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Open Access 01-12-2019 | Constipation | Research

Further content validation of the 18-item NCCN/FACT Ovarian Symptom Index and its Disease Related Symptom-Physical (DRS-P) subscale for use in advanced ovarian cancer clinical trials

Authors: Sara Shaunfield, Sally Jensen, Allison P. Fisher, Kimberly Webster, Shohreh Shahabi, Arijit Ganguli, David Cella

Published in: Health and Quality of Life Outcomes | Issue 1/2019

Abstract

Background

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.

Methods

Twenty-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.

Results

Pain 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.”

Conclusions

Findings 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.

Participants were able to choose all options that apply. Therefore, a participant did not have to choose between treatment- and disease-related factors and could endorse both.

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Title: Further content validation of the 18-item NCCN/FACT Ovarian Symptom Index and its Disease Related Symptom-Physical (DRS-P) subscale for use in advanced ovarian cancer clinical trials
Authors: Sara Shaunfield
Sally Jensen
Allison P. Fisher
Kimberly Webster
Shohreh Shahabi
Arijit Ganguli
David Cella
Publication date: 01-12-2019
Publisher: BioMed Central
Keywords: Constipation
Ovarian Cancer
Ovarian Cancer
Constipation
Fatigue
Published in: Health and Quality of Life Outcomes / Issue 1/2019
Electronic ISSN: 1477-7525
DOI: https://doi.org/10.1186/s12955-019-1253-3

At a glance: The STEP trials

Springer Medicine

Further content validation of the 18-item NCCN/FACT Ovarian Symptom Index and its Disease Related Symptom-Physical (DRS-P) subscale for use in advanced ovarian cancer clinical trials

Abstract

Background

Methods

Results

Conclusions

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

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