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. 2020 Jun 16;2020(6):CD012726. doi: 10.1002/14651858.CD012726.pub2

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 evidenceHigh 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