Table 1.
Additional guidance for scoring the 10 PRECIS domains in the context of the BLISTER trial
PRECIS domain | Description in the context of BLISTER |
---|---|
Eligibility criteria |
Are most patients who would normally be treated included in the trial? How strict are the criteria? |
Follow-up intensity |
How similar to normal practice is the patient follow-up? |
Primary outcomes |
Would those considered to be a treatment success in the trial (for example, three or fewer blisters present at six weeks of follow-up) also be considered a treatment success in practice? |
Method of analysing the primary endpoints |
Are there many exclusions from the analysis? How inclusive is the definition of per-protocol? |
Doxycycline and prednisolone flexibility |
Can trial treatments be altered during follow-up or are patients expected to stay on the prescribed dose? Is this any different to normal practice? |
Practitioner expertise on doxycycline and prednisolone |
Are patients seen by specialists? Would they normally be seen by, for example, general practitioners? |
Participant compliance |
How closely is this measured? Are there interventions made to maintain or improve compliance? |
Practitioner adherence to the protocol | Is the study concerned whether investigators ‘customise’ the trial to suit their own setting? Are all investigators expected to treat patients in the same way? |