Summary of findings 4. Endobronchial valves versus control.
| Endobronchial valves + optimal medical care versus optimal medical care for the treatment of chronic obstructive pulmonary disease | ||||||
| Patient or population: Participants suffering from chronic obstructive pulmonary disease Setting: Hospital Intervention: Endobronchial valves + optimal medical care Comparison: Optimal medical care | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with optimal medical care | Risk with endobronchial valves | |||||
| % change from baseline in FEV1 | The mean % change in FEV1 for optimal medical care ranged between ‐3.5% and 3.9% | The standardized mean difference in FEV1 in the intervention group was 0.48 (95% CI, 0.32 to 0.64) | ‐ | 703 (5 RCTs) | ⊕⊕⊝⊝ LOW1 | |
| Mortality at end of follow‐up | 30 per 1,000 | 35 per 1,000 | OR 1.07 (0.47 to 2.43) | 703 (5 RCTs) | ⊕⊕⊕⊝ MODERATE2 | |
| Units of SGRQ change from baseline | The mean units of SGRQ change for optimal medical care ranged between ‐3.7 units and 1 unit | The mean SGRQ change in the intervention group was 7.29 units fewer (95% CI, ‐11.12 to ‐3.45 units) | ‐ | 695 (5 RCTs) | ⊕⊕⊝⊝ LOW3 | |
| Change from baseline in lung function parameters other than FEV1 | The mean L change in RV for optimal medical care ranged between ‐0.13 L and 0.05 L | The mean RV change in the intervention group was 0.58 L fewer (95% CI, ‐0.77 to ‐0.39) | ‐ | 200 (3 RCTs) | ⊕⊕⊕⊝ MODERATE4 | |
| The mean L change in TLC for optimal medical care ranged between ‐0.12 L and 0.002 L | The mean TLC change in the intervention group was 0.34 L fewer (95% CI, ‐0.46 to ‐0.23) | ‐ | 107 (2 RCTs) | ⊕⊕⊕⊝ MODERATE5 | ||
| The mean change in RV/TLC for optimal medical care ranged between ‐0.64 and ‐0.4 | The mean change in RV/TLC in the intervention group was 5.76 fewer (95% CI ‐10.45 to ‐1.06) | ‐ | 118 (2 RCTs) | ⊕⊕⊝⊝ LOW6 | ||
| Meters change from baseline in 6MWD | The mean 6MWD change from baseline ranged between ‐17.3 and 10 meters | The mean 6MWD change from baseline in the intervention group was 38.12 meters more (8.68 more to 67.56 more) | ‐ | 379 (4 RCTs) | ⊕⊕⊝⊝ LOW7 | |
| Adverse events at end of follow‐up | 97 per 1,000 | 387 per 1,000 (189 to 631) | OR 5.85 (2.16 to 15.84) | 482 (3 studies) | ⊕⊕⊕⊕ HIGH | Pneumonia distal to the valves was the most common adverse event. Pneumothorax and COPD exacerbations were reported as well. Overall, pneumothorax was associated with higher clinical response. Valve removal or replacement or both were relatively common. |
| Cost‐ effectiveness | The mean modelled costs for control were EUR 15,432 at 10 years (mean QALY = 4.02) |
The mean modelled costs for control were EUR 25,857 at 10 years (mean QALY = 4.43) |
⊕⊕⊕⊝ MODERATE8 | |||
| *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; SGRQ: St George's Respiratory Questionnaire; FEV1: forced expired volume in one second; RV: Residual Volume; TLC: Total lung capacity; L: Liter; RCT: randomized controlled trial; 6MWD: Six‐Minute Walking Distance; SMD: Standardized Mean Difference; MD: Mean Difference | ||||||
| GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: 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 quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
1 Downgraded 2 levels due to inconsistency in results and imprecision: high heterogeneity in results and imprecision due to differences in participant‐selection criteria
2 Downgraded 1 level for imprecision: the upper end of CI indicated 2.4 times the odds of death.
3 Downgraded 2 levels due to inconsistency in results and risk of performance and detection bias: high heterogeneity in results and four studies were not blinded (SGRQ is dependent on participants' subjective answering).
4 Downgraded 1 level due to imprecision: low participant numbers
5 Downgraded 1 level due to imprecision: low participant numbers
6 Downgraded 2 levels due to inconsistency in results and imprecision: high heterogeneity in results and low participant numbers
7 Downgraded due to risk of performance bias and inconsistency in results: the 6MWD was effort‐dependent and could be influenced in non‐blinded studies and there was high heterogeneity in results
8 Downgraded 1 level due to imprecision: low participant numbers