Table 3.
Quality of life assessment of people enrolled in randomized trials comparing mesalazine with control interventions for diverticular disease.
| Study, year (reference) | Quality-of-life instrument | Validation of the instrument | Time of assessment | Method of Reporting | Domains reported | Results |
|---|---|---|---|---|---|---|
| Comparato et al., 2007a [24] | Medical Outcome Study (MOS) 36-Item Short-Form Health Survey (SF-36, Italian version 1.6) questionnaire | Yesa | Baseline and 6 months | Mean change of each domain score between baseline and 6 months in the mesalazine and rifaximin group. Difference of the mean scores of each domain at baseline and 6 months between the two groups. |
Physical health: | In the mesalazine group there was a significant improvement of physical functioning (p=0.05), role limitation-physical (p=0.034), general health (p=0.01), and social functioning (p<0.01) at 6 months. In the rifaximin group there was a significant improvement of role limitation-physical (p=0.04) and social functioning (p=0.03) at 6 months. There was no statistically significant difference of SF-36 mean scores between the two groups at baseline. There was a higher improvement of physical functioning (p<0.05) and general health (p=0.01) in the mesalazine than rifaximin group at 6 months. |
| Physical functioning | ||||||
| Role limitation-physical | ||||||
| Bodily | ||||||
| pain | ||||||
| General health | ||||||
| Mental health: | ||||||
| Role limitation-emotional | ||||||
| Vitality | ||||||
| Mental health | ||||||
| Social functioning | ||||||
| Parente et al., 2013 [28] | Therapy Impact Questionnaire (TIQ), quality-of-life sub-scoreb | No | Baseline and every 3 months until 24 months | Difference of the mean quality-of-life sub-scores at baseline and 24 months between mesalazine and placebo group. | Sleeping problem Physical status interfering with sexual activity Problem in out-door activities Problem in social activities Problem in in-house activities different from house works Problem in daily work activities Problem in free-time activities |
There was no statistically significant difference of the total quality-of-life sub-score between the mesalazine and placebo group at baseline and 24 months. |
| PREVENT1, 2014 [31] | (1) EuroQol five dimensions questionnaire (EQ-5D) (2) Health Utilities Index Version Mark 2 (HUI2) questionnaire |
Yesa | Baseline and 16, 52, 78, 104 weeks | Difference of the total EQ-5D and HUI2 scores at baseline and 104 weeks across study arms (mesalazine 1200mg, mesalazine 2400mg, mesalazine 4800mg, placebo). | EQ-5D questionnaire: | There was no statistically significant difference of the total EQ-5D and HUI2 scores at baseline and 104 weeks across study arms. |
| Mobility | ||||||
| Self-care | ||||||
| Usual activities | ||||||
| Pain/discomfort | ||||||
| Anxiety/depression | ||||||
| HUI2 questionnaire: | ||||||
| Sensation | ||||||
| Cognition | ||||||
| Mobility | ||||||
| Self-care | ||||||
| Emotion | ||||||
| Pain | ||||||
| Fertility | ||||||
| PREVENT2, 2014 [31] | (1) EuroQol five dimensions questionnaire (EQ-5D) (2) Health Utilities Index Version Mark 2 (HUI2) questionnaire |
Yesa | Baseline and 16, 52, 78, 104 weeks | Difference of the total EQ-5D and HUI2 scores at baseline and 104 weeks across study arms (mesalazine 1200mg, mesalazine 2400mg, mesalazine 4800mg, placebo). | EQ-5D questionnaire: | There was no statistically significant difference of the total EQ-5D and HUI2 scores at baseline and 104 weeks across study arms. |
| Mobility | ||||||
| Self-care | ||||||
| Usual activities | ||||||
| Pain/discomfort | ||||||
| Anxiety/depression | ||||||
| HUI2 questionnaire: | ||||||
| Sensation | ||||||
| Cognition | ||||||
| Mobility | ||||||
| Self-care | ||||||
| Emotion | ||||||
| Pain | ||||||
| Fertility |
EQ-5D, EuroQol five dimensions; HUI2, Health Utilities Index Version Mark 2.
aInstrument validated to measure generic health outcomes in all therapeutic areas.
b11-item questionnaire: the sum of items 1-4 defines the physical condition subscore, while the sum of items 5-11 defines the quality-of-life subscore.