Protocol for the development of a core domain set for hand eczema trials

Abstract

Background Clinical hand eczema trials measure a variety of outcome domains to determine the success of interventions. This considerably limits the comparability and overall confidence in the study results, and thereby the strength of recommendations for clinical practice. Objectives The Hand Eczema Core Outcome Set (HECOS) initiative aims to develop a core outcome set (COS) for the standardized evaluation of interventions in future hand eczema trials and reviews. This COS will define the minimum that should be measured and reported in controlled and randomized-controlled trials of therapeutic hand eczema interventions. The objective of this protocol is to specify the methods to develop a core domain set. Methods In Phase 1, a list of candidate domains will be derived from a systematic literature review concerning previously measured outcomes in hand eczema trials, from qualitative patient interviews and from expert interviews. In Phase 2, a consensus study about core domains will be conducted by an online 3-round Delphi survey and a face-to-face meeting, applying predefined consensus criteria. HECOS involves hand eczema and methods experts as well as patients and further stakeholders with an interest in the initiative. Outlook When a set of core domains has been defined, HECOS is going to identify appropriate outcome measurement instruments in a development process that will be detailed in another protocol. The COS will considerably enhance the methodological quality, comparability and usefulness of hand eczema trials for clinical decision-making and the development of new therapeutic options for hand eczema, and also reduce the effort of planning, conducting, and reporting individual hand eczema studies, reviews and meta-analyses.

Evaluation of the secondary and tertiary prevention strategies against occupational contact dermatitis in Germany: A systematic review

“…Second, heterogeneity among the interventions (especially the SIP interventions), outcomes, and measurement instruments hampered direct comparisons between the studies. Recently, a protocol was published to help standardize outcome measures for evaluating hand dermatitis 43 . Standardized methods for evaluating interventions that are designed to prevent occupational contact dermatitis would enhance the quality of future studies and make these studies easier to compare.…”

“…Recently, a protocol was published to help standardize outcome measures for evaluating hand dermatitis. 43 Standardized methods for evaluating interventions that are designed to prevent occupational contact dermatitis would enhance the quality of future studies and make these studies easier to compare.…”

Hand eczema among healthcare workers in Guangzhou City: a cross-sectional study

“…This suggests that along with hypersensitivity screening, alternative methods for hand hygiene are required to reduce occupational exposure. More well-designed clinical trials like quasi-experimental and randomized trial, either an individual randomized trial or a cluster randomized trial, reporting an agreed standardized set of outcomes (35), are in need to look at the long-term effect of multifaceted interventions for avoiding exposure and risks factors and providing with career guidance.…”

Which outcomes should be measured in hand eczema trials? Results from patient interviews and an expert survey

“…Outcome measurement instruments refer to 'how' domains should be measured, which will be considered in future steps of HECOS. 9 A 'Long List' of outcome domains is a compilation of all (sub-)domains that could potentially be part of a core domain set. In HECOS, outcomes identified by the systematic literature review, 8 patient interviews and an expert survey were combined to one 'Long List' of candidates for core domains in therapeutic HE trials.…”

“…whether 'hyper-' and 'hypopigmentation', or 'sleep disturbances' and 'tiredness', respectively, should be one or two items in the envisaged eDelphi). 9 First, an initial list was created based on the review of previously measured domains in clinical HE trials. 8 Second, patient interviews were coded according to this list.…”