Pickard 2015.
Methods |
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Participants |
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Interventions | Treatment group 1/tamsulosin group
Treatment group 2/nifedipine group
Control group
Standard pain medication ‐ not described in detail. |
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Outcomes | Primary outcome measurements
Secondary outcome measurements
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Funding sources | UK National Institute for Health Research Health Technology Assessment Programme. | |
Declarations of interest | Trial author JN is a member of the HTA commissioning board and the NIHR HTA and Efficacy and Mechanism Evaluation editorial board. All other trial authors declare no competing interests. | |
Notes | Sample size calculation. Follow‐up at 4 and 12 weeks with questionnaires, case report forms during clinical visits, or telephone contact. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "... by a remote randomisation system." Comment: This method of random sequence generation was considered to have low risk of bias. |
Allocation concealment (selection bias) | Low risk | Quote: "... supplied by an independent Source." 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: "Participants, clinicians, and trial personnel remained unaware of the allocated group." Comment: Double‐blinding was performed; therefore risk of performance bias was considered to be low. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | No quotes available. Comment: Personnel responsible for outcome assessments were blinded; therefore risk of detection bias was considered to be low. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No quotes available. Comment: Small number of participants lost to follow‐up equally balanced between treatment 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 | Unclear risk | No quotes available. Comment: Time to stone passage was evaluated in only a small portion of the study group (potential selection bias); therefore risk of other bias was considered to be unclear. |