| Methods |
Study design: parallel‐group randomised controlled trial. Setting: single centre/Egypt. Dates when study was conducted: August 2011 to July 2012. |
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| Participants |
Inclusion criteria: solitary radiopaque renal stones (10 to 20 mm). Exclusion criteria: multiple stones, moderate or severe hydronephrosis, active infection, coagulopathy, stone size < 10 mm or > 20 mm, bilateral renal stones, radiolucent stones, anatomical abnormality in the ureter or ureteropelvic junction, cardiac pacemaker and uremia. Diagnostic criteria: US, KUB and/or excretory urography. Total number of participants randomly assigned: 60. Group A (Slow SWL)
Group B (Fast SWL)
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| Interventions |
Group A (n = 30): SWL at 80 shock waves per minute. Group B (n = 30): SWL at 120 shock waves per minute. Co‐interventions: diclofenac paediatric suppository was prescribed as analgesia on discharge home. |
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| Outcomes |
Stone clearance
Secondary procedures
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| Notes |
Funding Sources: not stated Declaration of interests: not stated |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote from publication: 'Patients were recruited from the outpatient clinic and were prospectively randomised (envelope method) into 2 groups.' Randomisation sequence generation not described. |
| Allocation concealment (selection bias) | Unclear risk | Envelope method used. Unclear whether envelopes were sequentially numbered and opaque. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not described. |
| Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | Not described. |
| Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Objective outcomes are not likely to be influenced by lack of blinding. |
| Incomplete outcome data (attrition bias) Stone free rate | Low risk | All randomised participants were included in the analysis. |
| Incomplete outcome data (attrition bias) Serious adverse events or complications of treatment | Low risk | All randomised participants were included in the analysis. |
| Incomplete outcome data (attrition bias) Secondary procedures | Low risk | All randomised participants were included in the analysis. |
| Incomplete outcome data (attrition bias) Hospital stay | Unclear risk | No information given. |
| Incomplete outcome data (attrition bias) Pain | Unclear risk | No information given. |
| Selective reporting (reporting bias) | Unclear risk | Prespeicified outcomes were fully described, but no published protocol available. |
| Other bias | High risk | Stone component and stone size were different between the groups. |