Summary of findings 3. Voice‐enabling communication aid compared to usual care with an aid for adults requiring an artificial airway with or without mechanical ventilator support.
| Voice‐enabling communication aid compared to usual care with an aid for adults requiring an artificial airway with or without mechanical ventilator support | ||||||
| Patient or population: adults requiring an artificial airway with or without mechanical ventilator support Setting: – Intervention: voice‐enabling communication aid Comparison: usual care with an aid | ||||||
| Outcomes | № of participants (studies) | Anticipated absolute effects (95% CI) | Relative effect (95% CI) | Certainty of the evidence (GRADE) | Comments | |
| Risk with usual care using an aid | Risk with voice‐enabling communication aid | |||||
| Proportion able to communicate | 50 (2 RCTs) | — | — | RR 3.03 (0.18 to 50.08) | ⊕⊝⊝⊝ Very lowa,b,c | Downgraded 1 level for serious risk of bias, 1 level for imprecision, and 1 level for inconsistency. |
| Health‐related quality of life assessed with: QOL‐MV | 63 (2 RCTs) | — |
MD 2.27 higher
(95% CI 7.21 lower to 11.75 higher) The QOL‐MV is reported on a scale of 0–100 with lower scores indicating worse quality of life. Scores were assessed repeatedly over time from baseline and following treatment sessions. |
— | ⊕⊕⊝⊝ Lowa,b | Downgraded 1 level due to serious risk of bias and 1 level for imprecision. |
| Emotional and psychological distress | 80 (2 RCTs) |
1 study (30 participants) reported 7/8 domains of the VASES had mean between‐group differences that favoured the intervention group. VASES was measured at baseline, then daily on weekdays until return of voice. VASES is a 10‐item scale with items scored on a bipolar scale. 1 study (50 participants) reported intervention participants had lower mean scores (12.1 (SD 9.0)) (indicating more emotional distress) on the QOL‐MV emotional domain at treatment session end compared to control (13.5 (SD 6.6); and compared to their own baseline measurement (13.5 (SD 6.9)). Mean scores on the V‐RQOL emotional domain were higher (46.1 (SD 23.1) (indicating less emotional distress) compared to the control group (35.7 (SD 30.9). The QOL‐MV and V‐RQOL both comprise emotional and physical domains. Higher scores indicate less emotional distress. |
— | ⊕⊝⊝⊝ Very lowa,b,d | We downgraded 1 level due to serious risk of bias, 1 level for imprecision, and 1 level for inconsistency in results. | |
| ICU length of stay (days) and healthcare costs | 100 (3 RCTs) | — | ICU length of stay: MD 0.2 days longer (0.04 fewer to 0.44 longer) | — | ⊕⊕⊕⊝ Lowa,b | We downgraded 1 level due to serious risk of bias and 1 level for imprecision. No study measured healthcare costs. |
| Adverse events | 50 (2 RCTs) |
1 study of 30 participants reported 5 participants in both study arms experienced clinical events including oxygen desaturation, increased respiratory rate, increased upper respiratory tract secretions, excessive coughing, and hypertension. 1 study of 20 participants measured bleeding following percutaneous tracheostomy insertion with no participants in either study arm experiencing this adverse event outcome. |
— | ⊕⊕⊝⊝ Lowa,e | We downgraded 1 level due to serious risk of bias and 1 level due to imprecision. | |
| *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; ICU: intensive care unit; MD: mean difference; QOL‐MV: Quality of Life in Mechanically Ventilated Patients; RCT: randomised controlled trial; RR: risk ratio; SD: standard deviation; VASES: Visual Analogue Self‐Esteem Scale; V‐RQOL: Voice‐Related Quality of Life. | ||||||
| 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. | ||||||
aThe two included studies were at serious risk of performance and detection bias. bThe pooled estimate demonstrated wide confidence intervals and was based on a small number of participants. cI²statistic = 77%. dThe two included studies reporting conceptually different measures of emotional distress. One study reported results favouring the intervention whereas the second reported equivocal results. eThe results are based on two studies with a small number of participants.