Analyses
insomnia, Pain
APPETITE LOSS
Measurement properties of the PRO tools were evaluated by using measurements at baseline, cycle 4, and cycle 7 from the DeFi study. The blinded data were pooled across treatment arms for these validation analyses. Baseline demographic and clinical variables were described using descriptive statistics (e.g., mean, standard deviation (SD), median) for quantitative variables, and percentage and frequency for categorical variables.Completion rate from baseline was calculated as the number of patients expected at each timepoint (excluding subject discontinuations) divided by the number of patients still on trial at the analysis timepoint. A summary DTSS score over a week was defined as the average of the daily diary score over the 7-day period if the patient completed ≥ 4 of 7 days, otherwise the score was considered missing.Inter-item correlations at baseline were assessed using Spearman and polychoric correlation coefficients for the 11-point NRS item pairs and the 5-point Likert scale items, respectively. Values > 0.4 provided support for combining items into a multi-item scale, whereas pairs of items with coefficients > 0.9 and/or < 0.3 were considered for further scrutiny when developing the scoring algorithm [Internal consistency reliability, reflecting the degree to which a set of items in the same scale co-vary, was assessed at baseline, cycles 4 and 7 using Cronbach’s alpha coefficients with 95% confidence intervals (CIs); values ≥ 0.70 are considered to represent acceptable reliability [Construct validity was assessed by examining convergent and known-groups validity. Convergent validity, referring to how well constructs that theoretically should be related to each other are observed to be related, was evaluated at baseline by correlation coefficients between DTSS and DTIS and concepts captured from other PRO instruments (i.e., DTSS and BPI-SF Pain Severity items and overall Pain Severity scale, PROMIS-PF short-form 10a score, EORTC QLQ-C30 Global Health Status, symptom scales, and appetite loss; DTIS and BPI-SF Interference scale, 3 PROMIS items, EORTC QLQ-C30 functional scales and insomnia). Correlation coefficients ≥ 0.40 are considered evidence of convergent validity [