Lupus & antiphospholipid syndrome
Domains for inclusion in a novel Treatment Response Measure for Systemic Lupus Erythematosus (Treatment Response Measure for SLE (TRM-SLE)): results of a modified Delphi study
Authors' conclusion
Considering patient and clinician perspectives, we reached consensus to include eight disease activity domains for future development into the novel TRM-SLE clinical trial outcome measure, aiming to improve trial interpretability and success.
Study context
- Population
- Expert lupus clinicians and patient representatives rating domains of active SLE for the TRM-SLE outcome measure for SLE randomised controlled trials (RCTs)completed ≥1 Delphi round
- Participants
- 87 vs 13
- Comparison
- Clinicians vs Patient representatives
- Cliniciansn = 87
- Patient representativesn = 13
- Outcome
- Consensus for domain inclusion: all four characteristics (importance, appropriateness, representation, measurability) rated ≥7 on a 1-9 scale by ≥70% of participants
Methodological detailstwo-stage, online survey rounds, structured discussion meetings, prespecified consensus threshold
- Two-stage
- Online survey rounds
- Structured discussion meetings
- Prespecified consensus threshold
Recommendations
As reported in the abstract
Potential domains rated
34
Domains meeting consensus on importance in both clinicians and patients (Stage 1)
14
Domains meeting consensus on importance among patients only (Stage 1)
11
Domains reaching consensus on all characteristics after Stage 2: alopecia, arthritis, haemolytic anaemia, nephritis, mucosal ulcers, rash, serositis and thrombocytopenia
8
Further findings
Taskforce members nominating domains
- Members nominating domains
- 36/59 (61%)
Original publication
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