The remaining 2 of 4 Harmonising Outcome Measures for Eczema (HOME) domains in the core outcome set for atopic eczema clinical trials – quality of life (QoL) and long-term control – were finalized at the HOME VII meeting held in early April 2019, according to a report published in the British Journal of Dermatology. The other 2 domains are clinician-reported signs, measured by the Eczema Area and Severity Index (EASI), and patient-reported symptoms, measured by the Patient-Oriented Eczema Measure (POEM).
The meeting of 75 delegates included 43 (57%) healthcare professionals, 14 (19%) patients, 6 (8%) methodologists, and 12 (16%) industry representatives. The outcome instruments under consideration were selected using the HOME methodological roadmap and internationally agreed guidance for selecting outcome instruments. Up-to-date systematic reviews of validation studies for relevant outcome measurement instruments informed decisions during the meeting, which involved presentations, whole and small group discussions, and anonymous electronic voting.
Consensus was defined as fewer than 30% of voters disagreeing on a statement. Delegates connected to the development of specific instruments were excluded from voting on those instruments to avoid conflicts of interest.
Delegates voted for the Infant’s Dermatitis Quality of Life Index (IDQoL) for the infant QoL instrument with 8 of 70 (11%) disagreeing, the Children’s Dermatology Life Quality Index (CDLQI) for child QoL instrument with 6 of 69 (9%) disagreeing, and Dermatology Life Quality Index (DLQI) for adult QoL instrument with 11 of 72 (15%) disagreeing.
For long-term control, delegates voted for the Atopic Dermatitis Control Test (ADCT) and Recap of Atopic Eczema (RECAP) instruments, with 15 of 54 (27.8%) and 16 of 54 (29.6%) disagreeing, respectively. Long-term control was clarified as an eczema control measured repeatedly over time, but delegates did not reach a consensus on the frequency of data collection and will address it at future HOME meetings.
Delegates also voted for NRS-11 past 24 h (4 of 48 [8%] disagreed) as the instrument to measure itch intensity, a symptom singled out at a past HOME meeting as an important but unaddressed component of the POEM.
In terms of data collection frequency for outcome instruments, all 72 delegates agreed that, at a minimum, data should be collected at baseline and at the time of the primary outcome assessment, which usually corresponds to the end of treatment in clinical trials. Delegates will discuss data collection frequency in more detail at future HOME meetings.
The report’s authors noted that the finalization of all 4 HOME domain instruments provides greater validity to atopic eczema clinical trials.
“Trial results will be more readily incorporated into meta-analyses in systematic reviews and clinical care will be informed by the best available evidence,” they wrote.
Thomas KS, Apfelbacher CA, Chalmers JR, et al. Recommended core outcome instruments for health-related quality of life, long-term control and itch intensity in atopic eczema trials: results of the HOME VII consensus meeting. Br J Dermatol. Published online November 11, 2020. doi:10.1111/bjd.19673