Bayerl 1999.
Methods | Parallel‐group, randomised controlled trial The study was conducted in the secondary setting at 2 different dermatology departments in Germany |
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Participants | 48 participants with chronic hand eczema (21 irritant, 18 allergic, 9 atopic) > 3 months' duration, more than 30% of the hands involved. All had occupation‐related hand eczema: 41% were in a wet occupation
Dropouts: 12 Inclusion criteria of the trial
Exclusion criteria of the trial
Study population
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Interventions |
Intervention • UV‐B phototherapy 5 days/week for 8 weeks in 19/24 participants Control intervention • No UVB for 8 weeks in 17/24 participants Both groups were allowed to use non‐specific creams/emollients Duration 8 weeks |
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Outcomes |
Primary outcomes of the trial Not defined Other outcomes
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Notes | Study authors rightly state that this is a pilot study. Only graphic presentation of a few components of some outcome parameters. Not clear, but assumed, that 24 participants were randomised to each group. The secondary outcome ‐ reduction in severity, investigator‐rated ‐ was included but did not provide reproducible data Study authors were contacted on 7 March 2014 and responded 10 March 2014 Declarations of interest: not stated Funding: not stated Sample size rationale: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The article states only that the study is randomised, without details about the method of randomisation. Personal communication clarified that the same method was used as in Adams 2007: "cards with the characterisation "A" and "B" were enclosed in envelopes by a third person, mixed like a card play by a third person, then numbered consecutively by a third person and opened by the study doctor consecutively after informed consent to the study" This is an adequate method |
Allocation concealment (selection bias) | Low risk | No details about whether the allocation was concealed from participants and investigators in the article, but personal communication clarified that this was done appropriately by a third person, and that the study doctor and participants opened the consecutively numbered envelopes after informed consent was retrieved |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel were not blinded during the study |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Observers were not blinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | No intention‐to‐treat analysis but per protocol (36 of 48 = less than 80%) |
Selective reporting (reporting bias) | Low risk | No trial registration found; however outcomes described in Materials and Methods are depicted in the Results section and are adequate |
Other bias | Unclear risk | Baseline comparisons: no baseline comparisons regarding group differences (randomisation check) Diagnostic certainty: yes The study was completed |