Responsiveness and interpretability of the Hand Eczema Severity Index (HECSI)

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

Validation of the Dutch Quality of Life in Hand Eczema Questionnaire (QOLHEQ)

Background: Measurement instruments should be validated for use in the population for which they are intended. The Quality of Life in Hand Eczema Questionnaire (QOLHEQ) has been developed to measure impairment of health-related quality of life in patients with hand eczema. Objectives: To assess validity, reproducibility, responsiveness and interpretability of the Dutch version of the QOLHEQ. Methods: This was a prospective validation study in adult patients with hand eczema. At three time points (T0, baseline; T1, after 1–3 days; T2, after 4–12 weeks), data from the QOLHEQ and multiple reference instruments were collected. Scale structure was assessed using item response theory analysis and structural equation modelling (SEM). Single-score validity and responsiveness were tested with hypotheses on correlations with reference instruments. Concerning reproducibility, intraclass correlation coefficients (ICCagreement) and standard error of agreement (SEMagreement) were checked. Regarding interpretability, bands for severity of quality-of-life impairment were proposed. Also, smallest detectable change (SDC) and minimally important change (MIC) were determined. Results: At T0, 300 individuals participated in the study (54% were male, mean age 45 years). Rescoring of the scale structure fitted the Rasch model and the SEM. The ICCagreement was 0·91 (95% confidence interval 0·85–0·94) and the SEMagreement was 5·2 points. Of the a priori formulated hypotheses, 80% (single-score validity) and 64% (change scores for responsiveness) were confirmed. The SDC was 14·4 points and the MIC was 11·5 points. Conclusions: The Dutch version of the QOLHEQ has a good structural validity and reproducibility and has a high single-score validity and moderate responsiveness. An improvement of ≥ 15 points should be regarded as a real, important change within the Dutch population. What's already known about this topic?. The Quality of Life in Hand Eczema Questionnaire (QOLHEQ) measures impairment of health-related quality of life (HRQoL) in patients with hand eczema. The QOLHEQ was validated in Germany and Japan, but the validity and interpretability of the Dutch version are unknown. What does this study add?. This study shows that the Dutch QOLHEQ is a valid instrument to measure HRQoL impairment in Dutch patients with hand eczema, demonstrating good reliability and moderate responsiveness. Methods of item response theory are applied to assess and refine the scoring structure. Severity gradings to interpret single and change scores, specifically in Dutch patients, are proposed. What are the clinical implications of this work?. The Dutch QOLHEQ can now be used to measure HRQoL impairment in Dutch patients with hand eczema

Verslag van een bezoek aan Curacao ter orientatie over de situatie op het gebied van levensmiddelenwetgeving, -controle en -productie, 3 - 12 november 1987

Om enig inzicht te krijgen in de kwaliteit van levensmiddelen, de wetgeving en de controle en een onderzoekprogramma op te stellen werd van 4 t/m 12 november 1987 een werkbezoek aan Curacao gebracht. Het programma bevatte de volgende onderdelen: kennismaking met de Fundashon pa Konsumido, bezoeken aan diverse levensmiddelen- en non-food produktiebedrijven, het Landslaboratorium, contacten met politici, kennismaking met controlediensten, bezoek aan de Universiteit van de Nederlandse Antillen, bezoek aan supermarkten en een persconferentie ter afsluiting

Validation of questionnaire algorithm based on repeated open application testing with the constituents of fragrance mix II:the EDEN Fragrance Study

Background: In a European study on contact allergy in the general population, it has been hypothesized that the combination of contact allergy to a fragrance together with a history indicating dermatitis at exposure and thereafter subsequent avoidance of scented products implied a diagnosis of allergic contact dermatitis. Objectives: The primary aim of this study was to validate this hypothesis/algorithm. The secondary aim was to investigate whether there was any association between the outcome of the recent repeated open application test (ROAT) and the patch test reactivity. Methods: One hundred nine subjects with and without contact allergy to fragrance mix II (FM II) were recruited. Volunteers from six European dermatology clinics participated in the study including a patch test and a ROAT. Results: Twenty-four positive ROAT reactions were noted in total including 20 of those 32 with contact allergy to FM II. None of the volunteers reacted to the vehicle (P < 0.001). More individuals with a positive algorithm had positive ROATs when compared with those with a negative algorithm. However, the difference was not statistically significant (P = 0.12). The lower the patch test concentration eliciting a positive test reaction, the more likely was a positive ROAT and the more likely that the positive ROAT appeared early during the investigative period. Conclusions: The algorithm used in this study was not validated but it was indicated in this ROAT setup. The stronger the patch test reactivity the more likely was a positive ROAT and the more likely it was that the positive ROAT appeared early during the application period

Patients' perspectives on quality of care for chronic hand eczema:a qualitative study

BACKGROUND: Hand eczema (HE) has a significant impact on quality of life and work related activities. Little is known about the patients' perspectives on quality of care for HE. OBJECTIVES: To evaluate the patient perspective of the HE care process in a tertiary referral center. METHODS: Qualitative, semi-structured focus groups were carried out and recorded, transcribed and analysed by an inductive-deductive thematic approach. RESULTS: Fifteen patients participated in four focus groups. Time and attention, together with being listened to and understood by the health care professional, were the most important aspects of care for HE mentioned by participants. Other important insights included: Diagnoses, causes and follow-up of HE were not always clear to the participant; more psychosocial support was needed; participants experienced frequent changes in doctors. Information provided by nurses was valuable, but more individualized advice was needed. CONCLUSIONS: In order to better meet the needs of patients, more explanation should be given about the causes of HE and final diagnosis. Besides focusing on the treatment, it is also important to focus on its impact on the patient and options for psychosocial and peer support should be discussed. Furthermore, the specialized nurse as part of integrated care was emphasized. This article is protected by copyright. All rights reserved

Validation of a questionnaire algorithm based on repeated open application testing with the constituents of fragrance mix I

Background In a European study on contact allergy in the general population, it was hypothesized that the combination of contact allergy to a fragrance together with a history indicating dermatitis at exposure, and thereafter subsequent avoidance of scented products, implied a diagnosis of allergic contact dermatitis. Objectives The primary aim of this study was to validate this hypothesis and algorithm. The secondary aim was to investigate whether there was any association between the outcome of the repeated open application test (ROAT) and the patch test reactivity. Methods In total, 109 patients with and without contact allergy to fragrance mix (FM) I were recruited. Volunteers from six European dermatology clinics participated in the study including a patch test and a ROAT. Results Positive ROAT reactions were noted in 26 of the 44 volunteers with contact allergy to FM I. None of the volunteers reacted to the vehicle (P <0 center dot 001). More individuals with a positive algorithm had positive ROATs than those with a negative algorithm. However, the difference was not statistically significant. The lower the patch test concentration eliciting a positive test reaction, the more likely a positive ROAT and the more likely that the positive ROAT appeared early during the investigative period. Conclusions The algorithm used in this study was not substantiated in this ROAT set-up. The stronger the patch test reactivity the more likely was a positive ROAT and the more likely it was that the positive ROAT appeared early during the application period. What's already known about this topic? To the best of our knowledge, a scientifically designed and conducted repeated open application test (ROAT) has never been performed before to validate a diagnosis of allergic contact dermatitis partly based on a questionnaire. What does this study add? This is the largest controlled, randomized and blinded ROAT performed to date. Higher patch test reactivity to fragrance mix I indicated a greater likelihood of a positive ROAT

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

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