Nebesio 2016.
Methods | RCT. Cross‐over design. Location: single tertiary centre in USA. Duration: 18 weeks, (6 weeks per treatment arm but no washout period). |
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Participants | Randomised 9 participants. Age, range: 4.8 to 11.6 years. Gender split: 4 males, 5 females. Diagnosis: CAH. |
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Interventions |
Group 1: HC 15 mg/m²/day in 3 doses. Group 2: PD 3 mg/m²/day in 2 doses. Group 3: DXA 0.3 mg/m²/day in a single dose. All treatment schedules lasted 6 weeks and then switched to another one |
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Outcomes | Mean ACTH, androstenedione, 17 OHP concentration, IGF‐1, GH, BMI, SNP. | |
Notes | Outcomes reported but not presented in the review: ACTH and SNP. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | 3 sequential 6‐week courses of treatment randomly assigned, but paper does not state how random sequence was generated. |
Allocation concealment (selection bias) | Unclear risk | No mention of allocation of concealment. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No mention of blinding of participants and personnel. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No mention of blinding of outcome assessments. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 4 participants withdrew due to difficulties with peripheral IV access but it did not state which groups these participants were in when they dropped out. |
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.Not all outcome measures listed in the 'methods' section of the paper were fully reported in the results. |
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. |