Grattan 1991.
Methods | Within‐participant, randomised controlled trial The study was probably conducted in a secondary care setting at a single centre in the UK |
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Participants | 15 participants with vesicular hand eczema for at least 6 months
Dropouts: 3 Inclusion criteria of the trial
Exclusion criteria of the trial
Study population
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Interventions |
Intervention • Topical PUVA 3 times a week for 8 weeks on 12/15 hands Control intervention • UVA (with placebo psoralen paint) on 12/15 contralateral hands Moisturisers were allowed on both hands, and both hands received a small fraction of UVB from UVA lamps During an unclear follow‐up period, participants received a questionnaire Duration 8 weeks |
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Outcomes |
Primary outcomes of the trial Not defined Other outcomes
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Notes | Small number of participants. The secondary outcomes ‐ reduction in severity, investigator‐rated and participant‐rated, and time until relapse ‐ were included but did not provide reproducible data. Exact figures for main outcomes are not given; instead there are graphic presentations. Questionnaire assessment was performed after completion of the study, but duration of follow‐up in this questionnaire assessment remains unclear 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) | Unclear risk | Quote: "psoralen and placebo were randomised and coded by one independent investigator (GJS) and supplied in bottles labelled left and right" Comment: no further details |
Allocation concealment (selection bias) | Low risk | Quote: "psoralen and placebo were randomised and coded by one independent investigator (GJS) and supplied in bottles labelled left and right" Comment: randomisation and coding were accomplished by an independent investigator, and bottles were supplied labelled 'left' and 'right'; therefore the physician was unaware of allocation |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "psoralen and placebo were randomised and coded by one independent investigator (GJS) and supplied in bottles labelled left and right" Quote: "the placebo was...." Comment: double‐blind study with a similar looking placebo; it was not possible for the participant to distinguish these |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "the code was not broken until completion of the study" Comment: double‐blind design in which an independent investigator supplied the treatments. It was not possible for observers to know the treatment groups |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No intention‐to‐treat analysis but per protocol (12 of 15 = 80%) |
Selective reporting (reporting bias) | Unclear risk | No trial register found. No major differences between outcomes described in the Methods section and outcomes described in the Results section; however although the article text claims that separate scores for the T‐120 are described, we were unable to find a score for separate items |
Other bias | Low risk | Baseline comparisons: as within‐participant study not applicable Diagnostic certainty: yes The study was completed |