HOME VII Meeting
The HOME VII meeting was held 8th - 10th April 2019 in Tokyo, Japan.
Agreement was reached on recommending instruments to measure quality of life, eczema control and itch intensity.
In summary the core outcome set is:
- Quality of Life (skin specific)
DLQI (adults), CDLQI (children), IDQoL (infants)
- The systematic reviews of measurement properties were updated with new validation studies, and the revised COSMIN checklist was applied. This checklist focuses on the key elements of validation and is somewhat less stringent in requirements for an instrument to be considered for recommendation.
- Most trials do not include a measure of skin-specific QoL so there is a need to recommend an instrument to encourage the uptake of this domain of the COS. In those trials that do, DLQI (adults), CDLQI (children), IDQoL (infants) are used in the vast majority.
- This group of instruments covers all ages and have good face-validity.
- New instruments are currently being developed and these should be considered in due course – all COS are “forever preliminary”.
- Eczema control (long-term control)
Atopic dermatitis control test (ADCT*) or Recap of atopic eczema (RECAP)*
- Two instruments were recommended for the COS: the ADCT and Recap.
- ADCT and Recap are very similar instruments, and are both newly developed. They both showed good measurement properties on initial testing but because there was no evidence for real-life use, it was not possible to select between them at this stage.
- HOME will also investigate how well a single-item control question performs and determine whether it can be recommended for the COS.
* The ADCT and RECAP were both developed in response to the call from HOME V in 2017 for instruments to be developed to measure the domain of long-term control. The instruments and their validation studies will be published in due course and made available via the HOME website.
- Clinician-reported signs
EASI (agreed previously)
- Patient-reported symptoms
POEM (agreed previously)
NRS-11 for itch intensity
- Numerical Rating Scale (NRS) 11 point for worst itch over the last 24 hours (Yosipovitch 2019) selected a systematic review of measurement properties of itch intensity scales.
- All validation data was in adults but we suggest using the instrument for anyone who can self-report. Further validation data on this instrument in younger people is required.
- Itch intensity measured in this way is unlikely to be appropriate for a proxy measure.
5. Timing of outcome measures
An additional recommendation was agreed that the core outcome set should be measured at baseline and the primary outcome timepoint, but there were no recommendations as yet for timing of any additional interim timepoints.
This is in addition to the previous recommendation to present mean [SD] at baseline and the primary outcome timepoint. These additional recommendations are essential to fulfilling the overall objective of being able to compare trial results and to be able to put them together in a systematic review.