical practice to evaluate their perspective and experience. Evidence generated on PROs is used by regulators, payers, employers, providers, and patients to inform clinical decision-making. A novel PRO instrument to help understand the importance of hunger, appetite, cravings, and satiety in chronic weight management was developed in a manner consistent with the United States Food and Drug Administration’s PRO guidance [1]. The instrument measures the four eating concepts of hunger, appetite, cravings, and satiety while being clear, easy to answer, and easy for patients to recall. In order to better understand patients’ definitions, experiences, and the importance of eating-related factors in chronic weight management, interviews with overweight and obese patients were conducted [2]. Patients defined the concept of hunger as the physical need to eat. Appetite was defined as the desire to eat, interest in eating, or the amount of food desired. Patients described satiety as a state of feeling comfortably full and satisfied after eating, and thought of it as the absence or opposite of hunger. Cravings are a desire, rather than a physical need, to eat a specific and typically unhealthy type of food. The concepts of satiety and hunger were considered physical factors that are related to the quantity of food consumed, whereas cravings and appetite were psychological factors that impact the choice of food. A conceptual model was developed to capture the hypothesized relationships among the four eating concepts and their influence on both food quantity and choice (Fig. 1). Participant feedback on the model revealed that the concepts of hunger and cravings were easier to define, describe, and differentiate; however, all four concepts were deemed important in chronic weight management. The four eating-related concepts can be challenging to describe in a patient-friendly manner, so the decision was made to include patients in the process of naming the novel PRO instrument to ensure that the name is meaningful to patients. This approach supports patient-focused drug development (PFDD) initiatives by including the patient’s voice in drug development and evaluation [3]. Additionally, it is anticipated that selecting a name that resonates with patients will help increase their understanding, utility, and compliance with completing the instrument, which will be important since the novel PRO instrument was developed for use in clinical practice in addition to clinical research. A two-step approach was utilized to name the instrument in a way that would resonate with patients. Stream I included a naming activity and internal validation; stream II focused on external patient validation. In stream I, the research team had an internal brainstorming session during which over 100 name options were drafted. After narrowing down this list to the top name choices following the research team’s cocreation review sessions, regulatory and competitive due diligence was conducted to flag naming similarities or any potential for market confusion. Two rounds of naming recommendations took place to narrow down the options before external validation. The first round cut the field of names down to 10, which was then narrowed down further in the second round to five names. The final five names for external validation were: (1) Daily Eats: Daily Eating Factors; (2) Quick TASTE: Triggers Associated To Eating; (3) DASH-C: Daily Index of Appetite, Satiety, Hunger, and Craving; (4) DINE 5Q: Drivers INfluencing Eating; (5) Eat Pulse: Diary of Eating Drivers. Stream II sought patient validation to determine the best name for the new PRO instrument. Eligible participants were adults aged ≥ 18 years who were overweight or obese, had * John Fastenau [email protected]