Cartwright 1987.
Methods | Within‐participant, randomised controlled trial This was a single‐centre study, conducted in the UK |
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Participants | 30 participants with bilateral symmetrical constitutional hand eczema, resistant to previous treatment
Dropouts: 12 Inclusion criteria of the trial
Exclusion criteria of the trial
Study population
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Interventions |
Intervention • Superficial X‐ray 300 Rad 10 kV 3 times with a 21‐day interval in 18/30 hands Control intervention • Placebo‐radiation in 18/30 contralateral hands 3 times with a 21‐day interval Participants were followed up for 18 weeks after initial treatment Participants continued application of tar paste or steroid ointments throughout the trial Duration 21 weeks (3 weeks active treatment, 18 weeks follow‐up) |
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Outcomes |
Primary outcomes of the trial Not defined. Other outcomes
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Notes | Secondary outcomes ‐ reduction in severity, investigator‐ and participant‐rated scoring ‐ were included but provided no reproducible data. Only graphic representation of outcome scores. Graphs in Figures 1 and 2 seem to have been exchanged. High dropout: 12 out of 30. Reasons given for the 12 dropouts: unwilling to attend, mostly because eczema improved 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: "according to a predetermined random code known by the radiographer..." Reference to a predetermined random code known only by the radiographer |
Allocation concealment (selection bias) | Unclear risk | No details about how allocation was concealed from participants and investigators, although the article states that only the radiographer knew the randomisation code |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "according to a predetermined random code known by the radiographer and unknown to patient and observer, one hand was irradiated with 300 rad (3 Gy) of Grenz rays (...) and the other hand treated in an exactly similar manner, except that sham therapy was given" Comment: participants were truly blinded and received placebo‐radiation. The radiographer was the only one aware of the randomisation code in that he had to programme the radiation; however in our opinion, this study could not have been done in another fashion; therefore we judged this trial to have low risk, although not all staff were blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "according to a predetermined random code known by the radiographer and unknown to patient and observer..." Comment: the observer was unaware of the allocation; however no further details are provided |
Incomplete outcome data (attrition bias) All outcomes | High risk | No intention‐to‐treat analysis but per protocol (18 of 30 = less than 80%) |
Selective reporting (reporting bias) | Unclear risk | No trial registration found. Outcomes mentioned in the Methods section are depicted in graphs and tables in the Results section; however participant‐ and observer‐rated graphs probably are switched because results in the participant section range from 0 to 3, and results for the observer range from 0 to 7 |
Other bias | Low risk | Baseline comparisons: within‐participant study was not applicable Diagnostic certainty: yes The study was completed |