Kircik 2013.
Methods |
Study design: randomised controlled trial Study grouping: parallel group |
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Participants |
Baseline characteristics Overall
Inclusion criteria: (1) diagnostic: no information given on how atopic dermatitis was defined; (2) severity of condition: "subjects with uncomplicated atopic dermatitis"; (3) duration of condition: no information given; (4) site evaluated (e.g. face/back); no information given Exclusion criteria: not reported Group differences: information from interim report: "the treatment groups were balanced with respect to all demographic and baseline characteristics" |
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Interventions |
Intervention characteristics Levocetirizine
Placebo
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Outcomes |
Primary outcome 1: mean change in patient‐assessed symptoms: pruritus
Primary outcome 2: adverse events
Secondary outcome 2: mean change in quality of life, as measured by a standardised or validated quality of life measure (e.g. Dermatology Life Quality Index ‐ DLQI (Finlay 1994))
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Identification |
Sponsorship source: UCB Pharmaceuticals Country: USA Setting: secondary Comments: single‐centre Author's name: Leon Kircik Institution: Mount Sinai Health System Address: 1169 Eastern Pkwy # 2310, Louisville, KY 40217, United States |
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Notes | ‐ | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Information about the sequence generation process insufficient to permit judgement of low risk or high risk |
Allocation concealment (selection bias) | Unclear risk | Information insufficient to permit judgement of low risk or high risk |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Information insufficient to permit judgement of low risk or high risk Comment: it is not clear whether medication was identical in appearance to placebo |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information given as to how assessor was blinded (i.e. information insufficient to permit judgement of low risk or high risk) |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient reporting of attrition/exclusions to permit judgement of low risk or high risk. No information given about attrition given. Although study authors report no missing outcome data, whether all randomised participants contributed to data collection remains unclear |
Selective reporting (reporting bias) | High risk | Comment: reporting of data was rudimentary in the report and did not allow us to run necessary analyses. Contacting the study author failed as the study author did not respond |
Other bias | Unclear risk | Further risk of bias is possible, but information is insufficient to judge whether additional bias exists (e.g. no conflict of interest statement provided, but study was funded by UCB Pharmaceuticals) |