Table 2 Aspects relevant to HRQoL statistical analysis
From: Health-related quality of life as an endpoint in oncology phase I trials: a systematic review
First author | HRQoL questionnaire | Timing of assessment | Targeted dimensions | MCID | Statistical approach for HRQoL analysis | QoL data interpretation |
|---|---|---|---|---|---|---|
Ringash [8] | FACT-HN | Baseline, 6 and 12 months after completion of radiotherapy | Mean change at 6 months, mean change at 12 months, linear mixed model for repeated measure | Better through time in all groups and no relationship with dose level of radiation | ||
Crew [14] | SF-36 | Baseline and 6 months | Finally, no significant change in quality of life as assessed by the SF-36 was observed in either treatment group | |||
Xiao [15] | Mean change from baseline | Not reported | ||||
Lin [16] | FACT-B | Baseline, 6 and 12 months | Mean change from baseline | No comparison between the different tested doses (data missing because of death or withdrawal. « Quality of life according to the FACT-Br was generally worse at 6 months for women on study. However, the interpretations of these data are limited by the small number of women with results at both time points and because over half of patients had progressed by that time. » | ||
Kanai [17] | QLQ-C30 | Each cycle | Baseline vs best score during treatment intake | No comparison between the dose groups. « Since improved QOL has been demonstrated to contribute to a better outcome in cancer patients it is tempting to speculate that Theracurmin® can improve the outcome of cancer patients through an improvement in QOL. » | ||
Tsubata [9] | FACT-L | Every 4 weeks until 12 weeks after the start of treatment | Mean score at 12 weeks | No differences observed between the treatment doses. « The overall response rate was 1/8, toxicity was acceptable and the QOL score was good. This regimen is therefore suitable for use in elderly patients with NSCLC in an outpatient setting. » | ||
Han [18] | After treatment cycles 1 and 2 | Percentage | No treatment effect. « Significantly fewer patients preferred Ca/Mg infusions for reducing their neurotoxicity symptoms than those who preferred placebo or neither treatment (26% versus 74%; P = 0.01). » | |||
Rouanne [19] | SF-12, BDI-SF, FSFI, IIEF | Baseline, 1 month | Mean change from baseline | « The patients scored statistically significant decrease in physical health component on the SF-12 after 1-month treatment whereas mental component scale scores did not differ significantly. » | ||
Stephenson [20] | QLQ-C30 | Baseline and prior each infusion of vitamin C | Mean score at each cycle | Not used in the discussion. | ||
Hunn [21] | QLQ-C30 | Not used in the discussion. | ||||
Reiss [22] | QLQ-C30 | Baseline and every 2 cycles | 10 points | Mean change from baseline | Extensive interpretation. « Our regimen was well tolerated by measures of toxicity and by our QoL data. » « Those who discontinued therapy early, either due to progression of disease, adverse effects, or a global inability to tolerate further treatment, may have had inferior QoL while on this regimen as compared with those who were able to continue the regimen. « | |
Cusi [23] | Mean change from baseline | Not used in the discussion. | ||||
McRee [24] | PHQ-9, GAD-7 | Not reported | ||||
Chin [25] | IPSS, IIEF-15, UCLA-PCI-SF | Mean change from baseline | « Functional outcomes, IPSS and IIEF-15, both showed a favorable anticipated trend of initial deterioration with subsequent gradual improvement toward baseline levels. » | |||
Anota [11] | QLQ-C30 | Baseline and at days 15, 30 and 60 after chemoembolisation | Global health status, physical functioning, fatigue and pain | 5 points | Time to deterioration | Overall, patients included at the 10 mg idarubicin dose level seemed to have a longer TTD of HRQoL than patients included at the 5 mg or 15 mg idarubicin dose levels. HRQoL results are thus consistent with the 10 mg idarubicin dose level selected as the MTD |