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. 2020 Mar 19;2020(3):CD012517. doi: 10.1002/14651858.CD012517.pub2

Silva 1997.

Methods RCT.
Cross‐over design.
Location: single tertiary centre in Brazil.
Duration: 6 months per treatment arm, but washout period was not stated in paper.
Participants 26 participants randomised.
Age, median (range): 45.3 months (3.6 months to 15 years).
Gender split: 8 males, 18 females.
Diagnosis: CAH due to 21OH deficiency.
Interventions Group 1: HC 15 mg/m² 1x daily and FC 0.1 mg/day for 6 months.
Group 2: HC 25 mg/m² 1x daily and FC 0.1 mg/day for 6 months.
Outcomes 17 OHP, androstenedione, testosterone, GH, IGF‐1, growth pattern (height and weight).
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Treatment randomly assigned, but paper does not state how sequence was generated.
Allocation concealment (selection bias) Unclear risk No mention of allocation of concealment.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Each child was examined by the same physician who was blinded to the HC dosing schedule.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Each child was examined by the same physician who was blinded to the HC dosing schedule.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Attrition rate was not reported.
Selective reporting (reporting bias) High risk We did not have any access to the original trial protocols to definitely confirm whether this occurred and we attempted to contact the investigators but have not received a response.
Other bias Unclear risk We did not have any access to the original trial protocols to definitely confirm this but there was no washout period described in the paper for this cross‐over trial.