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. 2019 Apr 16;19:361. doi: 10.1186/s12885-019-5579-3

Table 2.

Aspects relevant to HRQoL statistical analysis

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

FACT-HN Functional Assessment of Cancer Therapy Head and neck, SF-36 Short form of the medical outcomes study, FACT-B Functional Assessment of Cancer Therapy Breast, QLQ-C30 European Organization for Research and Treatment of Cancer Core Quality of life Questionnaire, FACT-L Functional Assessment of Cancer Therapy Lung, SF-12 Short Form-12 Health, BDI-SF Beck Depression Inventory Short-Form, FSFI Female Sexual Function Index, IIEF International Index of Erectile Function, PHQ-9 Patient Health Questionnaire, GAD-7 Generalized Anxiety Disorder 7-item, IPSS International Prostate Symptom Score, UCLA-PCI-SF Bowel habits domain of University of California, Los Angeles Prostate Cancer Index-Short from