Accepted Manuscript. Building a scale for measuring burden of hand eczema: BoHEM
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1 Accepted Manuscript Building a scale for measuring burden of hand eczema: BoHEM François Maccari, MD, Khaled Ezzedine, MD, Anne Claire Fougerousse, MD, Stéphanie Mérhand, PhD, Charles Bordet, MSc, Caroline Jacobzone, MD, Charles Taieb, MD PII: S (18) DOI: Reference: YMJD To appear in: Journal of the American Academy of Dermatology Received Date: 3 August 2018 Revised Date: 8 December 2018 Accepted Date: 14 December 2018 Please cite this article as: Maccari F, Ezzedine K, Fougerousse AC, Mérhand S, Bordet C, Jacobzone C, Taieb C, Building a scale for measuring burden of hand eczema: BoHEM, Journal of the American Academy of Dermatology (2019), doi: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
2 Epidemiology Journal of the American Academy of Dermatology Research letter Building a scale for measuring burden of hand eczema: BoHEM François Maccari, MD, 1 Khaled Ezzedine, MD, 2 Anne Claire Fougerousse, MD, 3 Stéphanie Mérhand, PhD, 4 Charles Bordet, MSc, 5 Caroline Jacobzone, MD 6,7 and Charles Taieb, MD 8,9 1Dermatology practice, La Varenne Saint Hilaire, France 2EA EpiDermE (Epidémiologie en Dermatologie et Evaluation des Thérapeutiques) UPEC-Université Paris-Est Créteil 3 Dermatology department, Hôpital d instruction des armées, Saint-Mandé, France 4 French Eczema Association, Redon, France 5 Data Champ, Villeurbanne, France 6 Dermatology department, Groupe Hospitalier Bretagne Sud - Hôpital du Scorff, Lorient, France 7 Association Reso Eczema, France 8 FIMARAD, Filière de santé maladies rares: maladies rares en dermatologie; French rare diseases Healthcare Network, Paris, France 9 European Market Maintenance Assessment, Fontenay sous-bois, France Corresponding author: Dr Charles Taieb, EMMA European Market Maintenance Assessment, 18 rue de la Renardière ; Fontenay sous-bois Tel: +33 (0) Fax: +33 (0) Charles.taieb@emma.clinic ; Orcid Word count: 490 words References: 4 Tables: 2 Keywords: chronic eczema; individual disease burden; quality of life Funding sources: This project was supported by an unconditional grant from RESO ECZEMA. 37 Conflict of interests by the authors: none declared
3 To the Editor: Chronic hand eczema (CHE) results in persistent symptoms that interfere with daily activities, social functioning, and workability We failed to find in the literature any specific tool that aimed to assess the burden experienced by patients with CHE. Such a tool would be of valuable for both patients and clinicians that manage daily patients with CHE. Indeed recently, the concept of burden has been given a central role for evaluating patient care. 1 The self-administered BoHEM (Burden of Hand EczeMa) questionnaire was developed using standard methodology that included three distinct phases: conception, developmental, and validation 2. Each phase followed a strict methodological process, implicating a multidisciplinary team of dermatologists, patients, and experts in patient-reported outcomes. The original BoHEM questionnaire was developed in French. A linguistic and cross-cultural validation following a previously-validated methodology 3 was applied in order to generate an American Englishlanguage version. The initial conceptual phase involved 15 patients who shared their complaints, perceptions, and experiences in relation to CHE, following which 15 items were retained and formed the conceptual questionnaire [Two questions were removed because they were not related to a particular factor]. Principal component factor exploratory analysis was performed to test the questionnaire s robustness. Using standardized regression analysis, three dimensions were highlighted (Table I): "daily life" composed of 8 questions; "look of others "[5 questions] and "relationships" [2 questions]. The BoHEM's unidimensionality was confirmed by higher order factor analysis. The practical model-fit indices were acceptable, with a comparative fit index of and a non-normed fit index of The model appeared well-adjusted and well-fitted, offering the possibility to group the three dimensions into one overall score. Concerning its reliability, Cronbach's alpha coefficient 4 was for the entire questionnaire, reflecting its excellent internal coherence. The BoHEM correlated highly with other validated questionnaires. Correlation coefficients between BoHEM and validated questionnaires were relatively high, confirming their strong association and thus, BoHEM s external validity (Table II). Cognitive debriefing did not result in any major changes to questions wording.
