King 1984.
Methods | Within‐participant, randomised controlled study This study was conducted at a single centre in a secondary care setting in the UK |
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Participants | 20 participants with chronic palmar eczema Evaluable: 15 (8 hyperkeratotic, 7 pompholyx). Dropouts: 5 Inclusion criteria of the trial
Exclusion criteria of the trial
Study population
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Interventions |
Intervention • Superficial ionising radiation fractionated 100 rad at 45 kV once weekly for 3 weeks; total dose 300 rad in 15/20 hands Control intervention • Placebo radiation once weekly for 3 weeks in 15/20 contralateral hands In both groups, the topical medication was continued unchanged Duration 3 weeks' active treatment with follow‐up until 6 months |
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Outcomes |
Primary outcomes of the trial Not defined Other outcomes
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Notes | Outcome 2 (photographs) was not used in the presentation of results 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: "the radiographer randomly selected one palm..." Comment: no further details are given |
Allocation concealment (selection bias) | Low risk | Quote: "neither patient nor doctor was aware which hand had received treatment, but a record was kept by a radiographer in a sealed envelope" Comment: the study used sealed envelopes. This is a clear description of an adequate allocation concealment procedure |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "neither patient nor doctor was aware which hand had received treatment, but a record was kept by a radiographer in a sealed envelope" Comment: double‐blinded. One hand received actual radiotherapy; the other received "simulated radiotherapy" in the same regimen. This was considered as an adequate way to blind participants. The radiographer (staff) was aware of the treatment arm, but we consider this the best possible way to blind participants |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "neither patient nor doctor was aware which hand had received treatment, but a record was kept by a radiographer in a sealed envelope" Comment: double‐blind design. At the end of the study, the records of the radiographer were studied. Observers had no direct access to the randomisation code due to the sealed envelope and were not involved in administration of treatment. This is considered an adequate method to blind outcome assessors |
Incomplete outcome data (attrition bias) All outcomes | High risk | No intention‐to‐treat analysis but per protocol (15 of 20 = less than 80%) |
Selective reporting (reporting bias) | Low risk | No trial registration found. We did not find discrepancies between Methods and Results sections |
Other bias | Low risk | Baseline comparisons: as within‐participant study not applicable Diagnostic certainty: yes The study was completed |