Commentaries

Hand eczema is the main occupational skin disease and, not unexpectedly, it has far-reaching consequences not only for the individual’s ability to maintain employment, but also for public economy. The study shows that consequences such as sickleave, loss of a job, problems getting a job, and being obliged to change job are most frequent among women, and also that health-related quality of life is more strongly influenced in women. In addition, hand eczema is more common among women than men, a fact usually attributed to women’s more frequent wet exposure both at work and in the home.2 The uneven sex distribution of hand eczema and its consequences poses a challenge in terms of prevention and treatment. It is of great interest to learn what factors have an impact on the prognosis of hand eczema and why the lesions tend to heal poorly and recur frequently. To be able to influence the course of the disease, knowledge on risk factors is crucial. The study published in this issue found two main risk factors for a poor prognosis: severe hand eczema at baseline and occurrence of eczema on locations other than the hands. Studies that probe factors of importance for the prognosis of hand eczema are welcome. One interesting observation is that only 40% of the study’s patients with hand eczema visited a dermatologist during the 7 years of follow-up, and only 7% of them were prescribed oral treatment for their condition. This prompts the authors to ask whether closer medical follow-up and more aggressive therapy might be a way to improve the prognosis. In an earlier qualitative study, also done in Denmark, patients with hand eczema expressed that they lacked information about and strategies for how to manage their disease.3 Exposure to skin irritant factors and contact allergens is generally considered a central factor in the occurrence of hand eczema and probably also influences the prognosis. A sharper focus on skin exposure – including assessments of exposure magnitude and ways to reduce exposure – might give clues about how to improve the poor prognosis. Funding sources No external funding. Conflicts of interest None declared. Unit of Occupational and Environmental Dermatology, Institute of Environmental Medicine, Karolinska Institutet, Box 210, SE-171 77 Stockholm, Sweden E-mail: [email protected]

B. MEDING

References 1 Petersen AH, Johansen JD, Hald M. Hand eczema – prognosis and consequences: a 7-year follow-up study. Br J Dermatol 2014; 171:1428–33. © 2014 British Association of Dermatologists

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2 Meding B, Lindahl G, Alderling M et al. Is skin exposure to water mainly occupational or nonoccupational? A population-based study Br J Dermatol 2013; 168:1281–6. 3 Mollerup A, Johansen JD, Thing LF. Knowledge, attitudes and behavior in everyday life with chronic hand eczema: a qualitative study. Br J Dermatol 2013; 169:1056–65.

Hidradenitis suppurativa outcome measures and treatment goals DOI: 10.1111/bjd.13396 ORIGINAL ARTICLE, p 1434 Personalized medicine, in which patient characteristics such as demographics, disease phenotype and pharmacogenetics are used to predict response to an array of treatment options, is seen as the way forward for many chronic inflammatory diseases. Hidradenitis suppurativa (HS) is no different, but HS research still has to go through several prior steps before this approach can be contemplated. One key area is to develop validated HS outcome measures in order to define treatment response in HS. There are several physician-reported outcome measures already available for HS, but each has some limitations. The Hurley scale1 is an ordinal measure with only three levels, making it relatively unresponsive to change. The modified Sartorius scale2 requires a count of HS lesions and measurement of the distance between them in each affected site. While it has been used in clinical trials, it may take too long to complete for widespread use at the coalface of clinical practice. The need for a simple, quick HS outcome measure was highlighted in the recent HS Priority Setting Partnership, which included the question, ‘Can a better hidradenitis suppurativa severity scoring system be devised that is practical to use?’3 One of the largest HS clinical trials to date,4 involving 154 participants and lasting 12 months, provided a good opportunity to develop a new physician-reported outcome measure. In this edition of the BJD, Kimball et al.5 report on development of Hidradenitis Suppurativa Clinical Response (HiSCR), developed retrospectively from the comprehensive clinical data collected during the trial. Three clearly defined HS inflammatory lesion types are counted: abscesses, inflammatory nodules and fistulae. Treatment response is defined as at least a 50% reduction in the combined number of abscesses and inflammatory nodules, along with no increase in the number of fistulae. The authors were able to use the screening and baseline trial visits to demonstrate good test–retest reliability. The set-up of the clinical trial also permitted demonstration of quite strong predictive validity, in which responders at the end of the 16-week randomized phase of the trial were more likely to be responders after 1 year, compared with initial nonresponders. There was high convergent validity between HiSCR and the HS physician’s global assessment, which counts the same type of HS lesions, and also the modified Sartorius British Journal of Dermatology (2014) 171, pp1285–1299

