Which outcomes have been measured in hand eczema trials? A systematic review

Rönsch, Henriette; Apfelbacher, Christian; Brans, Richard; Matterne, Uwe; Molin, Sonja; Ofenloch, Robert; Oosterhaven, Jart A F; Schuttelaar, Marie L A; Weißhaar, Elke; Yew, Yik Weng; Bauer, Andrea

doi:10.1111/cod.13212

Cited by 20 publications

(28 citation statements)

References 21 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…There were 44 outcomes reported, and the majority of outcomes were categorized as skin and subcutaneous tissue outcomes. This finding is similar to what was found in another systematic review that identified and grouped outcomes of dermatology-related RCTs (20). Of the 55 outcome measurement instruments used to measure these outcomes, only 3 of these instruments were reported in different articles.…”

Section: Heterogeneity Of Outcome Measurement Instrumentssupporting

confidence: 88%

Outcome Measurements Used in Randomized Controlled Trials of Teledermatology: A Systematic Mapping Review

Chow¹,

Soon²,

Smith³

et al. 2019

Acta Derm Venereol

View full text Add to dashboard Cite

Assessment of the effectiveness of teledermatology is challenging due to different outcome measurements utilized. This review mapped 55 different outcome measurements reported in clinical trials of teledermatology using the Core Outcome Measures in Effectiveness Trials taxonomy. Each trial used a mean of 3.7 measurements (range 2-7), and most measurements measured "skin and subcutaneous tissue outcomes". The most frequently used measurement was used in only 3 studies. Over 60% of the measurements did not cite evidence of validation. This review provides a list of measurements for use in designing future teledermatology trials, and provides the foundation to develop a core outcome set. Assessment of the effectiveness of teledermatology has been hampered by the variety of outcome meas ures used, limiting the possibility for metaanalysis. This systematic mapping review classified the outcome measurement instruments used in randomized con trolled trials of teledermatology conducted between 2008 and 2018 using the Core Outcome Measures in Effectiveness Trials taxonomy. Sixteen articles de scribing 12 studies were identified. Each trial used a mean of 3.7 outcome measurements (range 2-7), with a total of 55 different instruments employed. Most in struments mapped on the "skin and subcutaneous tis sue outcomes" domain. The most frequently used in strument (Dermatology Life Quality Index) was used in only 3 studies. Over 60% of the instruments used did not cite any evidence of validation. This mapping review provides a list of outcome measurement instru ments that can be used as a resource when designing teledermatology trials in the future and provides the foundation for the development of a core outcome set.

show abstract

Section: Heterogeneity Of Outcome Measurement Instrumentssupporting

confidence: 88%

Outcome Measurements Used in Randomized Controlled Trials of Teledermatology: A Systematic Mapping Review

Chow¹,

Soon²,

Smith³

et al. 2019

Acta Derm Venereol

View full text Add to dashboard Cite

show abstract

“…This should give researchers a better understanding of the meaning of HECSI scores in daily practice and stimulate its use in clinical trials. Furthermore, the study adds information on responsiveness as a measurement property of the HECSI, establishing a firmer base on which the HECSI may be adopted in a core outcome set for hand eczema studies in the future …”

Section: Discussionmentioning

confidence: 99%

Responsiveness and interpretability of the Hand Eczema Severity Index

Oosterhaven

Schuttelaar

2019

Br J Dermatol

Self Cite

View full text Add to dashboard Cite

Summary Background The Hand Eczema Severity Index (HECSI) is used to measure the severity of hand eczema. It is unclear what HECSI scores mean and what is the minimally important change (MIC). Furthermore, its responsiveness has not been studied. Objectives To study the responsiveness and interpretability of the HECSI. Methods This was a prospective study covering two time points: baseline and after 4–12 weeks. Responsiveness was assessed using a criterion approach, with at least one‐step improvement on the ‘Photographic guide for severity of hand eczema’ as the anchor for important improvement. Interpretability of single scores was determined by defining severity bands based on agreement with the anchor. For change scores, the smallest detectable change (SDC) was calculated in patients indicating no change and the MIC was obtained in patients indicating that they had changed using three methods: mean cutoff, receiver operating characteristic (ROC) curve and 95% limit. Results In total, 294 patients participated (160 male, mean age 44·9 years). HECSI scores improved or deteriorated in parallel with the anchor. The area under the ROC curve was 0·86 (95% confidence interval 0·81–0·91). The final severity band for single scores had a κ‐coefficient of agreement of 0·694: clear, 0; almost clear, 1–16; moderate, 17–37; severe, 38–116; very severe, ≥ 117. The SDC in 93 unchanged patients was 40·3 points. The obtained MIC values were all smaller than the SDC. Conclusions The HECSI has good responsiveness. This study gives meaning to HECSI scores, which can be applied to clinical decision making and the design of clinical trials. We recommend that an improvement of 41 points on the HECSI is regarded as the minimally measurable true change. What's already known about this topic? The Hand Eczema Severity Index (HECSI) is one of the most widely used measurement instruments to measure the severity of hand eczema. The HECSI has good reliability, but its responsiveness and interpretability have not been studied. What does this study add? This study shows good responsiveness of the HECSI. A severity grading for single scores is proposed. The smallest detectable change and minimally important change for improvement are determined. What are the clinical implications of this work? The obtained values help to interpret HECSI scores in daily practice and clinical studies, and may facilitate researchers in the calculation of sample sizes for clinical trials.

show abstract

“…This review has already been completed and its methods and results have been published. 12 Its objective was to identify outcomes that were measured in previous trials, to group them in domains and to identify their measurement instruments. We conducted a systematic review of controlled and randomizedcontrolled HE trials published between 2000 and 2017, including therapeutic as well as preventive interventions.…”

Section: Phase 1: Identification Of Candidate Core Domainsmentioning

confidence: 99%

“…Efficacy/effectiveness domains emerging from the patient interviews will be compared domains gathered in a previous systematic review of HE trials. 12 Interviews with HE experts. The objectives of this project are to identify gaps in the long list of candidate domains and to involve more experts from Australia, Africa, Asia and the Americas in the CDS and COS development.…”

Section: Phase 1: Identification Of Candidate Core Domainsmentioning

confidence: 99%

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

Rönsch

Apfelbacher

Brans

et al. 2020

Acad Dermatol Venereol

Self Cite

View full text Add to dashboard Cite

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.

show abstract

Which outcomes have been measured in hand eczema trials? A systematic review

Cited by 20 publications

References 21 publications

Outcome Measurements Used in Randomized Controlled Trials of Teledermatology: A Systematic Mapping Review

Outcome Measurements Used in Randomized Controlled Trials of Teledermatology: A Systematic Mapping Review

Responsiveness and interpretability of the Hand Eczema Severity Index

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

Contact Info

Product

Resources

About