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

Kim, Thomas; Apfelbacher, Christian; Chalmers, Joanne R; Simpson, Eric L.; Spuls, P.I.; Gerbens, L.A.A.; Williams, HC; Schmitt, Jochen; Gabes, Michaela; Howells, Laura; Stuart, Beth; Grinich, Erin E.; Pawlitschek, Traci; Burton, T.; Howie, L.; Gadkari, Abhijit; Eckert, Laurent; Ebata, T.; Boers, Maarten; Saeki, Hidehisa; Nakahara, Takeshi; Katoh, Norito

doi:10.1111/bjd.19673

Cited by 27 publications

(39 citation statements)

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“…These dimensions serve as the basis for objective and subjective assessment instruments from which the end points used in clinical trials are derived. The Harmonising Outcome Measures for Eczema (HOME) initiative has established a core outcome set of tools and end points to be used in clinical trials [258][259][260][261] and are discussed in detail elsewhere 37 . For regulatory purposes, the end points based on clinical signs are typically considered as primary efficacy end points while PROs are secondary end points.…”

Section: Disease Dimensionsmentioning

confidence: 99%

Atopic dermatitis: an expanding therapeutic pipeline for a complex disease

Bieber

2021

Nat Rev Drug Discov

364

294

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Section: Disease Dimensionsmentioning

confidence: 99%

Atopic dermatitis: an expanding therapeutic pipeline for a complex disease

Bieber

2021

Nat Rev Drug Discov

364

294

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“…In April 2019, a preliminary version of these results, based on scoping searches, was presented at HOME VII and used to inform initial decisions about a recommended PROM for the long‐term control domain 6 . Some results were amended following further independent COSMIN assessments and changes to reporting of some studies following peer review (See Appendix for summary of changes).…”

Section: Discussionmentioning

confidence: 99%

“…Whilst further work is required to assess aspects of validity for the recommended instruments, HOME has now recommended a full Core Outcome Set, including two of the instruments assessed in this review 6 . The aim is for these to now be adopted in all clinical trials in eczema which measure eczema control.…”

Section: Discussionmentioning

confidence: 99%

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Measurement properties of patient‐reported outcome measures for eczema control: a systematic review

Stuart

Howells

Pattinson

et al. 2021

Acad Dermatol Venereol

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Atopic eczema (herein referred to as 'eczema') is a skin disease characterized by remitting and relapsing symptoms. The Harmonising Outcome Measures for Eczema (HOME) initiative was developed to establish a core outcome set (COS) for eczema to be measured for all future eczema trials. The core outcome set for atopic eczema clinical trials includes the domain for patient-reported eczema control, but a review of the validation of available eczema control instruments was lacking. We aimed to review the literature and systematically assess the measurement properties of validated patientreported outcome instruments that capture eczema control. PubMed and Ovid EMBASE were searched up to 24 January 2020 for any study that reported on PROM instrument development or validation. The COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) criteria were used to assess the quality of eligible studies.We screened 12 036 titles and abstracts and 58 full texts. A total of 12 papers were included, reporting on seven PROMS. These were assessed with respect to development, reliability, construct validity and responsiveness. Two instruments, Recap of Atopic Eczema (RECAP) and the Atopic Dermatitis Control Tool (ADCT), have been developed and validated to a sufficient standard to support their recommendation as patient-reported outcome instruments for measuring control of atopic eczema as part of the HOME Core Outcome Set.

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“…For clinical trials, the HOME initiative recommends POEM as the preferred instrument to measure patient-reported symptoms [74,75]. In addition, the initiative recently recognized ADCT and RECAP for long-term disease control measures [76]. In clinical practice, HOME recommended POEM and PO-SCORAD.…”

Section: Recap Of Ad (Recap)mentioning

confidence: 99%

The Unmet Needs in Atopic Dermatitis Control in Latin America: A Multidisciplinary Expert Perspective

Sánchez

Chérrez-Ojeda

Galván

et al. 2021

Dermatol Ther (Heidelb)

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Introduction: Adoption of control tools for atopic dermatitis (AD) in Latin America (LA) is currently very limited. Clinical assessment tools represent a practical method to measure the impact of treatment on disease activity and on the quality of life of patients. However, the use of these tools in the LA clinical practice setting is limited. Methods: A selected panel of Latin American experts in fields related to atopic dermatitis were provided with a series of relevant questions to address prior to the multi-day conference. Within this conference, each narrative was discussed and edited by the entire group, through numerous drafts and rounds of discussion, until a consensus was achieved. Results: The panel proposes specific and realistic recommendations for implementing control tools for AD care in LA. In creating these recommendations, the authors strove to address all barriers to the widespread use of these tools. Conclusion: This article includes a narrative analysis of barriers to AD control in LA and

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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

Cited by 27 publications

References 0 publications

Atopic dermatitis: an expanding therapeutic pipeline for a complex disease

Atopic dermatitis: an expanding therapeutic pipeline for a complex disease

Measurement properties of patient‐reported outcome measures for eczema control: a systematic review

The Unmet Needs in Atopic Dermatitis Control in Latin America: A Multidisciplinary Expert Perspective

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