Sheehan‐Dare 1989.
Methods | Within‐participant, randomised controlled trial. Hands were unit of randomisation and analysis This study was conducted at a single department of dermatology in the UK |
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Participants | 25 participants with chronic constitutional hand eczema; participants with irritant or allergic contact dermatitis were excluded
Dropouts: 4 Inclusion criteria of the trial
Exclusion criteria of the trial
Study population
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Interventions |
Intervention • Topical PUVA thrice weekly for 6 weeks in 21/24 hands • Radiotherapy 90 Rad 50 KV 3 times with 21‐day interval in 21/24 contralateral hands for 6 weeks Participants were followed up until 18 weeks after initial treatment Duration 18 weeks (6 weeks of active treatment, 12 weeks of follow‐up) |
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Outcomes |
Primary outcomes of the trial Not defined Other outcomes
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Notes | The primary outcome adverse events and the secondary outcomes reduction in severity, participant‐rated and investigator‐rated, were included but did not provide reproducible data. Means of outcome scores were not given as exact figures but in a graphical presentation 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 | Quote: "patients were randomly allocated topical PUVA to one hand and superficial radiotherapy to the other using a pre‐determined code" Comment: participants were randomly allocated using a predetermined code |
Allocation concealment (selection bias) | Unclear risk | No details about how allocation was concealed from participants and clinicians |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "the procedure was carried out in such a way that patients were unable to tell which hand had received active treatment" Quote: "the topical PUVA treated hand received sham radiotherapy during which the X‐ray machine appeared to function normally but the power supply to the tube was interrupted such that no X‐rays were received by the patient" Quote: "the superficial radiotherapy treated hand was treated with a sham PUVA procedure. This consisted of an application of the organic solvent base without psoralen 5 min prior to exposure to the light source" Comment: participant blinding. We consider this an adequate way to blind participants, although personnel probably were not blinded to perform the procedures |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "patients were assessed by 2 observers (R.S‐D and M.G) who were unaware of the treatment status of each hand until the codes were broken at the end of the study" Comment: observer blinding; independent observers are considered an adequate method for detection bias |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No intention‐to‐treat analysis but per protocol (21 of 25 = more than 80%) |
Selective reporting (reporting bias) | Low risk | No trial registration found. No discrepancies between the Materials and Results sections |
Other bias | Low risk | Baseline comparisons: within‐participant design not applicable Diagnostic certainty: yes The study was completed |