Development of the patient-reported outcome item set for ovarian cancer patients receiving PARP inhibitor therapy

Ovarian cancer patients may experience a severe treatment-related symptomatic burden during Poly (ADP-ribose) polymerase inhibitor therapy. This study aimed to develop a set of patient-reported outcome (PRO) items and investigate its preliminary content validity for monitoring adverse events in ovarian cancer patients during PARP inhibitor therapy. Based on a literature review and prescribing information analysis, 15 symptomatic adverse events were preliminarily identified. To validate the content, the item set was applied to a prospective pilot study that evaluated the symptom burden of 15 ovarian cancer patients receiving PARP inhibitor therapy. The severity of symptoms was assessed using a numerical rating scale (NRS), with 10 indicating the most severe symptoms and 0 indicating no symptoms at all. Symptoms that were reported by ≥ 20% of patients or had a score of ≥ 4 were included in the final item set. After re-screening from the prospective pilot study and subsequent clinical expert item assessments, 13 symptom items were ultimately selected for symptom monitoring during PARP inhibitors therapy in ovarian cancer patients, providing a basis for quantifying patient experience during PARP inhibitor treatment. Clinical trial registration : ChiCTR2400085888.