From: A review of the psychometric performance of the EQ-5D in people with urinary incontinence
Author(s), Year | Comparison | Change in clinical measure(s) or other preference based utility | Change in EQ-5D | Agreement with direction? | Agreement with statistical significance? |
---|---|---|---|---|---|
Ismail et al, 2009 [16] | Change over time | No significant change on any measure (KHQ,1 hr pad test, pad use, leakage episodes) | No significant change | NA | Yes |
Rinnie et al, 2008 [22] | Change over time | 24 hr pad test significantly improved in both arms | Significant improvement in both arms | Yes | Yes |
All condition specific measures (UISS, DIS, VAS, IIQ-7, UDI-6) significantly improved in both treatment groups | |||||
EQ-VAS significantly improved in both treatment groups | |||||
Difference between treatment arms | No significant difference in objective cure, leakage, complication rate, UISS, DIS, VAS, IIQ-7, UDI-6. | No significant difference in EQ-5D | Agreement with some clinical outcomes and not others. | Yes | |
Haywood et al 2008 [7] | Comparison of means for responders and non-responders | 6 week data: | 6 week data: | 6 week data: | 6 week data: |
SSI and I-QoL index had difference in expected direction but not statistically significant (at p=0.01). Two of the I-QoL domains had significant difference. | EQ-5D had difference in expected direction but not statistically significant (at p=0.01). | Yes | Not consistent with all | ||
5 mth data: | 5 mth data: | 5 mth data: | 5 mth data: | ||
As for 6 weeks except only one of the I-QoL domains had significant (p<0.01) difference. | EQ-5D had difference in expected direction and statistically significant (p=0.01). | Yes | Not consistent with all. | ||
Mean change scores for patients reporting improvement | 6 week data: | 6 week data: | 6 week data: | 6 week data: | |
Expected direction and significant (at p=0.05) for SSI, I-QoL index, I-QoL domains | Expected direction but p>0.05 | Yes | No | ||
5 mth data: | 5 mth data: | 5 mth data: | 5 mth data: | ||
As for 6 weeks but larger changes. | Expected direction and p<0.05. | Yes | Yes | ||
MSRM for patients reporting improvement | 6 week data: | 6 week data: | 6 week data: | 6 week data: | |
SSI, 0.70 | 0.07 | Yes | No | ||
I-QoL index, 1.01 | |||||
I-Qol domains, 0.40 to 0.94 | |||||
5 mth data: | 5 mth data: | 5 mth data: | 5 mth data: | ||
SSI, 0.67 | 0.26 | Yes | Yes | ||
I-QoL index, 1.17 | |||||
I-Qol domains, 0.80 to 1.25 | |||||
Kobelt et al, 2006 [21] | Median incontinence episodes per day for clinical outcome but change from baseline for EQ-5D | All patients: | All patients: | All patients | All patients |
3.0 at baseline, 0.7 at 3mths and 0.9 at 12 mths (p<0.0001 and p<0.001 for differences) | 3 mths: 0.048 (p<0.001)6 mths: 0.014 (not significant) | 3 mths: Yes | 3 mths: Yes | ||
12 mths: “gain remained evident” | 12 mths: Yes | 12 mths: Yes | |||
Patients with utility<1 at baseline: | Patients with utility <1 at baseline: | Patients with utility <1 at baseline: | |||
3 mths: 0.099 (p<0.01) | |||||
6 mths: 0.065 (p<0.001) | |||||
12 mths: “significant improvements” | As for all patients | As for all patients | |||
Dumville et al, 2006 [17] | Difference between treatment arms: | Objective and subjective cure rates and SF-36 scores showed no significant difference | QALY gain based on EQ-5D utility scores showed no significant difference (CrI crossed zero) | No change in either clinical, generic HRQoL or utility | Yes |
Manca et al, 2003 [18] | Differences from baseline to 6mths | Pad weight decreased significantly for both groups. | Utility increased in both arms (significance not reported) | Yes | Not reported |
Significant reduction in leakage episodes in both groups (P<0.0001) | |||||
Significant reduction in 21/30 symptoms (BFLUTS) in both groups (P<0.0001) | |||||
Differences between trial arms: | No significant difference in objective or subjective cure rate between trial arms | QALY difference between arms based on EQ-5D scores non significant at p=0.05 | Agreement with clinical outcomes but didn’t detect differences between arms in some SF-36 domains | Yes for clinical outcomes, no for some SF-36 domains | |
SF-36 scores had significantly smaller improvement/ greater decline lower for colposuspension group vs TVT in four domains at 6 weeks and four domains (three same and one different) at 6 mths. | |||||
Noble et al, 2002 [11] | Change from baseline: | Improvements in I-PSS, maximum urine flow, and residual volume were significant (p=0.05) for laser and resection but not conservative. | Means increased for laser and resection but not conservative (p values not reported) | Yes | Not reported |
Improvements in I-PSS QoL were significant for all three interventions. | |||||
Differences between trial arms: | Resection vs conservative and laser vs conservative showed significant difference in all four outcomes. | Gains were greater for resection than laser therapy (p values not reported) | Yes | Not reported | |
Laser vs resection showed significant difference in only one outcome which was in favour of resection (maximum flow) | |||||
Mihaylova et al, 2010 [23] | Comparison between active treatment arms and no treatment: | Number of leaks avoided per week was significantly (p<0.01) better for Duloxetine alone, conservative alone and duloxetine plus conservative (all relative to no treatment). | QALY gains based on EQ-5D utility were significant for Duloxetine alone (p<0.01) and duloxetine plus conservative treatment (p<0.05) but conservative alone was not significant and was negative (all compared to no treatment) | Yes for two of three comparisons against no treatment | Yes for two of three comparisons against no treatment |
Comparison between the three active treatment arms: | No significant reduction in number of leaks for 3 comparisons between active treatment arms. | Significant (p<0.05) QALY gains for 2 of 3 comparisons between active treatment arms. | Yes for 2 of 3 comparisons between active treatment arms. | No for 2 of 3 comparisons between active treatment arms. |