Summary of findings 2. 5‐ALA image‐guided surgery compared to standard surgery for high‐grade glioma.
5‐ALA image‐guided surgery compared to standard surgery for high‐grade glioma | ||||||
Patient or population: high‐grade glioma Settings: specialist centres Intervention: 5‐ALA image‐guided surgery (based on post‐operative MRI) Comparison: standard surgery | ||||||
Outcomes | Illustrative comparative risk* (95% CI) | Relative effect (95% CI) | No. of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
Control | Image‐guided surgery | |||||
Extent of resection: complete resection | 641 per 100 | 35 per 100 (27 to 45) | RR 0.55 (0.42 to 0.71) | 270 participants (1 study) |
⊕⊕⊝⊝2 low | Highly selected participants with potential bias in allocation and performance |
Adverse events | Inadequately and inconsistently reported in the trial | ⊕⊝⊝⊝3 verylow | Adverse events were reported in an inconsistent manner and not according to the manner prespecified in our protocol. Additionally, we were mainly interested in identifying serious adverse events, which were inadequately reported | |||
Overall survival | Not estimable due to reporting of HR and since just a single trial reported on this outcome we did not arbitrarily choose a snap shot in time in which to use as basis to calculate the assumed and corresponding risks as this may be misleading. | HR 0.82 (0.62 to 1.07) |
270 participants (1 study) |
⊕⊕⊝⊝2 low | The overall quality of this outcome was low in this trial and was downgraded for highly selected participants with potential bias in allocation and performance | |
Progression‐free survival | Not adequately reported in the trials | ⊕⊝⊝⊝3 verylow | Progression‐free survival or time to progression was not adequately reported in the trial | |||
Quality of life | Inadequately reported or not assessed at all in the included trials | ⊕⊝⊝⊝3 verylow | Quality of life was not reported in the trial | |||
*The basis for the assumed risk is only based on individual trials as only single trial reports were available. 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). 5‐ALA: 5‐aminolevulinic acid; CI: confidence interval; HR: hazard ratio; 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. |
1Expressed in terms of risk of incomplete resection (bad outcome). 2Highly selected participants with potential bias in allocation and performance as well as in other 'Risk of bias' domains, thus downgraded by two levels. 3Outcome was not reported (or inadequately reported for meaningful conclusions to be drawn), therefore giving lowest quality of evidence judgement.