Summary of findings for the main comparison. Electrical stimulation (plus standard care) versus sham/no ES (plus standard care) for treating pressure ulcers.
| Electrical stimulation (plus standard care) versus sham/no ES (plus standard care) for treating pressure ulcers | ||||||
| Patient or population: people with pressure ulcers Setting: inpatients and outpatients Intervention: electrical stimulation (plus standard care) Comparison: sham/no ES (plus standard care) | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | Number of ulcers (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with sham/no ES (plus standard care) | Risk with Electrical stimulation (plus standard care) | |||||
| Proportion of pressure ulcers healed (3 to 12 weeks) |
Study population | RR 1.99 (1.39 to 2.85) | 512 (11 RCTs) | ⊕⊕⊕⊝ Moderatea | ES may increase the proportion of pressure ulcers healed when compared with no ES. Absolute effect: 297 out of 1000 (from 207 more to 425 more). |
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| 149 per 1,000 | 297 per 1,000 (207 to 425) | |||||
| Time to complete healing (3 and 8 weeks) |
Study population | HR 1.06 (0.47 to 2.41) | 55 (2 RCTs) | ⊕⊝⊝⊝ Very lowb | It is uncertain if ES decreases time to complete healing when compared with no ES. | |
| 18 per 100 | 19 per 100 (9 to 38) | |||||
| Complications/ adverse events related to pressure ulcers (3 to 12 weeks) | Adverse events included redness of the skin, itchy skin, dizziness and delusions, deterioration of the pressure ulcer, limb amputation and occasionally death. | 602 (13 RCTs) |
⊕⊕⊝⊝ Lowc | The data were not sufficiently detailed or comparable to analyse quantitatively. | ||
| Quality of life (QoL) | No studies measured quality of life | |||||
| *The risk in the intervention group (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; OR: Odds ratio; | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: we have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
aDowngraded one level: once for serious risk of bias because a lot of the studies had either high or unclear risk of bias for performance bias and selective reporting. bDowngraded four levels: once for serious risk of bias because both studies had high risk of bias for two domains and one study had unclear risk of bias for another three domains; once for indirectness because the two studies were not reflective of all who are vulnerable to pressure ulcers; twice for imprecision. cDowngraded two levels: once for serious risk of bias because a lot of the studies had either high or unclear risk of bias for selection and attrition bias; once for imprecision.