Abstract
Objective: To evaluate psychometric performance of the NCCN-FACT Ovarian Cancer Symptom Index-18 (NFOSI-18) in advanced ovarian cancer. Methods: Cross-sectional, observational data from patients receiving treatment for ovarian cancer. Other measures included European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core (EORTC QLQ-C30) and associated ovarian cancer module (EORTC QLQ-OV28) and Work Productivity and Activity Impairment. Internal consistency reliability, construct validity and anchor-based clinically important differences were assessed. Results: 897 patients were analyzed. Reliability was acceptable for all NFOSI-18 scores; construct validity was supported. Twelve anchors sufficiently correlated with NFOSI-18 scores and suggested clinically important differences: NFOSI-18 total score (5-7), disease-related symptoms - physical (3-4), disease-related symptoms - emotional (1), treatment side effects (2) and functional well-being (1-2). Conclusions: Results provide evidence of reliability and validity of NFOSI-18 scores. Generated CIDs will help improve interpretation of between-group treatment differences in clinical trials.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 3951-3964 |
| Number of pages | 14 |
| Journal | Future Oncology |
| Volume | 17 |
| Issue number | 30 |
| DOIs | |
| State | Published - Oct 2021 |
Funding
This trial was sponsored by Pfizer and is part of an alliance between Pfizer and Merck KGaA, Darmstadt, Germany. A Trigg, M Kelly, A Moreno-Koehler, A Yaworsky and K Cocks are employees of Adelphi Values. M Krohe was employed by Adelphi Values at the time the work was undertaken. Adelphi Values conducted the analyses conducted as part of this study. A Rider is an employee of Adelphi Real World. Adelphi Real World conducted the ovarian cancer DSP capturing the real-world evidence for the analyses conducted as part of this study. Adelphi were paid consultants to Pfizer in connection with the development of this manuscript. L Iadeluca, J Chang and JC Cappelleri are employees of Pfizer. D Cella is the President of FACIT.org and was a paid consultant to Pfizer for this research. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.
Keywords
- Clinically important difference
- Interpretation
- NFOSI-18
- Ovarian cancer
- Patient-reported outcomes
- Psychometric properties
ASJC Scopus subject areas
- Oncology
- Cancer Research
