Summary of findings for the main comparison. Leg Club compared with nurse home visits.
| Leg Club compared to nurse home visits | ||||||
| Patient or population: people with venous leg ulcers Settings: community Intervention: Leg Club Comparison: nurse home visits | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Leg Club | ||||||
| Number of people healed Follow‐up: 6 months | 294 per 1000 | 456 per 1000 (238 to 862) | RR 1.55 (0.81 to 2.93) | 67 (1 study) | ⊕⊕⊝⊝ low1,2 | |
| Recurrence of ulcers ‐ not reported | See comment | See comment | Not estimable | ‐ | See comment | Recurrence was probably measured but not reported |
| Time to healing ‐ not reported | See comment | See comment | Not estimable | ‐ | See comment | Time to healing was probably measured but was not reported |
| Adverse events ‐ not reported | See comment | See comment | Not estimable | ‐ | See comment | Not measured. |
| Quality of life Spitzer's quality of life index. Scale from 0‐10. Follow‐up: 6 months | The mean quality of life score in the control group was 8.11 | The mean quality of life score in the intervention groups was 0.85 higher (0.13 lower to 1.83 higher) | 52 (1 study) | ⊕⊕⊝⊝ low1,2 | ||
| Adherence to compression ‐ not reported | See comment | See comment | Not estimable | ‐ | ||
| Pain Medical Outcomes Study Pain Measures. Scale from: 0 to 100. Follow‐up: 6 months | The mean pain score in the control group was 34.29 | The mean pain in the intervention groups was 12.75 lower (24.79 to 0.71 lower) | 60 (1 study) | ⊕⊕⊝⊝ low1,2 | A 15 point difference is usually regarded as the minimum difference that is clinically important | |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High quality: further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: we are very uncertain about the estimate. | ||||||
1 Trialists failed to conceal allocation and may have performed an unplanned interim data analysis 2 Low number of participants therefore wide confidence intervals