Lavi 2006.
Methods |
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Participants | 1. 63 patients enrolled (consecutive patients older than 18 years scheduled for a diagnostic or therapeutic lumbar puncture as a part of their routine clinical management)
2. 5 patients randomized were excluded due to:
3. 0 patients lost to follow‐up 4. Main characteristics of patients:
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Interventions |
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Outcomes | Outcomes were not classified as primary or secondary A. Incidence of PDPH B. Adverse events: not reported C. Severity PDPH D. Any headache subsequent to a lumbar puncture: not reported |
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Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information to score this item as low or high risk of bias. Quote: "Patients were randomly assigned to undergo LP with a standard (...).Patients were randomized only once. Therefore, those who required repeated LPs had them done with the same needle type." (page 1492) |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to score this item as low or high risk of bias |
Blinding of participants (performance bias) | Low risk | Quote: "The study was blinded to the patient. However, because the different needles have different structures, the physician knew which needle was used and could not be blinded to the needle." (page 1492) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Follow‐up was performed by a physician, blinded to the randomization, on days 2 (...)". (page 1492) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No patients were lost to follow‐up |
Selective reporting (reporting bias) | High risk | Adverse events, additional to PDPH, were not reported |
Other bias | Low risk | No other biases were identified |