4 In last, the test-retest reliability was obtained from 32 evaluable subjects (day zero and day 10), showing very good reproducibility. The intraclass correlation of each dimension was greater than 0.88 for each domain. The BoHEM results can be expressed as a total score between 0 [no impact] and 75 [highest possible impact] There has been so far no specific instrument available to assess the burden of CHE. The current report provides support of BoHEM s feasibility, reliability, and validity as a specific instrument designed to fill this unmet need. With its 15 items, the BoHEM is relatively short and easy to use. The questions are simple and easy to understand so that it can used by anyone. We hope that BoHEM will serve as a valuable tool for healthcare providers to evaluate better patients burden. BoHEM will likely facilitate communication between patients and healthcare providers, create a real opportunity for the practitioner to better understand the multiple issues lived up by the patients References 1 Chren MM, Weinstock MA. Conceptual issues in measuring the burden of skin diseases. J Investig Dermatol Symp Proc. 2004;9: Acquadro C, Conway K, Hareendran A, et al, European Regulatory Issues and Quality of Life Assessment (ERIQA) Group. Literature review of methods to translate health-related quality of life questionnaires for use in multinational clinical trials. Value Health. 2008;11: Wild D, Grove A, Martin M, et al, ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005;8: Cronbach LJ, Warrington WG. Time-limit tests: Estimating their reliability and degree of speeding. Psychometrika. 1951;6:
5 99 Tables Table I. Loading of questions on the factors after rotation Item FACTOR 1 FACTOR 2 FACTOR 3 I have difficulty performing everyday activities My professional activities are impacted I have difficulty grooming (styling hair, washing, shaving) I have had problems at work due to my chronic hand eczema Daily care for my chronic hand eczema is immensely tiring It seems to me that my chronic hand eczema is costing me more and more My chronic hand eczema affects my quality of sleep negatively I believe that my life would have been different without chronic hand eczema When I show my hands, the looks from other people embarrass me I hesitate to shake hands when meeting someone I tend to keep my hands in my pockets I don't know where to put my hands anymore when at work Interacting with others is difficult I have a troubled emotional life The appearance of my hands (redness, dryness) affects my sex life Loadings (correlation coefficients between questions and factors) are computed to facilitate the interpretability of the factors. A loading >0.5 indicates that the couple question-factor is strongly related to each other. A question that does not display a loading >0.5 is not particularly related to any of the selected factors. The questions in Table I are reordered to first show the ones corresponding to Factor 1 (in blue), then to Factor 2 (in green), and lastly to Factor 3 (in grey). We can now interpret factors by looking at the common theme among questions that belong to the same factor. The total score is obtained by summing up the scores for each of the 15 items as follows: "never" or "not applicable" scored 0, "rarely" 1, "sometimes" 2, "often" 3, "very often" 4, and "constantly" resulting in a maximum of 75 and a minimum of 0. The higher the score, the greater the burden of the disease is important
6 114 Table II. Correlation coefficients between BoHEM score and four self-administrated questionnaires 115 Pearson correlation coefficients, N = CES-D PHYSICAL MENTAL PSS DLQI BOHEM Prob > r under H0: Rho=0 CES-D PHYSICAL MENTAL PSS DLQI BOHEM (p=0,36) (p<0,01) 0.78(p<0,01) 0.46(p<0,01) 0.40(p<0,01) (p=0,36) (p=0,02) 0.01(p=0,84) -0.47(p<0,01) -0.42(p<0,01) -0.79(p<0,01) (p=0,02) (p<0,01) -0.43(p<0,01) -0.37(p<0,01) 0.78(p<0,01) 0.01 (p=0,84) (p<0,01) (p<0,01) 0.33(p<0,01) 0.46 (p<0,01) (p<0,01) (p<0,01) 0.36(p<0,01) (p<0,01) 0.40 (p<0,01) (p<0,01) -0.37(p<0,01) 0.33(p<0,01) 0.79(p<0,01) 1 Significant p-values indicate that our score is strongly related to validated scores, hence confirming the external score validity with our methodology.
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