Summary of findings 3. Standard valve compared to self‐adjusting CSF flow‐regulating valve for hydrocephalus.
Standard valve compared to self‐adjusting CSF flow‐regulating valve for hydrocephalus | |||
Patient or population: participants with hydrocephalus Setting: inpatient procedure ‐ outpatient follow‐up (Canada, United States, France) Intervention: standard valve Comparison: self‐adjusting CSF flow‐regulating valve | |||
Outcomes | Impact | № of participants (studies) | Certainty of the evidence (GRADE) |
Treatment failure: morbidity associated with shunt placement that led to shunt revision Follow‐up: 2 years |
The incidence of treatment failure may be similar in those with the standard valve and the self‐adjusting CSF flow‐regulating valve (RR 1.08, 95% CI 0.79 to 1.47). Standard valve: 42% Self‐adjusting CSF flow‐regulating valve: 39% |
229 (1 RCT) | ⊕⊕⊝⊝ LOW 1 2 |
Adverse events: morbidity related to the shunt placement that has not led to shunt revision Follow‐up: 2 years |
The incidence of adverse events may be similar in those with the standard valve and those with the self‐adjusting CSF flow‐regulating valve. Range with standard valve: 0–1.9% Range with self‐adjusting CSF flow‐regulating valve: 0–7.2% |
229 (1 RCT) | ⊕⊕⊝⊝ LOW 1 2 |
Mortality In the early postoperative period (≤ 30 days) |
The included studies reported no events in this period (deaths). | 229 (1 RCT) | ⊕⊕⊝⊝ LOW 1 2 |
Mortality Beyond the early postoperative period (> 30 days) |
Nine patients died. No disaggregated data by each type of intervention were available. | 229 (1 RCT) | ⊕⊕⊝⊝ LOW 1 2 |
Quality of life | Not reported | ‐ | ‐ |
*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; CSF: cerebrospinal fluid; RCT: randomised controlled trial; RR: Risk 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 |
1 Downgraded one level due to high or unclear risk of bias in multiple domains in the included study
2 Downgraded one level due to few participants and events in the included study