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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