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Table 1 Aspects relevant to HRQoL statistical analysis

From: Methodology of health-related quality of life analysis in phase III advanced non-small-cell lung cancer clinical trials: a critical review

First authors HRQoL questionnaire Timing of assessment Targeted dimensions MCID Statistical approach for dealing with missing data Statistical approach for HRQoL analysis
Wu [19] QLQ-C30; QLQ-LC13 Randomization and every 3 weeks until disease progression or new cancer treatment Cough, dyspnoea, pain 10 points   Distribution of patients whose symptom had improved, remained stable, or worsened; the time to deterioration of symptoms; mixed-effects growth curve model
Laurie [20] QLQ-C30; QLQ-LC13 and two additional questions (hand-foot syndrome and headache) At baseline and every cycle     
Yang [7] QLQ-C30; QLQ-LC13 Random assignment and every 21 days until disease progression Cough, dyspnoea, pain 10 Joint analysis Time to deterioration; mixed-effects growth curve model
Wu [19] FACT-L Not available FACT-L total score and TOI    Time to deterioration
Yoshioka [21] FACT-L; FACT/GOGNTX At the time of enrollment and at 6 and 9 weeks after the initiation of treatment     Linear mixed model for repeated measures
Lee [22] QLQ-C30, QLQ-LC14, EUROQOL Baseline, monthly during the first year, then 18 and 24 months after randomization     Linear mixed model for repeated measures
Gridelli [23]       
Flotten [24] QLQ-C30, QLQ-LC13 Before each cycle, 3 weeks after the last cycle, and then every 8 weeks until 57 weeks Global health status health, nausea/vomiting, dyspnoea, fatigue 10   Mean change from baseline
Socinsky [25] FACT-G, FACTTAXANE Baseline and on day 1 of each cycle Peripheral neuropathy, pain, hearing, edema    Mean change from baseline
Groen [26] QLQ-C30, QLQ-LC13 Start of chemotherapy and weeks 6,12,16,24,30     Mean change from baseline
Chen [9] FACT-L Baseline and every 6 weeks   6 for FACT-L total score and TOI; 2 points for LCS LCS   Mean change from baseline
Lara [27] QLQ-C30 On day 1 of each odd cycle and at the end of the treatment visit     Mean change from baseline
Koch [12] QLQ-C30, QLQ-LC13 Baseline, weeks 3,6,9,12,20,28 Dyspnoea, fatigue, pain, pain medication, global health status    Group comparisons of scale at each time; mean change from baseline; AUC; rates of symptom palliation
Biesma [28] QLQ-C30, QLQ-LC13 Before, during (day 1 and day 8 of each cycle) and after each cycle (weeks 12,15,18) Global health status 10   Mean change from baseline and week 18; linear mixed model for repeated measures
Weissman [29] FACT-L After each cycle TOI    Mean change from baseline and after 6 cycles
Okamoto [30] FACT-L, FACT/GOGNTX Time of enrollment and at 6 and 9 weeks after initiation of treatment     Linear mixed model for repeated measures
Thongpraset [31] FACT-L Baseline, weeks 1 AND 3, 3-weekly until week 18, 6 weekly until progression and at discontinuation FACT-L Score, TOI, LCS 6 for FACT-L total score and TOI; 2 points for LCS If less than 50% of the Fact-l subscale scores were missing, the subscale score was divided by the number of completed items and multiplied by the total number of items on the scale. If 50% or more of the items were missing, that subscale was treated as missing for that patient Mean change from baseline; Time to worsening; Time to improvement
Lynch [32] FACT-L Baseline, before each treatment cycle and at the end of the therapy     Mean change from baseline; Time to symptomatic disease progression
Takeda [33] FACT-L The time of enrollment and at 12 weeks, 18 weeks after initiation of treatment LCS   Linear mixed-effects model in which the missing data depend on the observed score Linear mixed model for repeated measures
Lee [34] QLQ-C30, QLQ-LC14 Random, During each cycle, at the end of the chemotherapy, every 6 months until 24 months     Linear mixed model for repeated measures
Treat [35] FACT-L Not available     
Tan [36] Lung cancer symptom scale Baseline, at the end of each cycle, just before the next cycle, at the end of the study     
Pirker [37] QLQ-C30, QLQ-LC13, EuroQoL EQ-5D Not available     
Gronberg [38] QLQ-C30, QLQ-LC13 Weeks 0,3,6,9,12,20,28,36,44,52 Global health status health, nausea/vomiting, dyspnoea, fatigue 10 Last value carried forward for missing value that followed, even after death Area under the curve
O’Brien [39] FACT-L Baseline, before each cycle and at the end of the treatment LCS 2 Missing scores at week 3 were classified as having less than a 2-point increase in the primary analysis data but classified as missing and excluded from the supplemental analysis Fisher test for equal proportion of patients achieving at least two points increase
Langer [40] FACT-L Baseline and within 3 days of each treatment LCS 2   Percentage of patients with at least two points improvement at the beginning of cycle 2
Gebbia [41] QLQ-C30; QLQ-LC13 Baseline and every cycle     
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