The self-administered FACIT-CCSQ consists of 15 qualitative items relating to the patient’s sellckchem experience of chemotherapy and treatment without time limitations (except one past week time-framed item) and eight items (quantitative criteria) relating to the patient’s use of health-care resources during the previous cycle. Most of the qualitative items were organised into three subscales related to chemotherapy convenience, concerns and satisfaction. Each scale and item was transformed into a scale ranging from 0 to 100. The FACIT-CCSQ was translated into the French language according to the FACIT procedure. MID The minimally important difference (MID) is defined as the smallest difference in score in the domain of interest that patients perceive as important, either beneficial or harmful, and that would lead the clinician to consider a change in the patient’s management (Guyatt et al, 2002; Yost et al, 2005b).
Considering the QLQ-C30, an MID of more than 10 points from baseline to a subsequent visit could be considered as being clinically significant (Osoba et al, 1998). Considering the FACIT-CCSQ, the MID was fixed at 6�C9 points for convenience, 7�C10 points for concerns and 5�C9 points for satisfaction subscales (Yost et al, 2005a). Statistical methods The ITT population included all randomised patients meeting the inclusion criteria. Two HRQoL sets were considered: QLQ-C30 set: defined as all ITT patients having an assessable QLQ-C30 (<50% of missing responses) at baseline, FACIT-CCSQ set: defined as all ITT patients having an assessable FACIT-CCSQ (<50% of missing responses) at baseline.
The number of required patients in the study was based on the demonstration of non-inferiority in terms of efficacy between the XELOX and FOLFOX-6 arms. The total number of patients needed for randomisation in the per-protocol population was defined as 137 persons per group. When considering that 10% of patients could be excluded from the study, an ITT population of (137 �� 2)/0.9=304 patients was required. The same number of patients was considered for the secondary objectives, including QoL and satisfaction assessments. Efficacy and safety assessments, as well as health economic results, are presented in detail in separate papers (Perrocheau et al, 2009; Ducreux et al, 2007).
At each assessment time, the 15 scales of the QLQ-C30 Cilengitide were computed and analysed in the QLQ-C30 set, whereas the items of the FACIT-CCSQ were analysed in the FACIT-CCSQ set. For both questionnaires, missing items were estimated according to their respective scoring manuals when feasible (Fayers et al, 2001; www.facit.org). For each item of both questionnaires, the baseline value and values at subsequent visits were provided for each study arm using descriptive statistics. The differences between arms were tested with an analysis of variance test.