Stellbrink 2002.
Methods | Prospective RCT | |
Participants | There were 56 participants. Inclusion criteria
Exclusion criteria
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Interventions |
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Outcomes |
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Notes | This was an open label RCT conducted in Germany. Mean follow‐up duration ranged from 582 ‐ 601 days. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The trial authors did not report the method of sequence generation. |
Allocation concealment (selection bias) | Unclear risk | The trial authors did not report the method of allocation concealment. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | The trial was not blinded. However, the outcome measures are objective and unlikely to have been influenced by lack of blinding. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The trial was not blinded. However, the outcome measures are objective and unlikely to have been influenced by lack of blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The trial authors performed analysis was ITT and there were no losses to follow‐up. |
Selective reporting (reporting bias) | Low risk | There was no evidence of selective reporting. |
Other bias | Low risk | There was no evidence of other potential sources of bias. |