Risk of bias for analysis 1.2 Gait speed ‐ paired assessment < 12 months.
| Study | Bias | |||||||||||
| Randomisation process | Deviations from intended interventions | Missing outcome data | Measurement of the outcome | Selection of the reported results | Overall | |||||||
| Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | |
| Kazui 2015 | Low risk of bias | Yes random block design, concealed. Both groups were well matched for age and symptom profile.. | Some concerns | No true deviations. No patient assigned to one intervention received the other. There were a few patients (2 controls and 1 active intervention) who did not receive the intervention. Per protocol used but there were 41 vs 35 participants post surgery. Some unexplained. The participants who were not analysed suffered from complications/illness. Difficult to attribute to shunting itself. |
Some concerns | 444 were randomised. 42 analysed. 41 had initial (control) data for this outcome (93%). 35 had follow up data but 6 had explanations and only 1 did poorly potentially because of the shunt (stroke). No sensitivity analysis was performed to assess impact of missing data. Most of the cases of lost follow up were explained. | Low risk of bias | 10m reciprocal walking test was used also but the result is similar and TUG had larger samples as it is more accepted and was probably used by more of the 26 participating centres. | Low risk of bias | TUG was used mosre often but 10m reciprocal WT also used. Similar results were seen with both methods however. | Some concerns | Some concerns due to missing outcome data and per protocol analysis. |
| Toma 2016 | Low risk of bias | Randomised in blocks by statastician. | Low risk of bias | One patient withdrew post shunt insertion but data was not included in results. | Low risk of bias | 14 of 15 patients randomised (93%) of patients had follow up data. | Low risk of bias | Measurement appropriate. Assessors not aware of group allocation. | Low risk of bias | Appropriate results selected. | Low risk of bias | Low risk of bias for all domains |
| Luciano 2023 | Low risk of bias | No additional comments. | Low risk of bias | No patient received the wrong intervention. | Some concerns | 8 fof 9 randomised had initial "control" data for this outcome (89%). 7 of 9 (78%) had intervention "shunt data". No specific reason was given for the additional patient without cognitive data. The missingless overall is small and only 1 case is unaccounted for and could have been due to true value. | Low risk of bias | Measurement of outcome was appropriate. | Low risk of bias | Reported results appropriate. Outcome assessors not aware of group allocation. | Some concerns | Some concerns due to missing outcome data. |