BackgroundThe EORTC QLQ-LC13 assesses quality of life (QoL) in patients with lung cancer (LC) and was the first EORTC module developed for use in international clinical trials. Since its publication in 1994, major treatment advances have occurred. This calls for an update of the module to improve the assessment and management of side effects, symptom burden, and quality of life. The paper presents results from the international psychometric validation study of the updated module. MethodsThis was an international, observational field study to investigate the psychometric properties of the updated LC-module. Psychometric analyses included confirmatory factor analysis and methods from classical test theory. Findings 523 patients with confirmed diagnosis of lung cancer (either NSCLC or SCLC; 270 [51•6%] NSCLC IV, 315 [60•2%] male, Karnofksy Performance Status median 80 [IQR = 20]) from 19 centers in 12 countries participated. The updated module consists of 29 items, keeping 12 from the previous QLQ-LC13. Confirmatory factor analysis suggested five multi-item scales (Coughing, Shortness of breath, Fear of progression, Hair problems, Surgery-related symptoms ) and 15 single items: RMSEA = 0•075, GFI = 0•934, NFI = 0•877, CFI = 0•901.Analyses of convergent and divergent validity confirmed this solution. Internal consistencies of all multi-item scales ranged between 0•73 and 0•86. Test-retest reliabilities ranged between 0•82 and 0•97. Four of the five multi-item scales yielded known group differences when patients with lower vs. higher Karnofsky Performance Status were contrasted (p < 0•007); so did 10 of the 15 single items. Three of the five multi-item scales showed responsiveness to change over time (p < 0•050); so did 9 out of 15 single symptoms. InterpretationThe Phase 4 study determined the psychometric properties of the updated LC module, which is ready for use in international clinical lung cancer studies.

significant reduction in left atrial (LA) (p=0.001) and LV enddiastolic M-mode dimensions (p=0.001) and volumes (p=0.006), with no change in LV end-systolic volumes, yielding a significant reduction in LV functional measures (fractional shortening (34.5 vs 31.5%, p=0.006), fourchamber ejection fraction (62.6 vs 51.7%, p=0.002) and LV longitudinal strain (-24.3 vs-18.2%, p,0.001). Compared to controls, LA and LV dimensions remained increased with a reduction in all functional parameters after repair. There was a moderate negative correlation between preoperative enddiastolic volumes and postoperative longitudinal strain (r 2 =0.35). Discussion: Persistent LV and LA remodelling with decreased LV function is observed after repair of RHD-MR. While these results reflect changes to volume loading, the unmasking of decreased LV function and persistent remodelling; and linear relation to preoperative LV size, may suggest that early intervention to alleviate MR could benefit selected patients and warrants further study.

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