Hermanns 2009.
Methods |
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Participants |
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Interventions | Treatment group
Control group
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Outcomes |
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Funding sources | None. | |
Declarations of interest | None. | |
Notes | Sample size calculated. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Enrolled patients underwent randomisation in a 1:1 fashion in blocks of 10 to receive either a daily single dose of tamsulosin (0.4 mg) or placebo. The sequence of randomisation was computer generated and was performed by the university hospital pharmacy using DatInf Randlist software v.1.0 (DatInf GmbH, Tübingen, Germany)." Comment: This method of random sequence generation was considered to be at low risk of bias. |
Allocation concealment (selection bias) | Low risk | Quote: "Randomisation data were kept strictly confidential in sealed envelopes, accessible only to the primary and senior investigator." Comment: This method of allocation concealment was considered to have low risk of bias. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The patient, the attending urologist were not aware of study arm assignments until the final assessment of outcome." Comment: double‐blind. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Personnel responsible for outcome assessments were blinded." Comment: double‐blind; therefore low risk of bias. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Patients were included in the final analysis on an intention‐to‐treat basis. Patients who experienced stone expulsion before first medication, who withdrew their consent, or who were lost to follow‐up were excluded from the analysis." Comment: missing outcome data and losses to follow‐up balanced in numbers across both groups; therefore risk of attrition bias was considered to be low. |
Selective reporting (reporting bias) | Low risk | No quotes available. Expected outcomes were reported according to objectives. Comment: Risk of reporting bias was therefore considered to be low. |
Other bias | Low risk | No quotes available. Study appears to be free of other sources of bias. Comment: No other sources of bias could be found; therefore risk of other bias was considered to be low. |