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scale. However, correlation was less good between HiSCR and patient-reported outcome measures (PROMs). Convergent validity was less than the 04 Spearman’s rho correlation needed for moderate correlation for both the Dermatology Life Quality Index (DLQI) and pain visual analogue scale (VAS). The authors have carefully justified the 50% reduction in inflammatory lesions from baseline as the definition of clinical response by demonstrating that a higher threshold is not associated with greater improvements in DLQI or pain VAS scores. The HiSCR outcome measure may not provide the whole story because of the lack of convergent validity with HS PROMs; this may be akin to psoriasis in terms of needing both the Psoriasis Area and Severity Index and a quality-of-life score to capture fully the disease severity information.6 It should be mentioned that HiSCR is relevant only to inflammatory lesions, and so surgical excision treatment, one aim of which is to treat areas of scarring, may require an alternative scale. The authors acknowledge that inter- and intraobserver reliability has not yet been examined fully, and will be important to check because the subcutaneous inflammatory lesions of HS may be less easy to count than lesions in acne, for example. Kimball et al. have made excellent use of their clinical trial data both to develop a novel HS end point and to provide evidence of its reliability, validity, responsiveness and clinical meaningfulness. It will be very interesting to see how HiSCR performs when used prospectively as an HS trial end point and in standard clinical practice settings.

Acknowledgments Professor Andrew Finlay, affiliated to the Department of Dermatology & Wound Healing, Cardiff University, kindly reviewed a previous version of this manuscript. Funding sources None. Conflicts of interest J.R.I. is recruiting into a noninterventional, observational hidradenitis suppurativa study sponsored by AbbVie. Department of Dermatology & Wound Healing, Institute of Infection & Immunity, Cardiff University, Heath Park, Cardiff CF14 4XN, U.K. E-mail: [email protected]

J.R. INGRAM

References 1 Hurley HJ. Axillary hyperhidrosis, apocrine bromhidrosis, hidradenitis suppurativa, and familial benign pemphigus: surgical approach. In: Dermatologic Surgery (Roenigk RK, Roenigk HH, eds). New York: Marcel Dekker, 1996; 623–45. 2 Sartorius K, Emtestam L, Jemec GB, Lapins J. Objective scoring of hidradenitis suppurativa reflecting the role of tobacco smoking and obesity. Br J Dermatol 2009; 161:831–9. British Journal of Dermatology (2014) 171, pp1285–1299

3 Ingram JR, Abbott R, Ghazavi M et al. The Hidradenitis Suppurativa Priority Setting Partnership. Br J Dermatol 2014; 171:1422–7. 4 Kimball AB, Kerdel F, Adams D et al. Adalimumab for the treatment of moderate to severe hidradenitis suppurativa: a parallel randomized trial. Ann Intern Med 2012; 157:846–55. 5 Kimball AB, Jemec GBE, Yang M et al. Assessing the validity, responsiveness and meaningfulness of the Hidradenitis Suppurativa Clinical Response (HiSCR) as the clinical endpoint for hidradenitis suppurativa treatment. Br J Dermatol 2014; 171:1434–42. 6 Finlay AY. Current severe psoriasis and the rule of tens. Br J Dermatol 2005; 152:861–7.

Essential inputs for studies of costeffectiveness analysis in melanoma DOI: 10.1111/bjd.13455 ORIGINAL ARTICLE, p 1443 Health-related quality of life, measured in either ‘utilities’ or ‘disability weights’ is an essential component of cost-effectiveness analysis and burden of disease studies. Decision-analytic models, which underpin most of the comparative analysis of submissions to health technology assessment agencies such as National Institute for Health and Care Excellence (NICE), Canadian Agency for Drugs and Technologies in Health (CADTH) and Pharmaceutical Benefits Advisory Committee (PBAC), require good data on utility-based quality of life for the calculation of quality-adjusted life years (QALYs).1–3 Until now, the available data on utility-based quality of life for each American Joint Cancer Committee (AJCC) melanoma stage has been limited to a few prospective studies with small numbers of participants. In the article that accompanies this commentary, Tromme et al.4 present mean utilities and disability weights for both melanoma treatment and remission (i.e. follow-up) health states. The authors are to be commended for their robust calculation of precision estimates using statistical bootstrap methods that allow health economists and modellers to incorporate upper and lower limits into sensitivity analyses. Two important points concerning the empiric measurement of health-related quality of life for patients with melanoma need to be highlighted. The first is that the instruments or questionnaires used should be sensitive to the domains of quality of life that are likely to change as a result of the disease, the routine treatment or a targeted intervention. Tromme et al.4 describe that over half the patients with melanoma in their study reported anxiety or depression; however, this domain on the EQ-5D-5L instrument was somewhat insensitive to detecting this health state.4 Similar findings are reported in a review of existing quality of life instruments where little attention was given to psychosocial or emotional wellbeing, two of the issues most pertinent to patients with melanoma.5 Given this, clinician researchers should question whether the EQ-5D-5L © 2014 British Association of Dermatologists

Hidradenitis suppurativa outcome measures and treatment goals.

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