7. Patient‐reported outcomes.
| Study | HRQL | Intervention | Comparators | P value1 | ||||
| Measure | Description | A/R | Change of index | Description | A/R | Change of index | ||
| Brockow 2007b2 | Global rating of disease severity by patients. Mean change of score (standard deviation) baseline to end of treatment (maximum 6 weeks). | Salt bath + UVB | n.r./81 | 29.9 (24.7) | UVB only | n.r./83 | 12.4 (24.6) | n.r. |
| Brockow 2007b2 | " baseline to 3 months | Salt bath + UVB | n.r./81 | 32.2 (27.6) | UVB only | n.r./83 | 22.5 (25.5) | n.r. |
| Brockow 2007b2 | " baseline to 6 months | Salt bath + UVB | n.r./81 | 22.5 (27.9) | UVB only | n.r./83 | 24.3 (27.6) | n.r. |
| Brockow 2007b2 | Global rating of treatment effect by patients. Mean (standard deviation) score at end of treatment (maximum 6 weeks). | Salt bath + UVB | n.r./81 | 81.2 (19.2) | UVB only | n.r./83 | 64.5 (27.7) | n.r. |
| Brockow 2007b2 | Global rating of tolerability by patients. Mean (standard deviation) score at end of treatment (maximum 6 weeks). | Salt bath + UVB | n.r./81 | 87.4 (12.3) | UVB only | n.r./83 | 87.4 (12.3) | n.r. |
| Brockow 2007b2 | Self‐administered PASI (S‐PASI). Number of participants with reduction of S‐PASI by 50% or more (%) at end of treatment (maximum 6 weeks). | Salt bath + UVB | 77/81 | 45 (58) | UVB only | 61/83 | 24 (39) | 0.04 |
| Brockow 2007b2 | " at 3 months. | Salt bath + UVB | 72/81 | 40 (56) | UVB only | 54/83 | 24 (44) | 0.28 |
| Brockow 2007b2 | " at 6 months. | Salt bath + UVB | 67/81 | 30 (45) | UVB only | 46/83 | 24 (50) | 0.70 |
| Klein 2011 | Psoriasis disability index at eight weeks on session 35 | Salt bath + UVB | 144/1833 | ‐18.3% ((22.3 ‐ 27.3) / 27.3)5 | UVB only | 106/1844 | ‐15.2%% ((25.6 ‐ 30.2) / 30.2)5 |
n.r. |
| Klein 2011 | " at one month | Salt bath + UVB | n.r./183 | ‐26.1% ((20.2 ‐ 27.3) / 27.3)5 | UVB only | n.r./184 | ‐20.5%% ((24.0 ‐ 30.2) / 30.2)5 |
n.r. |
| Klein 2011 | " at six months | Salt bath + UVB | n.r./183 | ‐30.0% ((19.1 ‐ 27.3) / 27.3)5 | UVB only | n.r./184 | ‐23.5%% ((23.1 ‐ 30.2) / 30.2)5 |
n.r. |
| Klein 2011 | Sickness impact profile at eight weeks on session 35 | Salt bath + UVB | 144/183 | ‐19.0% ((4.7 ‐ 5.8) / 5.8)5 |
UVB only | 106/184 | ‐10.7% ((5.0 ‐ 5.6) / 5.6)5 |
n.r. |
| Klein 2011 | " at one month | Salt bath + UVB | n.r./183 | ‐20.7% ((4.6 ‐ 5.8) / 5.8)5 |
UVB only | n.r./184 | ‐8.9% ((5.1 ‐ 5.6) / 5.6)5 |
n.r. |
| Klein 2011 | " at six months | Salt bath + UVB | n.r./183 | ‐31.0% ((4.0 ‐ 5.8) / 5.8)5 |
UVB only | n.r./184 | ‐21.4% ((4.4 ‐ 5.6) / 5.6)5 |
n.r. |
| Klein 2011 | Improvement of physical complaints of Freiburg Life Quality Assessment on session 35 (eight weeks) | Salt bath + UVB | 144/183 | +16.7% ((2.8 ‐ 2.4) / 2.4) | UVB only | 106/184 | +8.3% ((2.6 ‐ 2.4) / 2.4) | <0.001 |
| Klein 2011 | Global health total of Freiburg Life Quality Assessment on session 35 (eight weeks) | Salt bath + UVB | 144/183 | +37.5% ((3.3 ‐ 2.4) / 2.4) | UVB only | 106/184 | +8.3% ((2.6 ‐ 2.4) / 2.4) | 0.007 |
| Klein 2011 | Global health skin only of Freiburg Life Quality Assessment on session 35 (eight weeks) | Salt bath + UVB | 144/183 | +100.0% ((4.8 ‐ 2.4) / 2.4) | UVB only | 106/184 | +54.2% ((3.7 ‐ 2.4) / 2.4) | 0.001 |
| Klein 2011 | Global impression of therapy: very good or good on session 35 (eight weeks) | Salt bath + UVB | 144/183 | 64.8% | UVB only | 106/184 | 32.8% | <0.001 |
| Klein 2011 | Global impression of therapy: very bad or bad on session 35 (eight weeks) | Salt bath + UVB | 144/183 | 5.3% | UVB only | 106/184 | 30.4% | <0.001 |
| Leaute‐Labreze 2001 | Quality of life index determined on a 10‐cm analog scale on day 21 (three weeks) | Salt bath + UVB | 24/24 | ‐60%6 | UVB only | 21/21 | ‐50%6 | n.r. |
| Schiener 20072 | Global rating of disease severity by patients. Mean change of score (standard deviation) baseline to 2, 4, and 6 weeks or to end of treatment (maximum 8 weeks). | Salt bath + UVB | 299/310 | 36.3 (26.4) | UVB only | 270/301 | 21.5 (26.3) | n.r. |
| Schiener 20072 | " | Salt bath + UVB | 299/310 | 36.3 (26.4) | Tap water + UVB | 285/301 | 28.1 (29.9) | n.r. |
| Schiener 20072 | " | Salt bath + UVB | 299/310 | 36.3 (26.4) | Psoralen bath + UVA | 305/321 | 43.2 (27.5) | n.r. |
| Schiener 20072 | Global rating of treatment effect by patients. Mean (standard deviation) score at 2, 4, and 6 weeks or at end of treatment (maximum 8 weeks). | Salt bath + UVB | 299/310 | 77.8 (21.3) | UVB only | 270/301 | 59.0 (27.0) | n.r. |
