OBJECTIVES: Currently no PRO instrument has been developed to capture HABP patients’ symptoms and functioning. The goals of this study were to identify patient-reported HABP symptoms and impacts to develop items for a new HABP PRO instrument. METHODS: Patients were recruited at four US clinical sites. The study was conducted in two stages via telephone interviews. One-on-one concept elicitation (CE) interviews were conducted until concept saturation was achieved. In developing items for the new HABP PRO instrument, our previously developed Community-Acquired Bacterial Pneumonia (CABP) PRO instrument item pool was utilized given observed overlap of concepts between the two patient populations. Combined CE/cognitive debriefing (CD) interviews were then conducted with additional HABP patients to further explore the HABP disease experience and assess relevance and understanding of items, response options, instructions, and recall period of the new instrument. Data were analyzed using an iterative process to identify themes and concepts documented according to FDA PRO Guidance. RESULTS: Eighteen patients participated in CE (n=8) and combined CE/CD (n=10) interviews. Mean age of the sample was 62 years (SD = 12, range: 41-84); 50% were male. Similar to CABP, the most common spontaneously reported symptoms among HABP patients were difficulty breathing (72%), cough (56%), chest pain (56%), fever (50%), and lack of energy (50%). Significant impacts on physical (72%) and emotional (67%) functioning were also reported. Analysis of CD data indicated all 10 patients interpreted the large majority of items on the HABP PRO as intended, and reported the concepts covered were comprehensive and relevant to their illness. CONCLUSIONS: Results support the content validity of the HABP PRO items within a HABP population. Future research will assess the measurement properties of this new instrument.