title: Validation of the functional assessment of cancer therapy--lung symptom index-12 (FLSI-12).
abstract: We tested the reliability and validity of a brief symptom index for use with patients in the advanced stages of lung cancer. The Functional Assessment of Cancer Therapy--Lung Symptom Index-12 (FLSI-12) is a brief self-report measure that combines seven items addressing symptoms common in advanced-stage lung cancer with five symptoms or concerns that are relevant to most people with advanced-stage cancer. The index was administered prospectively to 92 advanced-stage lung cancer patients beginning at the initiation of chemotherapy and for 12 consecutive weeks. Reliability, convergent and concurrent validities, and responsiveness to change were determined and a minimally important difference (MID) was estimated. The index had good internal consistency (all Cronbach's alpha's>0.70), moderate to high item-to-total correlations (93% rho's> or =0.30), and correlated highly with a measure of overall quality of life (rho's> or =0.50). Baseline scores differentiated patients with better versus worse clinical features (p's<.05). Prospective changes in index scores were sensitive to changes in performance status ratings (p's<.05). An MID of 3-4 points was estimated by combining guideline-, distribution-, and anchor-based methods. The results show that the FLSI-12 is a psychometrically sound measure and support its use as an endpoint in clinical trials of advanced-stage lung cancer.
authors.affiliation: Center on Outcomes, Research and Education, Evanston Northwestern Healthcare Research Institute, 1001 University Place, Suite 100, Evanston, IL 60201, USA. d-eton@northwestern.edu
authors.forename: David T
authors.initials: DT
authors.lastname: Eton
authors.forename: David
authors.initials: D
authors.lastname: Cella
authors.forename: Susan E
authors.initials: SE
authors.lastname: Yount
authors.forename: Kimberly M
authors.initials: KM
authors.lastname: Davis
mesh_terms: D000368:Aged; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011594:Psychometrics / Q000379:methods*; D015203:Reproducibility of Results; D012720:Severity of Illness Index