Abstract
BackgroundThis study evaluated pre-defined aspects of content validity of the 18-item NCCN FACT-Ovarian Symptom Index (NFOSI-18) and its Disease-Related Symptoms-Physical (DRS-P) subscale, as clinical trial outcome tools for patients with advanced ovarian cancer.MethodsTwenty-one women (mean age 59.5 years) diagnosed with advanced ovarian cancer completed the NFOSI-18 and participated in a cognitive interview to explore: (1) whether ‘pain’ and ‘cramps’ are considered redundant; (2) whether ‘fatigue’ and ‘lack of energy’ are overlapping concepts; (3) whether patients consider severity when responding to the item “I am bothered by constipation;” and (4) factors considered when responding to the item “I am sleeping well.” Interviews were audio-recorded, transcribed, and analyzed qualitatively.ResultsPain was associated with discomfort, hurt, and life interference; ‘cramps’ was associated with pain, muscle tightening, and menstrual or digestive issues. Most (81%) considered the items “I have pain” and “I have cramps in my stomach area” to be more different than similar. Participants associated ‘fatigue’ with intense tiredness and ‘lack of energy’ with motivation and capability to complete daily activities. Item comparisons revealed a majority (65%) considered the items to be more different than similar. When responding to “I am bothered by constipation,” patients indicated constipation severity was related to bother. Finally, patients considered disease, treatment, and other factors when responding to “I am sleeping well.”ConclusionsFindings support content validity of the NFOSI-18 and its DRS-P as originally constructed. We propose an alternative scoring option that excludes the item “I am sleeping well” from the DRS-P when used as a symptom-focused index for clinical research in a regulatory context.
Highlights
Ovarian cancer represents the second most common and deadliest gynecologic cancer [1]
We explored the following four specific questions: (1) Do patients consider ‘pain’ and ‘cramps’ to be redundant concepts?; (2) Are ‘fatigue’ and ‘lack of energy’ overlapping concepts?; (3) Does the item “I am bothered by constipation” assess severity?; (4) What factors do patients consider when responding to: “I am sleeping well?”
This study provides further evidence for the validity of the NFOSI-18 and its 9-item Disease-Related Symptoms-Physical (DRS-P) for use in clinical research within a regulatory context
Summary
Ovarian cancer represents the second most common and deadliest gynecologic cancer [1]. The limited options for cure among women with advanced disease, coupled with the treatment and disease burden they face, highlights the significance of QOL as an important clinical and research outcome. The NCCN-FACT Ovarian Symptom Index-18 (NFOSI18) was developed to provide a clinically meaningful patientreported symptom index reflecting the symptoms and concerns identified as most important by women with advanced ovarian cancer [3, 4]. Four subscales comprise the 18item index: disease-related symptoms-physical (DRS-P; 9 items), disease-related symptoms-emotional (1 item), treatment side effects (5 items), and general function/well-being (3 items). This study evaluated pre-defined aspects of content validity of the 18-item NCCN FACT-Ovarian Symptom Index (NFOSI-18) and its Disease-Related Symptoms-Physical (DRS-P) subscale, as clinical trial outcome tools for patients with advanced ovarian cancer
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