Elderwy 2014

Methods	Study design: parallel‐group quasi‐randomised controlled trial. Setting: single centre/Egypt. Dates when study was conducted: September 2010 to September 2012.
Participants	Inclusion criteria: uncomplicated radiolucent stone, mean stone density < 500 HU on NCCT, total stone length < 25 mm and a normal upper urinary tract or grade 1 hydronephrosis. Exclusion criteria: not stated however 239 assessed for eligibility and 96 included. Diagnostic criteria: KUB, US, abdominopelvic NCCT, urinalysis and urine culture, complete blood count, serum uric acid, serum calcium and phosphorus, and a coagulation profile. Total number of participants randomly assigned: 96. Group A (SWL) Number of participants randomly assigned: 39. Age (median): 2.5. Gender (M/F): not reported. Group B (potassium sodium hydrogen citrate) Number of participants randomly assigned: 48. Age (median): 2.5. Gender (M/F): not reported.
Interventions	Group A (n = 39): SWL group. Lithotripter S under general anaesthesia. Single dose of intravenous first‐generation cephalosporin before induction. US monitoring used and a total count of 2000 per session at 12 to 14 kV power and a frequency of 60 to 70 per minute. Group B (n = 48): oral potassium sodium hydrogen citrate at a dose of 1 mEq/kg per day in 2‐3 divided doses after meals for 1‐3 months. Co‐interventions: 15 mg/kg dose of oral paracetamol every 8 hours for 3‐5 days and to maintain a high fluid intake.
Outcomes	Stone clearance How measured: stone‐free when US within 3 months showed no evidence of stones. Time points measured: every 3‐4 weeks, by Urinalysis and US, and every 3‐4 months thereafter. Time points reported: 1 month, 2 month and 3 month for medical therapy. Not reported for SWL. Subgroup: none. Complications How measured: US. Time points measured: as 'at end of study'. Time points reported: as 'at end of study'. Subgroup: none. Secondary procedures How measured: not reported. Time points measured: not reported. Time points reported: not reported. Subgroup: none.
Notes	Funding Sources: not stated. Declaration of interests: not stated.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Patients were quasi‐randomised into 2 treatment groups by month of presentation. Those who presented in odd months received oral dissolution therapy and those who presented in even months were treated with SWL.
Allocation concealment (selection bias)	Unclear risk	Not described.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not described.
Blinding of outcome assessment (detection bias) Subjective outcomes	Low risk	Quote from publication: "Radiologist were blinded to the procedures".
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	Unclear risk	3/51 (5.8%) and 6/45 (13.3%) participants in medical and SWL group were not included in the analysis, respectively. Adherence of participants may not be balanced across intervention groups.
Incomplete outcome data (attrition bias) Serious adverse events or complications of treatment	Unclear risk	3/51 (5.8%) and 6/45 (13.3%) participants in medical and SWL group were not included in the analysis, respectively. Adherence of participants may not be balanced across intervention groups.
Incomplete outcome data (attrition bias) Secondary procedures	Unclear risk	3/51 (5.8%) and 6/45 (13.3%) participants in medical and SWL group were not included in the analysis, respectively. Adherence of participants may not be balanced across intervention groups.
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	Prespecified outcomes were fully described, but no published protocol available.
Other bias	Low risk	Not detected.