Three validated tools stand out as most useful to busy clinicians who assess and document clinical signs of atopic dermatitis (AD), a new consensus statement reports in JAMA Dermatology.
“After a consensus process informed by systematic reviews, the Eczema Area and Severity Index [EASI], the Validated Investigator Global Assessment for Atopic Dermatitis, and the Investigator’s Global Assessment multiplied by or measured concurrently with a body surface area assessment were recommended to measure clinical signs of AD in clinical practice,” Eric Simpson, MD, MCR, and colleagues in the Harmonizing Outcome Measures for Eczema Clinical Practice (HOME CP) initiative wrote.
“It is recommended that clinicians incorporate at least one of these feasible, validated instruments into their care of patients with AD in clinical practice and in their electronic health documentation to enhance clinical care and support empirical evidence generation, valuebased health care, and quality of care assessments,” they added.
To arrive at a consensus, the researchers used a mixed-methods design, including systematic reviews and a qualitative consensus approach built on prior efforts.
Researchers searched the standard medical databases for all validation articles of clinicianreported outcome measures for AD signs published between November 2012 and April 2022. Eligible articles described the development of a disease severity instrument or investigated one or more measurement properties: content validity, construct validity, responsiveness, reliability, measurement error, or interoperability.
The review included studies of clinical signs, severity assessed by single or multiple items, adult and pediatric patients, and outcome measures reported by clinicians or by clinicians and patients. The 22 articles that met their eligibility criteria described 16 instruments that evaluated clinical signs of AD and identified 12 instrument subvariants.
At a day-long, in-person consensus exercise in Montreal, Canada, in 2022, 34 patient and patient advocate research partners, health care professionals, methodologists, researchers, and industry representatives from 13 countries ranked instruments in the papers as “recommended,” “promising,” or “insufficient.”
The authors acknowledged limitations of their process, including a lack of peer review and a dearth of attendees and reviewers to extract data from the studies, assess their risk for bias, and verify results.
Dr. Simpson spoke with Physician’s Weekly (PW) about HOME-CP’s recommendations and how implementing them can improve AD documentation and patient care.
PW: For primary care physicians, dermatologists, and other clinicians, why is the consensus statement important now?
Dr. Simpson: With so much discussion about formally tracking patient outcomes, knowing exactly what to follow and document in the medical record is difficult. HOME-CP is an international voluntary outcomes group that seeks to standardize outcomes for clinical research in atopic eczema and clinical practice.
This paper describes the consensus on the best validated and feasible instruments for busy clinicians to document in the chart. More than 20 instruments measure eczema, and most have inadequate validation.
At the minimum, we recommend a global and body surface area assessment that can be done in less than 1 minute. This provides adequate and reliable data to support baseline severity documentation and help track treatment responses.
Did the results of your process surprise you?
We were surprised that a more complex measure the EASI was included. Although this instrument is not likely to be used in practices in the United States, it is performed routinely in clinical care at some European dermatology centers.
How might the consensus statement affect patient care?
Given the many disease severity measures, providing a list of validated and feasible instruments for clinical practice is helpful. These findings should improve documentation and potentially aid in therapeutic monitoring. They may even enable more consistent real world evidence generation.
What further related research might you and your colleagues pursue?
We are now looking at implementation issues. For example, are these recommended instruments being used in clinics? How can we spread the word? Our future work will involve helping practitioners use these instruments in clinics, evaluating instrument uptake in primary care and other practice settings, developing instrument use guides, and integrating electronic medical records
