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Psychometric evaluation of the NFOSI-18 disease related symptoms - Physical, NFOSI-18 Total, and FACT GP5 in the
Xiaodan Tang1, Helen Huang2, John D Peipert3
1Northwestern University, Chicago, IL, United States of America.
Background:
Patient-reported outcomes (PROs) are critical in recurrent ovarian cancer, where symptom burden and quality of life (QOL) influence treatment decisions. Given limited psychometric validation of PROs in patients receiving modern targeted therapies, we conducted a comprehensive evaluation of the NCCN/FACT Ovarian Symptom Index-18 (NFOSI-18), including both Total and disease-related symptoms (DRS-P) subscale scores, and a single-item about side effect (GP5), to assess their reliability and validity in recurrent ovarian cancer.
Methods:
Data were drawn from NRG Oncology trial GY004 (n = 489). Participants completed the NFOSI-18, EQ-5D-3L and EQ-VAS at baseline and every 12 weeks. Baseline and last QOL time points were analyzed to evaluate psychometric properties of the NFOSI-18 DRS-P and Total scores, and the GP5 item. Analyses included internal consistency reliability, convergent and known-groups validity, responsiveness to change, and meaningful change thresholds.
Results:
The DRS-P and Total scales demonstrated good internal consistency (Cronbach's α = 0.72-0.87) and moderate convergent validity with EQ-5D VAS and Utility Index (r = 0.56-0.63). Strong known-groups validity was observed, with moderate-to-large effect sizes (0.44-1.05) across performance status categories. Score declines were greater in patients with stable or progressive disease compared to those with complete or partial response, supporting responsiveness to clinically meaningful change. Recommended change thresholds were 4-12 points (Total) and 3-8 points (DRS-P).
Conclusions:
The NFOSI-18 DRS-P and Total scales are reliable, valid, and responsive measures in recurrent ovarian cancer. These findings support their use as PRO endpoints in future ovarian cancer clinical trials.
