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Table 2 Summary of blinding status

From: A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial

  Blinding status Comments
Participants Not blinded Not possible to blind participants, efforts will be made to minimise expectation bias
Research nurses and PI Blinded Participants will be reminded in their clinic appointment letters not to wear the clothing when they attend the clinic, or to mention the clothing in any way when talking to the research nurses
Trial staff at Nottingham CTU Not blinded Will be the main point of contact for participants wishing to contact the research team, will package and post the clothing to the participants according to the randomisation schedule, and will provide general advice
Statistician Blinded Statistician will finalise the analysis plan prior to revealing the treatment codes
  1. CTU Clinical Trials Unit, PI Principal Investigator