Core result sets developed by HOME Group to benefit atopic dermatitis research

Core outcome sets (COS), important outcomes that should be measured in clinical trials, are largely absent from atopic dermatitis (AD) research. This precludes combining evidence from systematic reviews of important therapeutic interventions for AD, resulting in a lack of unbiased evidence to guide clinical practice.

The international organization Harmonizing Outcome Measures for Eczema (HOME), established in 2010, aims to establish a comprehensive SOC for AD clinical trials. The HOME Group core set of domains for AD, established by an international panel of consumers and experts reaching a consensus of at least 30%, includes:

Clinical signs evaluated by a doctor using a score


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Clinical symptoms

Long term control flares

· Quality of life

The HOME Group’s roadmap for AD COS development includes several steps for each core area: identifying instruments, evaluating measurement properties and quality of validation studies for identified instruments, and determining which instruments are preferred. for the COS.

1. Symptoms

Identify instruments. Stand-alone measures such as the Visual Analogue Scale (VAS) or Numerical Rating Scale (NRS), and those that are part of a composite measure (measuring clinical signs as well as patient-reported symptoms), such as the SCORing Atopic Dermatitis (SCORAD) index, were commonly used to measure symptoms of AD.

Evaluate measurement properties and quality of validation studies of identified instruments. The following instruments had sufficient validation to be recommended for COS: Pediatric Itch Severity Scale (ISS), Patient-Oriented Eczema Measure (POEM), Patient-Oriented (PO-) SCORAD, Self-Administered Eczema Area Severity Index (SA- EASI) and adapted SA-EASI.

Determine which instruments are preferred for COS. POEM was voted the most appropriate instrument to measure AD symptoms and was included in the COS.

2. Panels

Identify instruments. EASI and SCOREAD were the most commonly used instruments to measure signs of AD in trials.

Evaluate measurement properties and quality of validation studies of identified instruments. EASI and SCOREAD have been the most studied instruments in validation studies, proving relevant to patients and providers in assessing disease severity.

Determine which instruments are preferred for COS. A consensus was reached to include EASI as a recommended instrument in the COS; however, SCOREAD remains a common instrument in AD trials alongside EASI.

3. Quality of life

Identify instruments. The most common instruments used to measure quality of life were the Dermatology Life Quality Index (DLQI) in adults, the Children’s Dermatology Life Quality Index (CDLQI) in children, the Infant’s Dermatitis Quality of Life Index (IDQOL) in infants and Dermatitis Family Impact (DFI) in caregivers.

Evaluate measurement properties and quality of validation studies of identified instruments. Two systematic reviews for adults, adolescents, children and infants measured 133 properties of 9 quality of life instruments.

Determine which instruments are preferred for COS. The HOME group voted to include IDQOL, CDLQI and DLQI in the COS.

4. Long-term control

Identify instruments. This was assessed using systematic reviews of long-term control measures used in RCTs and a review of definitions of AD flares. In addition, qualitative studies were included to allow definition of the concept of interest.

Evaluate measurement properties and quality of validation studies of identified instruments. The HOME group focused on global measures of AD control when deciding on candidate instruments for long-term control, as they agreed that repeated measurement of the previous 3 major domains was not sufficient to capture long-term control, and that it should instead be a separate domain assessed with global measures of AD control recorded repeatedly over time.

Determine which instruments are preferred for COS. The Summary of Atopic Eczema (RECAP) and Atopic Dermatitis Control Test (ADCT) were chosen for inclusion in the COS due to their good content validity, responsiveness, and promising results on all the psychometric properties currently being tested.

Once the instruments for each domain were chosen, the HOME group also established minimum thresholds for each instrument to ensure that they are used consistently throughout AD studies.

“We urge researchers, funders, regulators, health care commissioners, patients and caregivers, and all health professionals dealing with AD to demand the use of HOME COS so that all new evidence can be meaningfully combined for the benefit of the patient,” wrote the HOME group authors.

Disclosure: Some study authors have disclosed affiliations with biotechnology, pharmaceutical and/or device companies. Please see the original citation for a full list of author disclosures.

Reference

Williams HC, Schmitt J, Thomas KS, , et al., on behalf of HOME Initiative. The HOME core result set for atopic dermatitis clinical trials.J Allergy Clin Immunol. Published online March 26, 2022. doi:1016/j.jaci.2022.03.017

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