Child 2004.
Study characteristics | ||
Methods | This was a randomised, open‐label, cross‐over trial, which lasted 12 months. | |
Participants | The study recruited 16 participants (10 were in the PUVA‐first group; 6 were in the ECP‐first group) with plaque‐stage (1B ⁄ T2, Bunn Lamberg 1B) MF and a peripheral blood T‐cell clone (detected by polymerase chain reaction (PCR)‐single‐strand conformational polymorphism (SSCP) methodology), but with no evidence of lymph node involvement. Demographics of the included participants
Exclusion criteria of the trial
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Interventions |
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Outcomes |
Outcomes of the trial
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Notes | No information for funding and conflict of interests given. This study was conducted at Skin Tumour Clinic, St John's Institute of Dermatology, United Kingdom. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "envelopes, numbered from 1 to 20, randomly allocating patients to Group 1 or Group 2, were generated by the statistician." Comment: we judged this to be of low risk. |
Allocation concealment (selection bias) | Unclear risk | It was unclear whether the used envelopes were sealed and opaque. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | This was not possible because of different types of interventions, so we judged this domain as unclear risk. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | There was insufficient information to permit judgement. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 8/16 participants (50%) were lost to follow‐up: 3/10 participants in the PUVA‐first group and 5/6 participants in the ECP‐first group. |
Selective reporting (reporting bias) | Unclear risk | This was unknown. We contacted the corresponding author for additional outcome data, but we received no reply within 4 weeks. |
Other bias | High risk | It was unclear if concomitant medication was permitted. |