| Schiener 20072 | " | Salt bath + UVB | 299/310 | 77.8 (21.3) | Tap water + UVB | 285/301 | 65.3 (29.4) | n.r. |
| Schiener 20072 | " | Salt bath + UVB | 299/310 | 77.8 (21.3) | Psoralen bath + UVA | 305/321 | 82.9 (22.5) | n.r. |
| Schiener 20072 | Global rating of tolerability by patients. Mean (standard deviation) score at 2, 4, and 6 weeks or at end of treatment (maximum 8 weeks). | Salt bath + UVB | 299/310 | 85.1 (16.7) | UVB only | 270/301 | 75.8 (21.3) | n.r. |
| Schiener 20072 | " | Salt bath + UVB | 299/310 | 85.1 (16.7) | Tap water + UVB | 285/301 | 82.3 (19.6) | n.r. |
| Schiener 20072 | " | Salt bath + UVB | 299/310 | 85.1 (16.7) | Psoralen bath + UVA | 305/321 | 88.6 (16.1) | n.r. |
| Schiener 20077 | Short Form of the Questionnaire on Experience with Skin complaints (SF‐QES). Change scores did not differ significantly between groups (P = 0.47). Overall median improvement was ‐0.14 (25th to 75th percentile, ‐1.27 to 0.00; n = 1107 participants). Assessment at 2, 4, and 6 weeks or at end of treatment (maximum 8 weeks). | no data | no data | no data | no data | no data | no data | 0.47 |
| Schiener 20078 | Self‐administered PASI (S‐PASI). Number of participants with reduction of S‐PASI by 50% or more (%) at 2, 4, and 6 weeks or at end of treatment (maximum 8 weeks). | Salt bath + UVB | 286/310 | 217 (75.9) | UVB | 258/301 | 134 (51.9) | <0.001 |
| Schiener 20078 | " | Salt bath + UVB | 286/310 | 217 (75.9) | Tap water + UVB | 266/301 | 174 (65.4) | 0.009 |
| Schiener 20078 | " | Salt bath + UVB | 286/310 | 217 (75.9) | Psoralen bath + UVA | 292/321 | 237 (81.2) | 0.13 |
1: P values reported by study
2: Brockow 2007b and Schiener 2007. Global ratings on on disease severity, treatment effect, and tolerability using 100‐mm visual analog scales. Positive change scores indicated improvement, higher scores at the end of treatment indicated better effectivenes or tolerability.
3: 183 patients were randomised to Salt bath + UVB. Data from 144 people were analysed and the data from the following 39 patients were not analysed: Three people did not start treatment; one person was not available for second PASI; early withdrawal concerned 35 people; see figure 1 of the article by Klein 2011.
4: 184 patients were randomised to UVB only. Data from 106 patients were analysed and the data from the following 78 patients were not analysed: Five people did not start treatment; two people were not available for second PASI; early withdrawal concerned 71 patients; see figure 1 of the article by Klein 2011. This figure states that 137 patients participated in the follow‐up six months after treatment. However, the same figure also states that only 106 participants were treated through to the end of treatment at session 35 which equals eight weeks after start of treatment. We suppose that this might be a spelling error.
5: Psoriasis disability index or Sickness impact profile change from baseline as a proportion from baseline as reported by Klein 2011 and calculated by review authors using the following formula: ((session 35 ‐ baseline) / baseline). The data show a better improvement in the Salt bath + UVB group compared to the UVB group for all six analyses, though, it is not clear whether the differences are statistically significant.
6: Quality of life index change from baseline as a proportion from baseline as reported and calculated by Leaute‐Labreze 2001 using the following formula: ((day 21 ‐ day 0) / day 0). The data show a decrease of quality of life index for both treatment groups, however, the quality of life index was not defined by the study and it is not clear whether the changes actually mean impairment or improvement.
7: Schiener 2007: The Short Form of the Questionnaire on Experience with Skin complaints (SF‐QES) consists of 4 subscales scored from 0 to 4. One scale has an inverse effect on the underlying construct. Total score, defined as the sum of all subscales, can range from −4 to +12. Higher scores indicate a higher level of stigmatisation feelings.
8: Schiener 2007: The Self‐administered PASI (S‐PASI) was operationalized in the same way as the PASI (reduction of S‐PASI or involved body surface area by 50% or more). The S‐PASI proved to be a reliable, valid, and responsive outcome measure. The S‐PASI is scored and interpreted in the same way as the PASI.
A/R: number of analysed/randomised people; n.r.: not reported; not stat signif: not statistically significant; PUVA: psoralen and ultraviolet A light; UVB: artificial ultraviolet B light